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Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis

Primary Purpose

Anemia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Roxadustat

Placebo

About this trial

This is an interventional treatment trial for Anemia focused on measuring Renal,, CKD,, Roxadustat,, anemia,, non-dialysis

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures.
Age ≥18 years at screening visit 1
eGFR <60 mL/min/1.73 m2, (calculated by central lab) corresponding to stage 3, 4 or 5CKD according to the Kidney Disease Outcomes Quality Initiative (KDOQI), not receiving dialysis
Mean of 2 most recent central laboratory Hb values during the screening period, obtained at least 7 days apart, must be <10.0 g/dL
Ferritin ≥50 ng/mL at randomization (obtained from screening visit)
TSAT ≥15 % at randomization (obtained from screening visit)
Serum folate level ≥ lower limit of normal (LLN) at randomization (obtained from screening visit)
Serum vitamin B12 level ≥LLN at randomization (obtained from screening visit)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) and total bilirubin (Tbili) ≤1.5 x ULN at randomization (obtained from screening visit)
Body weight 45 to 160 kg

Exclusion Criteria:

Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Previous randomization in the present study
Any erythropoietin analogue treatment within 6 weeks of randomization
New York Heart Association Class III or IV congestive heart failure at enrollment
Myocardial infarction (MI), acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization
History of chronic liver disease (e.g., chronic infectious hepatitis, chronic auto- immune liver disease, cirrhosis or fibrosis of the liver)
Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD
Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis)
Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g. CT scan or MRI) conducted at screening or within 12 weeks prior to randomization
Systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg (confirmed by repeated measurement), within 2 weeks prior to randomization. Patients may be rescreened once BP controlled
History of prostate cancer, breast cancer or any other malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab)
Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be the principal cause of anemia
Known hemosiderosis, hemochromatosis or hypercoagulable condition
Any prior organ transplant or a scheduled organ transplantation date
Any red blood cell transfusion (RBC) during the screening period
Any current condition leading to active significant blood loss
Any treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 1 month of the first administration of IP in this study. (Note: patients consented and screened, but not randomized in this study or a previous study are not excluded)
History of alcohol or drug abuse within 2 years prior to randomization
Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence
Pregnant or breastfeeding females
Known allergy to the investigational product or any of its ingredients
Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound efficacy or safety assessment or may interfere with study participation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Roxadustat

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to mean value from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation analysis of covariance (ANCOVA) model with baseline Hb, baseline estimated glomerular filtration rate (eGFR), cardiovascular (CV) history, geographic region and treatment group as fixed effect covariates. The adjusted least squares (LS) mean estimates of change from baseline to mean during Week 28 to Week 52 are presented.

Secondary Outcome Measures

Percentage of Participants With Hb Response During the First 24 Weeks of Treatment

Hb response was defined as: Hb ≥ 11.0 g/dL and Hb increase from baseline by ≥ 1.0 g/dL for participants with baseline Hb > 8.0 g/dL; or Hb increase from baseline by ≥ 2.0 g/dL, for participants with baseline Hb ≤ 8.0 g/dL at 2 consecutive visits (with available data) separated at least 5 days during the first 24 weeks of treatment without having received rescue therapy (red blood cell [RBC] transfusion, erythropoietin analogue, or intravenous [IV] iron) prior to Hb response. The percentage of participants with an Hb response during the first 24 weeks of treatment is presented.

Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 in Participants With Baseline High Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN)

Baseline hsCRP was quantified from stored biomarker samples obtained at randomization. Baseline Hb was defined as the mean of the last 3 central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to mean value during Week 28 to Week 52 was analyzed using a MAR based multiple imputation ANCOVA model with baseline Hb, baseline eGFR, CV history, geographic region and treatment group as fixed effect covariates. The adjusted LS mean estimates of change from baseline in participants with baseline hsCRP >ULN to mean during Week 28 to Week 52 are presented.

Proportion of Total Time of Interpolated Hb Values Greater Than or Equal To 10 g/dL From Week 28 to Week 52

Proportion of total time of interpolated Hb values ≥10 g/dL was calculated as the time the linearly interpolated curve between measurements ≥10 g/dL divided by the time between measurements from Week 28 to Week 52. Proportion of total time was analyzed using an ANCOVA model with baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from Week 28 to Week 52 are presented.

Proportion of Total Time of Interpolated Hb Values Within the Interval of 10 to 12 g/dL From Week 28 to Week 52

Proportion of total time of interpolated Hb values within the interval of 10 to 12 g/dL was calculated as the time the linearly interpolated curve between measurements were within 10 to 12 g/dL divided by the time between measurements from Week 28 to Week 52. Proportion of total time was analyzed using an ANCOVA model with baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from Week 28 to Week 52 are presented.

Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24

Baseline LDL was defined as the last result obtained prior to randomization. Mean changes in LDL cholesterol from baseline to Week 24 was analyzed using an ANCOVA model with baseline LDL, baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from baseline to Week 24 are presented.

Time-To-First Instance of Receiving IV Iron, RBC Transfusion or Erythropoietin Analogue as Rescue Therapy

Time-to-first rescue therapy (IV iron, RBC transfusion or erythropoietin analogue) was calculated as (date of first rescue therapy, or date of censoring if no rescue therapy was taken) minus (date of first dose of IP) +1. Event rate was calculated as (number of participants with event) divided by (the total number of days at risk for event across all participants in given group divided by 365.25) multiplied by 100. The event rate is presented for participants with events.

Time-To-First Instance of Receiving a RBC Transfusion As Rescue Therapy

Time-to-first RBC rescue therapy was calculated as (date of first RBC rescue therapy, or date of censoring if no rescue therapy was taken) minus (date of first dose of IP) +1. Event rate was calculated as (number of participants with event) divided by (the total number of days at risk for event across all participants in given group divided by 365.25) multiplied by 100. The event rate is presented for participants with events.

Mean Change From Baseline in Short Form 36 (SF-36) Vitality Sub-Score From Week 12 to Week 28

SF-36 is a Quality of Life (QoL) scale comprising 8 domains of health status: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Each domain score is on a scale from 0-100 (worst health possible to best health possible); higher scores indicate better health status. Mean change in SF-36 Vitality sub-score from baseline to mean from Week 12 to Week 28 was analyzed using a mixed model for repeated measures (MMRM) with terms for baseline score, treatment group, baseline Hb, baseline eGFR, CV history, geographic region, visit and treatment-by-visit interaction as fixed effects and participant as random effect. The adjusted LS mean estimates of change from baseline to mean score from Week 12 to Week 28 are presented.

Annual Rate of eGFR Change From Baseline Prior to the Initiation of Dialysis or Kidney Transplant

Baseline eGFR was defined as the mean of all available central laboratory values prior to or at randomization. Rate of change in eGFR from baseline during the entire treatment period (in millilitres/minute/1.73 meters squared/years [mL/min/1.73m^2/years]) was estimated using a random effects model using all post-baseline eGFR values prior to initiation of dialysis/transplant. Baseline eGFR, baseline Hb, geographic region, CV history, treatment group and post-baseline eGFR measurement time were used as fixed effects and participant and time (years) as random effects, ie, random intercept and slope.

Mean Change From Baseline in SF-36 Physical Functioning Sub-Score From Week 12 to Week 28

SF-36 is a QoL scale comprising 8 domains of health status: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Each domain score is on a scale from 0-100 (worst health possible to best health possible); higher scores indicate better health status. Mean change in SF-36 Physical Functioning sub-score from baseline to mean from Week 12 to Week 28 was analyzed using a MMRM with terms for baseline score, treatment group, baseline Hb, baseline eGFR, CV history, geographic region, visit and treatment-by-visit interaction as fixed effects and participant as random effect. The adjusted LS mean estimates of change from baseline to mean score from Week 12 to Week 28 are presented.

Full Information

NCT ID

NCT02174627

First Posted

June 24, 2014

Last Updated

November 27, 2019

Sponsor

AstraZeneca

Collaborators

FibroGen

1. Study Identification

Unique Protocol Identification Number

NCT02174627

Brief Title

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis

Official Title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

June 26, 2014 (Actual)

Primary Completion Date

October 4, 2018 (Actual)

Study Completion Date

October 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

FibroGen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis

Detailed Description

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in anemic patients with Stage 3, 4 or 5 chronic kidney disease (CKD) who are not on dialysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia

Keywords

Renal,, CKD,, Roxadustat,, anemia,, non-dialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2781 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Roxadustat

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Roxadustat

Intervention Description

The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.

Primary Outcome Measure Information:

Title

Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52

Description

Time Frame

Baseline (Day 1, Week 0) and Week 28 to Week 52.

Secondary Outcome Measure Information:

Title

Percentage of Participants With Hb Response During the First 24 Weeks of Treatment

Description

Time Frame

Baseline (Day 1, Week 0) up to Week 24.

Title

Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 in Participants With Baseline High Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN)

Description

Time Frame

Baseline (Day 1, Week 0) and Week 28 to Week 52.

Title

Proportion of Total Time of Interpolated Hb Values Greater Than or Equal To 10 g/dL From Week 28 to Week 52

Description

Time Frame

Week 28 up to Week 52.

Title

Proportion of Total Time of Interpolated Hb Values Within the Interval of 10 to 12 g/dL From Week 28 to Week 52

Description

Time Frame

Week 28 up to Week 52.

