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A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

Primary Purpose

CKD Anemia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Roxadustat

Placebo

About this trial

This is an interventional treatment trial for CKD Anemia focused on measuring anemia, chronic kidney disease (CKD), non-dialysis, Hemoglobin (Hb), End-Stage Renal Disease, erythropoeitin, ASP1517, erythropoeisis stimulating-agent, AZD9941

Eligibility Criteria

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

Inclusion Criteria:

Chronic kidney disease Stages 3, 4, or 5 and not receiving dialysis
Anemia qualified by measurements of hemoglobin values during screening
Additional blood work must be in a safe range for study entry
Body weight 45 to 160 kilograms (kg)
Willingness to use contraception if of child-bearing potential

Exclusion Criteria:

Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to study participation
More than 1 dose of intravenous iron within 12 weeks prior to study participation
Blood transfusion within 8 weeks prior to study participation
Active infection
Chronic liver disease
Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot
Uncontrolled blood pressure within 2 weeks prior to study participation
Renal cell carcinoma
History of malignancy, including multiple myeloma or other myelodysplastic syndrome
Chronic inflammatory disease that could impact red blood cell production
Any prior organ transplant or a scheduled organ transplantation
Anticipated elective surgery that is expected to lead to significant blood loss or anticipated elective heart procedure
Gastrointestinal bleeding
Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
Recent use of an investigational drug or treatment, or participation in an investigational study

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Roxadustat

Placebo

Arm Description

Participants will receive roxadustat tablets orally 3 times a week (TIW). The initial dose will be according to the tiered weight-based approach, with starting roxadustat doses of 70 milligrams (mg) TIW to participants weighing <70 kilograms (kg) and roxadustat doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) will be performed based upon regular measurement of Hb levels until the participant achieves central Hb value of ≥11.0 grams/deciliter (g/dL) and Hb increase from baseline (BL) of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level is reached, the participant will enter the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration will be up to 234.9 weeks.

Participants will receive roxadustat-matching placebo tablets orally TIW. The initial dose will be according to the tiered weight-based approach, with starting roxadustat-matching placebo doses of 70 mg TIW to participants weighing <70 kg and roxadustat-matching placebo doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) will be performed based upon regular measurement of Hb levels until the participant achieves central Hb value of ≥11.0 g/dL and Hb increase from BL of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level is reached, the participant will enter the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration will be up to 208.1 weeks.

Outcomes

Primary Outcome Measures

United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy

The change in Hb from baseline to the average level during the evaluation period (defined as Week 28 until Week 52) is reported. Hb values under the influence of a rescue therapy were not censored. The intermittent missing hemoglobin data were imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study drug.

Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy

The number of participants who achieved a Hb response at 2 consecutive visits at least 5 days apart during the first 24 weeks of treatment, without rescue therapy (that is, red blood cell [RBC] transfusion, erythropoiesis-stimulating agent [ESA], or intravenous [IV] iron) are reported. A Hb response is defined, using central laboratory values, as the following: Hb ≥11 g/dL and Hb increase from baseline by ≥1 g/dL in participants with baseline Hb >8 g/dL, or An increase in Hb by ≥2 g/dL in participants with baseline Hb ≤8.0 g/dL

Secondary Outcome Measures

Mean Change From Baseline in Hb Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy

For Ex-US submission only: Hb values under the influence of a rescue therapy were censored by mixed effect model of repeated measures (MMRM) for up to 6 weeks. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study drug.

Mean Change From Baseline in Hb Averaged Over Weeks 28 to 52 Regardless of Rescue Therapy in Participants With Baseline C-Reactive Protein (CRP) >Upper Limit of Normal (ULN)

Hb values under the influence of a rescue therapy were not censored in the analysis. The intermittent missing hemoglobin data were imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model, Monotone missing data were imputed by regression from its own treatment group. Baseline Hb was defined as the mean of up to 4 last central laboratory values prior to the first dose of study treatment.

Number (%) of Participants With Hb ≥10 g/dL Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy

Hb values under the influence of a rescue therapy were censored by Cochran-Mantel-Haenszel Test for up to 6 weeks. Responder was defined as: Hb ≥10.0 g/dL, which was based on central laboratory values.

Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 28

Baseline LDL cholesterol was defined as the last LDL cholesterol value prior to the first dose of study drug.