Title

Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24

Description

Time Frame

Baseline (Day 1, Week 0) and Week 24

Title

Time-To-First Instance of Receiving IV Iron, RBC Transfusion or Erythropoietin Analogue as Rescue Therapy

Description

Time Frame

Baseline (Day1, Week 0) up to End of Study (EOS) visit (4 weeks after the treatment period) (or up to date of first rescue therapy), with treatment duration up to 4 years.

Title

Time-To-First Instance of Receiving a RBC Transfusion As Rescue Therapy

Description

Time Frame

Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period) (or up to date of first RBC rescue therapy), with treatment duration up to 4 years.

Title

Mean Change From Baseline in Short Form 36 (SF-36) Vitality Sub-Score From Week 12 to Week 28

Description

Time Frame

Baseline (Day 1, Week 0) and Week 12 to Week 28.

Title

Annual Rate of eGFR Change From Baseline Prior to the Initiation of Dialysis or Kidney Transplant

Description

Time Frame

Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period), with treatment duration up to 4 years.

Title

Mean Change From Baseline in SF-36 Physical Functioning Sub-Score From Week 12 to Week 28

Description

Time Frame

Baseline (Day 1, Week 0) and Week 12 to Week 28.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of informed consent prior to any study specific procedures. Age ≥18 years at screening visit 1 eGFR <60 mL/min/1.73 m2, (calculated by central lab) corresponding to stage 3, 4 or 5CKD according to the Kidney Disease Outcomes Quality Initiative (KDOQI), not receiving dialysis Mean of 2 most recent central laboratory Hb values during the screening period, obtained at least 7 days apart, must be <10.0 g/dL Ferritin ≥50 ng/mL at randomization (obtained from screening visit) TSAT ≥15 % at randomization (obtained from screening visit) Serum folate level ≥ lower limit of normal (LLN) at randomization (obtained from screening visit) Serum vitamin B12 level ≥LLN at randomization (obtained from screening visit) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) and total bilirubin (Tbili) ≤1.5 x ULN at randomization (obtained from screening visit) Body weight 45 to 160 kg Exclusion Criteria: Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) Previous randomization in the present study Any erythropoietin analogue treatment within 6 weeks of randomization New York Heart Association Class III or IV congestive heart failure at enrollment Myocardial infarction (MI), acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization History of chronic liver disease (e.g., chronic infectious hepatitis, chronic auto- immune liver disease, cirrhosis or fibrosis of the liver) Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis) Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g. CT scan or MRI) conducted at screening or within 12 weeks prior to randomization Systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg (confirmed by repeated measurement), within 2 weeks prior to randomization. Patients may be rescreened once BP controlled History of prostate cancer, breast cancer or any other malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab) Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be the principal cause of anemia Known hemosiderosis, hemochromatosis or hypercoagulable condition Any prior organ transplant or a scheduled organ transplantation date Any red blood cell transfusion (RBC) during the screening period Any current condition leading to active significant blood loss Any treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 1 month of the first administration of IP in this study. (Note: patients consented and screened, but not randomized in this study or a previous study are not excluded) History of alcohol or drug abuse within 2 years prior to randomization Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence Pregnant or breastfeeding females Known allergy to the investigational product or any of its ingredients Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound efficacy or safety assessment or may interfere with study participation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Fishbane, MD

Organizational Affiliation

Chief Division of Kidney Diseases and Hypertension, North Shore University Hospital, Great Neck, NY, USA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mark Houser, MD

Organizational Affiliation

AZ R&D Gaithersburg, USA

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Research Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35805

Country

United States

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85027

Country

United States

Facility Name

Research Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Research Site

City

El Centro

State/Province

California

ZIP/Postal Code

92243

Country

United States

Facility Name

Research Site

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Research Site

City

Glendale

State/Province

California

ZIP/Postal Code

91204

Country

United States

Facility Name

Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Research Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90807

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90022

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Research Site

City

Lynwood

State/Province

California

ZIP/Postal Code

90262

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United States

Facility Name

Research Site

City

National City

State/Province

California

ZIP/Postal Code

91950

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United States

Facility Name

Research Site

City

Northridge

State/Province

California

ZIP/Postal Code

91324

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United States

Facility Name

Research Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

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United States

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Research Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

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United States

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Research Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95831

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United States

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Research Site

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San Diego

State/Province

California

ZIP/Postal Code

92103

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United States

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Research Site

City

San Dimas

State/Province

California

ZIP/Postal Code

91773

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United States

Facility Name

Research Site

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San Francisco

State/Province

California

ZIP/Postal Code

94110

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United States

Facility Name

Research Site

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San Luis Obispo

State/Province

California

ZIP/Postal Code

93401

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United States

Facility Name

Research Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

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United States

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Research Site

City

Arvada

State/Province

Colorado

ZIP/Postal Code

80002

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United States

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Research Site

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

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United States

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Research Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