Rate of Change in eGFR From Baseline up to 12 Months (Linear Random Coefficient Model With Observed Data)

Progression of chronic kidney disease was measured by rate of change in eGFR over time adjusted by baseline eGFR, with censoring for chronic dialysis or kidney transplant, using random slope and intercept model. Least Square Mean of change from baseline at 1 year was derived based on a random slopes and intercepts model using all available eGFR values (1 baseline and all post-treatment values up to end of treatment period + 7 days or start of dialysis) adjusted on treatment, baseline Hb, baseline eGFR, geographical region, cardiovascular events history at Baseline (yes vs. no), time (continuous value), the interaction terms of baseline eGFR by time, baseline Hb by time, and treatment by time as fixed effects, with random effects of intercept and linear slope of time. All assessments collected after the start of stable dialysis or kidney transplant were excluded from the analysis.

Number of Participants Who Received Blood/RBC Transfusion in the First 52 Weeks of Treatment

Participants with any use of blood/RBC transfusion were reported.

Number (%) of Participants Who Received Rescue Therapy in the First 24 Weeks and in the First 52 Weeks of Treatment

Rescue therapy included any use of RBC transfusion, ESA, or IV iron.

Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 12 to 28

The SF-36 V2 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The physical functioning subscore and vitality subscore are reported. The scores ranged from 0 (worst) to 100 (Best). A higher score indicates a general improvement of life quality or well-being. Baseline score was defined as the last physical functioning value or vitality value, as applicable, prior to the first dose of study drug.

Number (%) of Participants Who Experienced Exacerbation of Hypertension

Exacerbation of hypertension was defined as an increase from baseline of ≥20 millimeter of mercury (mmHg) in systolic blood pressure (sBP) and sBP ≥170 mmHg or an increase from baseline of ≥15 mmHg in diastolic blood pressure (dBP) and dBP ≥110 mmHg.

Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 20 to 28

Baseline MAP was defined as the last MAP value prior to the first dose of study drug.

Full Information

NCT ID

NCT01750190

First Posted

December 11, 2012

Last Updated

September 1, 2021

Sponsor

FibroGen

Collaborators

Astellas Pharma Europe B.V., AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01750190

Brief Title

A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

Official Title

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

November 5, 2012 (Actual)

Primary Completion Date

September 24, 2018 (Actual)

Study Completion Date

September 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

FibroGen

Collaborators

Astellas Pharma Europe B.V., AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.

Detailed Description

There is a screening period of up to 6 weeks, a variable treatment period for individual participants. In order to complete the treatment period simultaneously for all study participants, the minimum treatment duration may be less than 52 weeks, with a maximum treatment duration of up to 3 years after the last participant is randomized, and a post-treatment follow-up period of 4 weeks. Participants who prematurely discontinued from treatment will be expected to complete the Early Termination (ET) and End of Study (EOS) visits. Such participants will be considered non-completers, but they will be expected to participate in long-term follow-up (LTFU) for cardiovascular events (CV) of interest, vital status, and hospitalizations until overall study closure unless the participant withdrew consent for this LTFU data collection. Participants were randomized in a 2:1 ratio to receive either roxadustat or placebo in a double-blind manner.

6. Conditions and Keywords

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

CKD Anemia

Keywords

anemia, chronic kidney disease (CKD), non-dialysis, Hemoglobin (Hb), End-Stage Renal Disease, erythropoeitin, ASP1517, erythropoeisis stimulating-agent, AZD9941

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

922 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Roxadustat

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Roxadustat

Other Intervention Name(s)

FG-4592, ASP1517, AZD9941

Intervention Description

Oral tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral tablets

Primary Outcome Measure Information:

Title

United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy

Description

Time Frame

Baseline (Day 1, Week 0), Weeks 28 to 52

Title

Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy

Description

Time Frame

Baseline up to Week 24

Secondary Outcome Measure Information:

Title

Mean Change From Baseline in Hb Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy

Description

Time Frame

Baseline (Day 1, Week 0), Weeks 28 to 36

Title

Mean Change From Baseline in Hb Averaged Over Weeks 28 to 52 Regardless of Rescue Therapy in Participants With Baseline C-Reactive Protein (CRP) >Upper Limit of Normal (ULN)

Description

Time Frame

Baseline (Day 1, Week 0), Weeks 28 to 52

Title

Number (%) of Participants With Hb ≥10 g/dL Averaged Over Weeks 28 to 36 With Censoring for Rescue Therapy

Description

Time Frame

Weeks 28 to 36

Title

Mean Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol Averaged Over Weeks 12 to 28

Description

Baseline LDL cholesterol was defined as the last LDL cholesterol value prior to the first dose of study drug.

Time Frame

Baseline (Day 1, Week 0), Weeks 12 to 28

Title

Rate of Change in eGFR From Baseline up to 12 Months (Linear Random Coefficient Model With Observed Data)

Description

Time Frame

Baseline, Month 12

Title

Number of Participants Who Received Blood/RBC Transfusion in the First 52 Weeks of Treatment

Description

Participants with any use of blood/RBC transfusion were reported.

Time Frame

Baseline up to Week 52

Title

Number (%) of Participants Who Received Rescue Therapy in the First 24 Weeks and in the First 52 Weeks of Treatment

Description

Rescue therapy included any use of RBC transfusion, ESA, or IV iron.

Time Frame

Baseline (Day 1, Week 0) up to Week 24 and up to Week 52

Title

Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 12 to 28

Description

Time Frame

Baseline (Day 1, Week 0), Weeks 12 to 28

Title

Number (%) of Participants Who Experienced Exacerbation of Hypertension

Description

Time Frame

Baseline up to Week 52

Title

Mean Change From Baseline in Mean Arterial Pressure (MAP) Averaged Over Weeks 20 to 28

Description

Baseline MAP was defined as the last MAP value prior to the first dose of study drug.

Time Frame

Baseline, Weeks 20 to 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic kidney disease Stages 3, 4, or 5 and not receiving dialysis Anemia qualified by measurements of hemoglobin values during screening Additional blood work must be in a safe range for study entry Body weight 45 to 160 kilograms (kg) Willingness to use contraception if of child-bearing potential Exclusion Criteria: Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to study participation More than 1 dose of intravenous iron within 12 weeks prior to study participation Blood transfusion within 8 weeks prior to study participation Active infection Chronic liver disease Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot Uncontrolled blood pressure within 2 weeks prior to study participation Renal cell carcinoma History of malignancy, including multiple myeloma or other myelodysplastic syndrome Chronic inflammatory disease that could impact red blood cell production Any prior organ transplant or a scheduled organ transplantation Anticipated elective surgery that is expected to lead to significant blood loss or anticipated elective heart procedure Gastrointestinal bleeding Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) Recent use of an investigational drug or treatment, or participation in an investigational study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Eisner, MD, MPH

Organizational Affiliation

FibroGen

Official's Role

Study Chair

Facility Information:

Facility Name

Investigational Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Investigational Site

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85284

Country

United States

Facility Name

Investigational Site

City

Alhambra

State/Province

California

ZIP/Postal Code

91801

Country

United States

Facility Name

Investigational Site

City

Chula Vista

State/Province

California

ZIP/Postal Code

91910

Country

United States

Facility Name

Investigational Site

City

Inglewood

State/Province

California

ZIP/Postal Code

90301

Country

United States

Facility Name

Investigational Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Investigational Site

City

La Palma

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

Investigational Site

City

Lynwood

State/Province

California

ZIP/Postal Code

90262

Country

United States

Facility Name

Investigational Site

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Investigational Site

City

Paramount

State/Province

California

ZIP/Postal Code

90723

Country

United States

Facility Name

Investigational Site

City

Riverside

State/Province

California

ZIP/Postal Code

92503

Country

United States

Facility Name

Investigational Site

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

Investigational Site

City

San Dimas

State/Province

California

ZIP/Postal Code

91773

Country

United States

Facility Name

Investigational Site

City

Whittier

State/Province

California

ZIP/Postal Code

90603

Country

United States

Facility Name

Investigational Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Investigational Site

City

Cutler Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Facility Name

Investigational Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Facility Name

Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33122

Country

United States

Facility Name

Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33150

Country

United States

Facility Name

Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Investigational Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33028

Country

United States

Facility Name

Investigational Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Investigational Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

Investigational Site

City

Caldwell

State/Province

Idaho

ZIP/Postal Code

83605

Country

United States

Facility Name

Investigational Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21218

Country

United States

Facility Name

Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Investigational Site

City

Flint

State/Province

Michigan

ZIP/Postal Code

48503

Country

United States

Facility Name

Investigational Site

City

Flint

State/Province

Michigan

ZIP/Postal Code

48532

Country

United States

Facility Name

Investigational Site

City

Pontiac

State/Province

Michigan

ZIP/Postal Code

48341

Country

United States

Facility Name

Investigational Site

City

Roseville

State/Province

Michigan

ZIP/Postal Code

48066

Country

United States

Facility Name

Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Investigational Site

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Facility Name

Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

Investigational Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Investigational Site

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Investigational Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

Investigational Site

City

Rocky Mount

State/Province

North Carolina

ZIP/Postal Code

27804

Country

United States

Facility Name

Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Investigational Site

City

Beaver

State/Province

Pennsylvania

ZIP/Postal Code

15009

Country

United States

Facility Name

Investigational Site

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

Investigational Site

City

Sumter

State/Province

South Carolina

ZIP/Postal Code

29150

Country

United States

Facility Name

Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Investigational Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76015