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United States

Facility Name

Research Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

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United States

Facility Name

Research Site

City

Coral Springs

State/Province

Florida

ZIP/Postal Code

33071

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United States

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Research Site

City

Edgewater

State/Province

Florida

ZIP/Postal Code

32132

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United States

Facility Name

Research Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

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United States

Facility Name

Research Site

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34741

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United States

Facility Name

Research Site

City

Lauderdale Lakes

State/Province

Florida

ZIP/Postal Code

33313

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United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33130

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33145

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33150

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Research Site

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31901

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Research Site

City

Joliet

State/Province

Illinois

ZIP/Postal Code

60435

Country

United States

Facility Name

Research Site

City

La Grange

State/Province

Illinois

ZIP/Postal Code

60525

Country

United States

Facility Name

Research Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

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United States

Facility Name

Research Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

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United States

Facility Name

Research Site

City

Rockport

State/Province

Maine

ZIP/Postal Code

04856

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United States

Facility Name

Research Site

City

Greenbelt

State/Province

Maryland

ZIP/Postal Code

20770

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United States

Facility Name

Research Site

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Rockville

State/Province

Maryland

ZIP/Postal Code

20852

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United States

Facility Name

Research Site

City

Port Huron

State/Province

Michigan

ZIP/Postal Code

48060

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United States

Facility Name

Research Site

City

Gulfport

State/Province

Mississippi

ZIP/Postal Code

39501

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United States

Facility Name

Research Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

Research Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68124

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Research Site

City

Reno

State/Province

Nevada

ZIP/Postal Code

89511

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

New Hampshire

ZIP/Postal Code

03867

Country

United States

Facility Name

Research Site

City

Flushing

State/Province

New York

ZIP/Postal Code

11355

Country

United States

Facility Name

Research Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Research Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

North Carolina

ZIP/Postal Code

28546

Country

United States

Facility Name

Research Site

City

New Bern

State/Province

North Carolina

ZIP/Postal Code

28562

Country

United States

Facility Name

Research Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45206

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45220

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

Research Site

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18017

Country

United States

Facility Name

Research Site

City

Lansdale

State/Province

Pennsylvania

ZIP/Postal Code

19446

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Research Site

City

Uniontown

State/Province

Pennsylvania

ZIP/Postal Code

15401

Country

United States

Facility Name

Research Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02908

Country

United States

Facility Name

Research Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02915

Country

United States

Facility Name

Research Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29203

Country

United States

Facility Name

Research Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37923

Country

United States

Facility Name

Research Site

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78404

Country

United States

Facility Name

Research Site

City

Cypress

State/Province

Texas

ZIP/Postal Code

77429

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77084

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77099

Country

United States

Facility Name

Research Site

City

Lufkin

State/Province

Texas

ZIP/Postal Code

75904

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78207

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78212

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Research Site

City

Saint George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84115

Country

United States

Facility Name

Research Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Research Site

City

Salem

State/Province

Virginia

ZIP/Postal Code

24153

Country

United States

Facility Name

Research Site

City

Woodbridge

State/Province

Virginia

ZIP/Postal Code

22191

Country

United States

Facility Name

Research Site

City

Caba

ZIP/Postal Code

C1012AAR

Country

Argentina

Facility Name

Research Site

City

Caba

ZIP/Postal Code

C1440AAD

Country

Argentina

Facility Name

Research Site

City

Capital Federal

ZIP/Postal Code

C1425AGC

Country

Argentina

Facility Name

Research Site

City

Ciudad Autónoma de Bs. As.