Country

United States

Facility Name

Investigational Site

City

Corsicana

State/Province

Texas

ZIP/Postal Code

75110

Country

United States

Facility Name

Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Investigational Site

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22033

Country

United States

Facility Name

Investigational Site

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

Investigational Site

City

Ciudad Evita

State/Province

Buenos Aires

ZIP/Postal Code

B1178IFA

Country

Argentina

Facility Name

Investigational Site

City

Moron

State/Province

Buenos Aires

ZIP/Postal Code

B1708DPN

Country

Argentina

Facility Name

Investigational Site

City

González Catán

State/Province

Provincia De Buenos Aires

ZIP/Postal Code

B1759LTF

Country

Argentina

Facility Name

Investigational Site

City

Junin

State/Province

Provincia De Buenos Aires

ZIP/Postal Code

B6000GMA

Country

Argentina

Facility Name

Investigational Site

City

Pergamino

State/Province

Provincia De Buenos Aires

ZIP/Postal Code

B2700CPM

Country

Argentina

Facility Name

Investigational Product

City

Villa Domínico

State/Province

Provincia De Buenos Aires

ZIP/Postal Code

B1874GBA

Country

Argentina

Facility Name

Investigational Site

City

Ciudad de Cordoba

State/Province

Provincia De Cordoba

ZIP/Postal Code

X5002HWE

Country

Argentina

Facility Name

Investigational Site

City

Buenos Aires

ZIP/Postal Code

B1852FZD

Country

Argentina

Facility Name

Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1425BPJ

Country

Argentina

Facility Name

Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1429BWN

Country

Argentina

Facility Name

Investigational Site

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Investigational Site

City

Cordoba

ZIP/Postal Code

X5002AOQ

Country

Argentina

Facility Name

Investigational site

City

Cordoba

ZIP/Postal Code

X5016KET

Country

Argentina

Facility Name

Investigational Site

City

Corrientes

ZIP/Postal Code

3400

Country

Argentina

Facility Name

Investigational Site

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Investigational Site

City

Salta

ZIP/Postal Code

A4402BGJ

Country

Argentina

Facility Name

Investigational Site

City

Santa Fe

ZIP/Postal Code

3000

Country

Argentina

Facility Name

Investigational Site

City

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

Country

Australia

Facility Name

Investigational Site

City

Gosford

ZIP/Postal Code

2250

Country

Australia

Facility Name

Investigational Site

City

Hobart

ZIP/Postal Code

7000

Country

Australia

Facility Name

Investigational Site

City

Launceston

ZIP/Postal Code

7250

Country

Australia

Facility Name

Investigational Site

City

Melbourne

ZIP/Postal Code

3004

Country

Australia

Facility Name

Investigational Site

City

New Lambton Heights

ZIP/Postal Code

2305

Country

Australia

Facility Name

Investigational Site

City

Randwick

ZIP/Postal Code

2031

Country

Australia

Facility Name

Investigational Site

City

Temuco

State/Province

Region De La Araucania

ZIP/Postal Code

4781151

Country

Chile

Facility Name

Investigational Site

City

Santiago

State/Province

Region Metropolitana

ZIP/Postal Code

8431657

Country

Chile

Facility Name

Investigational Site

City

Barranquilla

State/Province

Atlantico

Country

Colombia

Facility Name

Investigational Site

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Investigational Site

City

Hong Kong

State/Province

Pokfulam

Country

Hong Kong

Facility Name

Investigational Site

City

Chai Wan

Country

Hong Kong

Facility Name

Investigational Site

City

Shatin

ZIP/Postal Code

852

Country

Hong Kong

Facility Name

Investigational Site

City

Tai Po

Country

Hong Kong

Facility Name

Investigational Site

City

Anyang-Si

State/Province

Gyeonggi-Do

ZIP/Postal Code

431-796

Country

Korea, Republic of

Facility Name

Investigational Site

City

Goyang-Si

State/Province

Gyeonggi-Do

ZIP/Postal Code

410-719

Country

Korea, Republic of

Facility Name

Investigational Site

City

Guri-Si

State/Province

Gyeonggi-Do

ZIP/Postal Code

471-701

Country

Korea, Republic of

Facility Name

Investigational Site

City

Seongnam-Si

State/Province

Gyeonggi-Do

ZIP/Postal Code

463-712

Country

Korea, Republic of

Facility Name

Investigational Site

City

Busan

ZIP/Postal Code

614-735

Country

Korea, Republic of

Facility Name

Investigational Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Investigational Site