ZIP/Postal Code

C1199ABB

Country

Argentina

Facility Name

Research Site

City

Ciudadela

ZIP/Postal Code

1702

Country

Argentina

Facility Name

Research Site

City

La Plata

ZIP/Postal Code

1900

Country

Argentina

Facility Name

Research Site

City

La Plata

ZIP/Postal Code

C1427ARO

Country

Argentina

Facility Name

Research Site

City

Lanus

ZIP/Postal Code

B1824KAJ

Country

Argentina

Facility Name

Research Site

City

Mar del Plata

ZIP/Postal Code

7600

Country

Argentina

Facility Name

Research Site

City

Munro

ZIP/Postal Code

1605

Country

Argentina

Facility Name

Research Site

City

Ramos Mejía

ZIP/Postal Code

B1704ETD

Country

Argentina

Facility Name

Research Site

City

Rosario

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Research Site

City

Rosario

ZIP/Postal Code

S2000DNM

Country

Argentina

Facility Name

Research Site

City

San Isidro

ZIP/Postal Code

B1642DCD

Country

Argentina

Facility Name

Research Site

City

San Miguel de Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Research Site

City

Santa Rosa

ZIP/Postal Code

6300

Country

Argentina

Facility Name

Research Site

City

Curitiba

ZIP/Postal Code

80230-130

Country

Brazil

Facility Name

Research Site

City

Curitiba

ZIP/Postal Code

80440-020

Country

Brazil

Facility Name

Research Site

City

Curitiba

ZIP/Postal Code

80810-040

Country

Brazil

Facility Name

Research Site

City

Feira de Santana

ZIP/Postal Code

44001-584

Country

Brazil

Facility Name

Research Site

City

Fortaleza

ZIP/Postal Code

60115282

Country

Brazil

Facility Name

Research Site

City

Fortaleza

ZIP/Postal Code

60430-350

Country

Brazil

Facility Name

Research Site

City

Fortaleza

ZIP/Postal Code

60430-370

Country

Brazil

Facility Name

Research Site

City

Goiânia

ZIP/Postal Code

74043-011

Country

Brazil

Facility Name

Research Site

City

Joinville

Country

Brazil

Facility Name

Research Site

City

Juiz de Fora

ZIP/Postal Code

36036-330

Country

Brazil

Facility Name

Research Site

City

Maringa

ZIP/Postal Code

87083-240

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90160-093

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Research Site

City

Sao Bernardo do Campo

ZIP/Postal Code

09715090

Country

Brazil

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

01323-030

Country

Brazil

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

08270-070

Country

Brazil

Facility Name

Research Site

City

São Paulo

ZIP/Postal Code

04039-000

Country

Brazil

Facility Name

Research Site

City

Botevgrad

ZIP/Postal Code

2140

Country

Bulgaria

Facility Name

Research Site

City

Dupnitsa

ZIP/Postal Code

2600

Country

Bulgaria

Facility Name

Research Site

City

Gotse Delchev

ZIP/Postal Code

2900

Country

Bulgaria

Facility Name

Research Site

City

Haskovo

ZIP/Postal Code

6300

Country

Bulgaria

Facility Name

Research Site

City

Kozloduy

ZIP/Postal Code

3320

Country

Bulgaria

Facility Name

Research Site

City

Samokov

ZIP/Postal Code

2000

Country

Bulgaria

Facility Name

Research Site

City

Sandanski

ZIP/Postal Code

2800

Country

Bulgaria

Facility Name

Research Site

City

Silistra

ZIP/Postal Code

7500

Country

Bulgaria

Facility Name

Research Site

City

Sliven

ZIP/Postal Code

8800

Country

Bulgaria

Facility Name

Research Site

City

Smolyan

ZIP/Postal Code

3700

Country

Bulgaria

Facility Name

Research Site

City

Yambol

ZIP/Postal Code

8600

Country

Bulgaria

Facility Name

Research Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Research Site

City

Kamloops

State/Province

British Columbia

ZIP/Postal Code

V2C 2T1

Country

Canada

Facility Name

Research Site

City

New Westminster

State/Province

British Columbia

ZIP/Postal Code

V3L 0A6

Country

Canada

Facility Name

Research Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2V 3M3

Country

Canada

Facility Name

Research Site

City

Saint John

State/Province

New Brunswick

ZIP/Postal Code

E2L 4L2

Country

Canada

Facility Name

Research Site

City

Sydney

State/Province

Nova Scotia

ZIP/Postal Code

B1P 1P3

Country

Canada

Facility Name

Research Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6R 3J7

Country

Canada

Facility Name

Research Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

Research Site

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2H 5Z8

Country

Canada

Facility Name

Research Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Research Site

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6K 3V3

Country

Canada

Facility Name

Research Site

City

Scarborough

State/Province

Ontario

ZIP/Postal Code

M1H 3G4

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4C 5T2

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4S 1Y2

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5C 2T2

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9N 1N8

Country

Canada

Facility Name

Research Site

City

Whitby

State/Province

Ontario

ZIP/Postal Code

L1N 5T2

Country

Canada

Facility Name

Research Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8Y 6S8

Country

Canada

Facility Name

Research Site

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H1

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Research Site

City

Cali

ZIP/Postal Code

760032

Country

Colombia

Facility Name

Research Site

City

Chia

ZIP/Postal Code

250008

Country

Colombia

Facility Name

Research Site

City

Medellin

ZIP/Postal Code

5001000

Country

Colombia

Facility Name

Research Site

City

Zipaquira

ZIP/Postal Code

250258

Country

Colombia

Facility Name

Research Site

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Research Site

City

Havlickuv Brod

ZIP/Postal Code

580 22

Country

Czechia

Facility Name

Research Site

City

Ivancice

ZIP/Postal Code

664 91

Country

Czechia

Facility Name

Research Site

City

Praha

ZIP/Postal Code

190 61

Country

Czechia

Facility Name

Research Site

City

Rychnov nad Kneznou

ZIP/Postal Code

516 01

Country

Czechia

Facility Name

Research Site

City

Slany

ZIP/Postal Code

274 01

Country

Czechia

Facility Name

Research Site

City

Slavkov u Brna

Country

Czechia

Facility Name

Research Site

City

Sumperk

ZIP/Postal Code

787 01

Country

Czechia

Facility Name

Research Site

City

Usti nad Labem

ZIP/Postal Code

401 13

Country

Czechia

Facility Name

Research Site

City

Usti nad Orlici

ZIP/Postal Code

562 18

Country

Czechia

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Research Site

City

Cloppenburg

ZIP/Postal Code

49661

Country

Germany

Facility Name

Research Site

City

Köln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Research Site

City

Ajka

ZIP/Postal Code

8400

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1096

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Research Site

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Research Site

City

Hatvan

ZIP/Postal Code

3000

Country

Hungary

Facility Name

Research Site

City

Kecskemét

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Research Site

City

Nyíregyháza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Research Site

City

Polgár

ZIP/Postal Code

4090

Country

Hungary

Facility Name

Research Site

City

Pécs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

Research Site

City

Salgótarján

ZIP/Postal Code

3100

Country

Hungary

Facility Name

Research Site

City

Siófok

ZIP/Postal Code

8600

Country

Hungary

Facility Name

Research Site

City

Tatabánya

ZIP/Postal Code

2800

Country

Hungary

Facility Name

Research Site

City

Velence

ZIP/Postal Code

2481

Country

Hungary

Facility Name

Research Site

City

Ahmedabad

ZIP/Postal Code

380016

Country

India

Facility Name

Research Site

City

Bangalore

ZIP/Postal Code

560052

Country

India

Facility Name

Research Site

City

Bangalore

ZIP/Postal Code

560068

Country

India

Facility Name

Research Site

City

Bangalore

ZIP/Postal Code

560070

Country

India

Facility Name

Research Site

City

Chennai

ZIP/Postal Code

600006

Country

India

Facility Name

Research Site

City

Ghaziabad NCR

ZIP/Postal Code

201012

Country

India

Facility Name

Research Site

City

Hyderabad

ZIP/Postal Code

500018

Country

India

Facility Name

Research Site

City

Hyderabad

ZIP/Postal Code

500072

Country

India

Facility Name

Research Site

City

Kolkatta

ZIP/Postal Code

700027

Country

India

Facility Name

Research Site

City

Lucknow

ZIP/Postal Code

226003

Country

India

Facility Name

Research Site

City

Maharashtra

ZIP/Postal Code

411013

Country

India

Facility Name

Research Site

City

Mumbai

ZIP/Postal Code

400008

Country

India

Facility Name

Research Site

City

Mysore

ZIP/Postal Code

570004

Country

India

Facility Name

Research Site

City

Nagpur

ZIP/Postal Code

420012

Country

India

Facility Name

Research Site

City

Nagpur

ZIP/Postal Code

440003

Country

India

Facility Name

Research Site

City

Nagpur

ZIP/Postal Code

440012

Country

India

Facility Name

Research Site

City

New Delhi

ZIP/Postal Code

110017

Country

India

Facility Name

Research Site

City

New Delhi

ZIP/Postal Code

110060

Country

India

Facility Name

Research Site

City

Pune

ZIP/Postal Code

411001

Country

India

Facility Name

Research Site

City

Vijayawada

ZIP/Postal Code

520 008

Country

India

Facility Name

Research Site

City

Vijayawada

ZIP/Postal Code

522002

Country

India

Facility Name

Research Site

City

Vishakhapatnam

ZIP/Postal Code

530002

Country

India

Facility Name

Research Site

City

Ansan-si

ZIP/Postal Code

15355

Country

Korea, Republic of

Facility Name

Research Site

City

Busan

ZIP/Postal Code

49241

Country

Korea, Republic of

Facility Name

Research Site

City

Daegu

ZIP/Postal Code

42415

Country

Korea, Republic of

Facility Name

Research Site

City

Daejeon

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

Research Site

City

Goyang-si

ZIP/Postal Code

10380

Country

Korea, Republic of

Facility Name

Research Site

City

Goyang-si

ZIP/Postal Code

10444

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

403-720

Country

Korea, Republic of

Facility Name

Research Site

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03312

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06273

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

139-711

Country

Korea, Republic of

Facility Name

Research Site

City

Uijeongbu-si

ZIP/Postal Code

11765

Country

Korea, Republic of

Facility Name

Research Site

City

George Town

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

Research Site

City

Kubang Kerian

ZIP/Postal Code

16150

Country

Malaysia

Facility Name

Research Site

City

Putrajaya

ZIP/Postal Code

62250

Country

Malaysia

Facility Name

Research Site

City

Taiping

ZIP/Postal Code

34000

Country

Malaysia

Facility Name

Research Site

City

Aguascalientes

ZIP/Postal Code

20219

Country

Mexico

Facility Name

Research Site

City

Culiacán

ZIP/Postal Code

80230

Country

Mexico