City

Seoul

ZIP/Postal Code

130-872

Country

Korea, Republic of

Facility Name

Investigational Site

City

Seoul

ZIP/Postal Code

133-791

Country

Korea, Republic of

Facility Name

Investigational Site

City

Seoul

ZIP/Postal Code

134-727

Country

Korea, Republic of

Facility Name

Investigational Site

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

Investigational Site

City

Seoul

ZIP/Postal Code

143-729

Country

Korea, Republic of

Facility Name

Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

Investigational Site

City

Alor Setar

ZIP/Postal Code

05460

Country

Malaysia

Facility Name

Investigational Site

City

Kajang

ZIP/Postal Code

43000

Country

Malaysia

Facility Name

Investigational Site

City

Kuala Lumpur

ZIP/Postal Code

50586

Country

Malaysia

Facility Name

Investigational Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Investigational Site

City

Kuching

ZIP/Postal Code

93586

Country

Malaysia

Facility Name

Investigational Site

City

Pulau Pinang

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

Investigational Site

City

Sungai Petani

ZIP/Postal Code

080000

Country

Malaysia

Facility Name

Investigational Site

City

Taiping

ZIP/Postal Code

34000

Country

Malaysia

Facility Name

Investigational Site

City

Mexico City

State/Province

Distrito Federal

ZIP/Postal Code

06100

Country

Mexico

Facility Name

Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44280

Country

Mexico

Facility Name

Investigational Site

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64000

Country

Mexico

Facility Name

Investigational Site

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97133

Country

Mexico

Facility Name

Investigational Site

City

Aguascalientes

ZIP/Postal Code

20128

Country

Mexico

Facility Name

Investigational Site

City

San Luis Potosi

ZIP/Postal Code

78240

Country

Mexico

Facility Name

Investigational Site

City

Auckland

Country

New Zealand

Facility Name

Investigational Site

City

Hamilton

ZIP/Postal Code

3240

Country

New Zealand

Facility Name

Investigational Site

City

Tauranga

ZIP/Postal Code

3143

Country

New Zealand

Facility Name

Investigational Site

City

Bellavista

State/Province

Callao

ZIP/Postal Code

Callao 2

Country

Peru

Facility Name

Investigational Site

City

San Martin de Porres

State/Province

Lima

ZIP/Postal Code

Lima 31

Country

Peru

Facility Name

Investigational site

City

Lima

ZIP/Postal Code

Lima 13

Country

Peru

Facility Name

Investigational Site

City

Lima

ZIP/Postal Code

Lima 1

Country

Peru

Facility Name

Investigational Site

City

Dasmarinas

State/Province

Cavite

ZIP/Postal Code

4114

Country

Philippines

Facility Name

Investigational Site

City

Davao City

State/Province

Davao

ZIP/Postal Code

8000

Country

Philippines

Facility Name

Investigational site

City

Pasig

Country

Philippines

Facility Name

Investigational Site

City

Quezon City

ZIP/Postal Code

1100

Country

Philippines

Facility Name

Investigational Site

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Investigational Site

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

Investigational Site

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

Investigational Site

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Investigational Site

City

Singapore

ZIP/Postal Code

768828

Country

Singapore

Facility Name

Investigational Site

City

Singapore

Country

Singapore

Facility Name

Investigational Site

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Investigational Site

City

Hualien City

ZIP/Postal Code

970

Country

Taiwan

Facility Name

Investigational Site

City

Kaohsiung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Investigational Site

City

Kaohsiung

ZIP/Postal Code

81362

Country

Taiwan

Facility Name

Investigational Site

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Investigational Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Investigational Site

City

Taichung

ZIP/Postal Code

433

Country

Taiwan

Facility Name

Investigational Site

City

Tainan City

ZIP/Postal Code

433

Country

Taiwan

Facility Name

Investigational Site

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Investigational Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Investigational Site

City

Taipei

ZIP/Postal Code

110

Country

Taiwan

Facility Name

Investigational Site

City

Taipei

ZIP/Postal Code

11490

Country

Taiwan

Facility Name

Investigational Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Investigational Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Yes

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

33732977

Citation

Coyne DW, Roger SD, Shin SK, Kim SG, Cadena AA, Moustafa MA, Chan TM, Besarab A, Chou W, Bradley C, Eyassu M, Leong R, Lee TT, Saikali KG, Szczech L, Yu KP. Roxadustat for CKD-related Anemia in Non-dialysis Patients. Kidney Int Rep. 2020 Dec 5;6(3):624-635. doi: 10.1016/j.ekir.2020.11.034. eCollection 2021 Mar.

Results Reference

derived

Learn more about this trial

A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

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A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

CKD 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