Facility Name

Research Site

City

Guadalajara

ZIP/Postal Code

44670

Country

Mexico

Facility Name

Research Site

City

Guadalajara

ZIP/Postal Code

44676

Country

Mexico

Facility Name

Research Site

City

Minatitlán

ZIP/Postal Code

96730

Country

Mexico

Facility Name

Research Site

City

México

ZIP/Postal Code

06726

Country

Mexico

Facility Name

Research Site

City

Veracruz

ZIP/Postal Code

91900

Country

Mexico

Facility Name

Research Site

City

Xalapa

ZIP/Postal Code

91020

Country

Mexico

Facility Name

Research Site

City

Bellavista

ZIP/Postal Code

CALLAO 2

Country

Peru

Facility Name

Research Site

City

Ica

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

L17

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 01

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 1

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 27

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 31

Country

Peru

Facility Name

Research Site

City

Trujillo

ZIP/Postal Code

044

Country

Peru

Facility Name

Research Site

City

Cebu City

ZIP/Postal Code

6000

Country

Philippines

Facility Name

Research Site

City

Iloilo City

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Research Site

City

Iloilo

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Research Site

City

Quezon City

ZIP/Postal Code

1101

Country

Philippines

Facility Name

Research Site

City

Ciechanów

ZIP/Postal Code

06-400

Country

Poland

Facility Name

Research Site

City

Końskie

ZIP/Postal Code

26-200

Country

Poland

Facility Name

Research Site

City

Poznań

ZIP/Postal Code

60-355

Country

Poland

Facility Name

Research Site

City

Sochaczew

ZIP/Postal Code

96-500

Country

Poland

Facility Name

Research Site

City

Tczew

ZIP/Postal Code

83-110

Country

Poland

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

90-141

Country

Poland

Facility Name

Research Site

City

Cidra

ZIP/Postal Code

00739

Country

Puerto Rico

Facility Name

Research Site

City

Rio Grande

ZIP/Postal Code

00745

Country

Puerto Rico

Facility Name

Research Site

City

Rio Piedras

ZIP/Postal Code

00935

Country

Puerto Rico

Facility Name

Research Site

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

Research Site

City

San Juan

ZIP/Postal Code

00917

Country

Puerto Rico

Facility Name

Research Site

City

San Juan

ZIP/Postal Code

00921

Country

Puerto Rico

Facility Name

Research Site

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

Facility Name

Research Site

City

Toa Baja

ZIP/Postal Code

00949

Country

Puerto Rico

Facility Name

Research Site

City

Arad

ZIP/Postal Code

310017

Country

Romania

Facility Name

Research Site

City

Bucuresti

ZIP/Postal Code

010731

Country

Romania

Facility Name

Research Site

City

Bucuresti

ZIP/Postal Code

020475

Country

Romania

Facility Name

Research Site

City

Targu Mures

ZIP/Postal Code

540000

Country

Romania

Facility Name

Research Site

City

Timisoara

ZIP/Postal Code

300736

Country

Romania

Facility Name

Research Site

City

Arkhangelsk

ZIP/Postal Code

163001

Country

Russian Federation

Facility Name

Research Site

City

Barnaul

ZIP/Postal Code

656024

Country

Russian Federation

Facility Name

Research Site

City

Irkutsk

ZIP/Postal Code

664049

Country

Russian Federation

Facility Name

Research Site

City

Izhevsk

ZIP/Postal Code

426035

Country

Russian Federation

Facility Name

Research Site

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Facility Name

Research Site

City

Krasnoyarsk

ZIP/Postal Code

660062

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

105229

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

109263

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

129344

Country

Russian Federation

Facility Name

Research Site

City

Nizhniy Novgorod

ZIP/Postal Code

603076

Country

Russian Federation

Facility Name

Research Site

City

Nizhny Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Research Site

City

Perm

ZIP/Postal Code

614000

Country

Russian Federation

Facility Name

Research Site

City

Ryazan

ZIP/Postal Code

390027

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

191015

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

196601

Country

Russian Federation

Facility Name

Research Site

City

Ufa

ZIP/Postal Code

450000

Country

Russian Federation

Facility Name

Research Site

City

Ufa

ZIP/Postal Code

450005

Country

Russian Federation

Facility Name

Research Site

City

Ufa

ZIP/Postal Code

450071

Country

Russian Federation

Facility Name

Research Site

City

Volgograd

ZIP/Postal Code

404120

Country

Russian Federation

Facility Name

Research Site

City

Bratislava

ZIP/Postal Code

82606

Country

Slovakia

Facility Name

Research Site

City

Bratislava

ZIP/Postal Code

831 03

Country

Slovakia

Facility Name

Research Site

City

Kosice

ZIP/Postal Code

04011

Country

Slovakia

Facility Name

Research Site

City

Kralovsky Chlmec

ZIP/Postal Code

077 01

Country

Slovakia

Facility Name

Research Site

City

Nove Zamky

ZIP/Postal Code

940 34

Country

Slovakia

Facility Name

Research Site

City

Zvolen

ZIP/Postal Code

960 01

Country

Slovakia

Facility Name

Research Site

City

Almería

ZIP/Postal Code

04009

Country

Spain

Facility Name

Research Site

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Research Site

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Research Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Research Site

City

Kaohsiung City

ZIP/Postal Code

82445

Country

Taiwan

Facility Name

Research Site

City

Keelung

ZIP/Postal Code

20401

Country

Taiwan

Facility Name

Research Site

City

New Taipei

ZIP/Postal Code

220

Country

Taiwan

Facility Name

Research Site

City

New Taipei

ZIP/Postal Code

231

Country

Taiwan

Facility Name

Research Site

City

New Taipei

ZIP/Postal Code

23561

Country

Taiwan

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

402

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

0116

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10491

Country

Taiwan

Facility Name

Research Site

City

Taipei

Country

Taiwan

Facility Name

Research Site

City

TaoYuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Research Site

City

Bangkok

ZIP/Postal Code

10300

Country

Thailand

Facility Name

Research Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Research Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Research Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Research Site

City

Khon Kaen

ZIP/Postal Code

40000

Country

Thailand

Facility Name

Research Site

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Research Site

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Research Site

City

Antalya

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Research Site

City

Chernivtsi

ZIP/Postal Code

58002

Country

Ukraine

Facility Name

Research Site

City

Dnipro

ZIP/Postal Code

49005

Country

Ukraine

Facility Name

Research Site

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61002

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61058

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61103

Country

Ukraine

Facility Name

Research Site

City

Khmelnytsky

ZIP/Postal Code

29000

Country

Ukraine

Facility Name

Research Site

City

Kirovograd

ZIP/Postal Code

25006

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

01601

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

02125

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

04107

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

04114

Country

Ukraine

Facility Name

Research Site

City

Lutsk

ZIP/Postal Code

43005

Country

Ukraine

Facility Name

Research Site

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Research Site

City

Odesa

ZIP/Postal Code

65009

Country

Ukraine

Facility Name

Research Site

City

Rivne

ZIP/Postal Code

33027

Country

Ukraine

Facility Name

Research Site

City

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Research Site

City

Vinnytsia

ZIP/Postal Code

21029

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhya

ZIP/Postal Code

69001

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhya

ZIP/Postal Code

69068

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhya

ZIP/Postal Code

69118

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhya

ZIP/Postal Code

69600

Country

Ukraine

Facility Name

Research Site

City

Can Tho

ZIP/Postal Code

900000

Country

Vietnam

Facility Name

Research Site

City

Hanoi

ZIP/Postal Code

100000

Country

Vietnam

Facility Name

Research Site

City

Ho Chi Minh City

ZIP/Postal Code

700000

Country

Vietnam

Facility Name

Research Site

City

Hochiminh

ZIP/Postal Code

550000

Country

Vietnam

Facility Name

Research Site

City

Hochiminh

ZIP/Postal Code

700000

Country

Vietnam

Facility Name

Research Site

City

Hue

ZIP/Postal Code

530000

Country

Vietnam

12. IPD Sharing Statement

Citations:

PubMed Identifier

36005278

Citation

Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

Results Reference

derived

PubMed Identifier

34362786

Citation

Provenzano R, Szczech L, Leong R, Saikali KG, Zhong M, Lee TT, Little DJ, Houser MT, Frison L, Houghton J, Neff TB. Efficacy and Cardiovascular Safety of Roxadustat for Treatment of Anemia in Patients with Non-Dialysis-Dependent CKD: Pooled Results of Three Randomized Clinical Trials. Clin J Am Soc Nephrol. 2021 Aug;16(8):1190-1200. doi: 10.2215/CJN.16191020.

Results Reference

derived

PubMed Identifier

33568383

Citation

Fishbane S, El-Shahawy MA, Pecoits-Filho R, Van BP, Houser MT, Frison L, Little DJ, Guzman NJ, Pergola PE. Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study. J Am Soc Nephrol. 2021 Mar;32(3):737-755. doi: 10.1681/ASN.2020081150. Epub 2021 Feb 10.

Results Reference

derived

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5740C00001&attachmentIdentifier=e591fa4d-7259-4500-bf4c-783f4239fab9&fileName=D5740C00001_redacted_CSP_from_PRS.pdf&versionIdentifier=

Description

Related Info

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5740C00001&attachmentIdentifier=cf047ffd-547d-4bee-b970-58c377627038&fileName=D5740C00001_SAP-v3_Redacted_28-Sep-2018.pdf&versionIdentifier=

Description

Related Info

Learn more about this trial

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis

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Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis

Anemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial