Back to resultsKRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial) (COMPASS)
Primary Purpose
Chronic Kidney Diseases, Iron Deficiency Anemia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
KRX-0502
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases
Eligibility Criteria
Inclusion Criteria:
- Estimated glomerular filtration rate ≥20 mL/min and <60 mL/min
- Hgb ≥8.5 g/dL and ≤11.5 g/dL
- Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%
- Serum intact parathyroid hormone ≤600 pg/mL
Exclusion Criteria:
- Serum phosphate <3.0 mg/dL
- Intravenous (IV) iron administered within 4 weeks prior to Screening
- Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening
- Blood transfusion within 4 weeks prior to Screening
Sites / Locations
- Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC
- California Institute of Renal Research
- California Institute of Renal Research
- California Institute of Renal Research
- Denver Nephrologists, P.C.
- Miami Kidney Group
- Kidney and Hypertension Specialists of Miami, P.A.
- Southeastern Clinical Research Institute, LLC
- Renal Associates, LLC
- Research by Design, LLC
- South Mississippi Medical Research, LLC
- Clinical Research Consultants
- Sierra Nevada Nephrology Consultants
- Hypertension and Nephrology Association
- Division of Kidney/HTN Research
- Mountain Kidney & Hypertension Associates
- Metrolina Nephrology Associates, PA
- Eastern Nephrology Associates
- Southeastern Nephrology Associates
- Eastern Nephrology Associates
- Southeastern Nephrology
- Columbia Nephrology Associates, PA
- South Carolina Nephrology & Hypertension Center, Inc
- Nephrology Associates, P.C.
- Research Management, Inc.
- Research Management, Inc.
- P & I Clinical Research, LLC
- Clinical Advancement Center, PLLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
KRX-0502 1 tablet thrice daily (TID) with meals
KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
Outcomes
Primary Outcome Measures
Change From Baseline in Hemoglobin (Hgb) at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from a mixed model of repeated measures (MMRM), including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Secondary Outcome Measures
Change From Baseline in Hgb at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Time From Randomization to the First Increase From Baseline Hgb of at Least 0.5 Grams Per Deciliter (g/dL) During the Dose Titration Period
The Kaplan-Meier estimator of the survival function of time from randomization to the first increase from Baseline Hgb of at least 0.5 g/dL for each of the two starting dose treatment groups were obtained.
Change From Baseline in Transferrin Saturation (TSAT) at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Change From Baseline in TSAT at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Change From Baseline in Ferritin at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Change From Baseline in Ferritin at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Change From Baseline in Serum Phosphate at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Change From Baseline in Serum Phosphate at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Change From Baseline in eGFR at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Change From Baseline in Bicarbonate at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Change From Baseline in Bicarbonate at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope analysis of covariance (ANCOVA) model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.
Change From Baseline in iPTH at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Change From Baseline in C-terminal FGF23 at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.
Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Change From Baseline Scores for the Work Productivity and Activity Impairment (WPAI) Questionnaire Adapted for Anemia Associated With Chronic Kidney Disease (CKD) at Week 24: Work-associated Measures
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.
Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.
Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period
A hospitalization is defined as admission to the hospital.
Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period
A hospitalization is defined as admission to the hospital.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period
Treatment-emergent adverse events are defined as adverse events that began after the first administration of study medication or pre-existing conditions that worsened after the first dose of study medication.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03236246
Brief Title
KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)
Acronym
COMPASS
Official Title
Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keryx Biopharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of this study are to assess the long-term efficacy and safety of different dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects with non-dialysis dependent chronic kidney disease (CKD).
Detailed Description
This is a Phase 4, 48-week, randomized, open-label, multicenter clinical study comprised of 2 periods: a 24-week Dose Titration Period, followed by a 24-week Dose Maintenance Period. The study will consist of 12 scheduled clinic visits over a period of 48 weeks and additional visits as needed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Iron Deficiency Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
KRX-0502 1 tablet thrice daily (TID) with meals
Arm Title
Group 2
Arm Type
Experimental
Arm Description
KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
Intervention Type
Drug
Intervention Name(s)
KRX-0502
Other Intervention Name(s)
ferric citrate
Intervention Description
Oral ferric citrate with meals
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin (Hgb) at Week 24
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from a mixed model of repeated measures (MMRM), including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Time Frame
Baseline; Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Hgb at Week 48
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Time Frame
Baseline; Week 48
Title
Time From Randomization to the First Increase From Baseline Hgb of at Least 0.5 Grams Per Deciliter (g/dL) During the Dose Titration Period
Description
The Kaplan-Meier estimator of the survival function of time from randomization to the first increase from Baseline Hgb of at least 0.5 g/dL for each of the two starting dose treatment groups were obtained.
Time Frame
from Randomization to Week 24
Title
Change From Baseline in Transferrin Saturation (TSAT) at Week 24
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Time Frame
Baseline; Week 24
Title
Change From Baseline in TSAT at Week 48
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Time Frame
Baseline; Week 48
Title
Change From Baseline in Ferritin at Week 24
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Time Frame
Baseline; Week 24
Title
Change From Baseline in Ferritin at Week 48
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Time Frame
Baseline; Week 48
Title
Change From Baseline in Serum Phosphate at Week 24
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Time Frame
Baseline; up to Week 24
Title
Change From Baseline in Serum Phosphate at Week 48
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Time Frame
Baseline; Week 48
Title
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Time Frame
Baseline; Week 24
Title
Change From Baseline in eGFR at Week 48
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Time Frame
Baseline; Week 48
Title
Change From Baseline in Bicarbonate at Week 24
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Time Frame
Baseline; Week 24
Title
Change From Baseline in Bicarbonate at Week 48
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Time Frame
Baseline; Week 48
Title
Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope analysis of covariance (ANCOVA) model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.
Time Frame
Baseline; Week 24
Title
Change From Baseline in iPTH at Week 48
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Time Frame
Baseline; Week 48
Title
Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Time Frame
Baseline; Week 24
Title
Change From Baseline in C-terminal FGF23 at Week 48
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Time Frame
Baseline; Week 48
Title
Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.
Time Frame
Baseline; Week 24
Title
Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Time Frame
Baseline; Week 48
Title
Change From Baseline Scores for the Work Productivity and Activity Impairment (WPAI) Questionnaire Adapted for Anemia Associated With Chronic Kidney Disease (CKD) at Week 24: Work-associated Measures
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Time Frame
Baseline; Week 24
Title
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Time Frame
Baseline; Week 48
Title
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Time Frame
Baseline; Week 24
Title
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Time Frame
Baseline; Week 48
Title
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.
Time Frame
Baseline; Week 24
Title
Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48
Description
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.
Time Frame
Baseline; Week 48
Title
Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period
Description
A hospitalization is defined as admission to the hospital.
Time Frame
up to Week 48
Title
Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period
Description
A hospitalization is defined as admission to the hospital.
Time Frame
up to Week 48
Title
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period
Description
Treatment-emergent adverse events are defined as adverse events that began after the first administration of study medication or pre-existing conditions that worsened after the first dose of study medication.
Time Frame
up to Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Estimated glomerular filtration rate ≥20 mL/min and <60 mL/min
Hgb ≥8.5 g/dL and ≤11.5 g/dL
Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%
Serum intact parathyroid hormone ≤600 pg/mL
Exclusion Criteria:
Serum phosphate <3.0 mg/dL
Intravenous (IV) iron administered within 4 weeks prior to Screening
Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening
Blood transfusion within 4 weeks prior to Screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Keryx Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
California Institute of Renal Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
California Institute of Renal Research
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
California Institute of Renal Research
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Denver Nephrologists, P.C.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Miami Kidney Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Kidney and Hypertension Specialists of Miami, P.A.
City
Miami
State/Province
Florida
ZIP/Postal Code
33150
Country
United States
Facility Name
Southeastern Clinical Research Institute, LLC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States
Facility Name
Renal Associates, LLC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Research by Design, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60643
Country
United States
Facility Name
South Mississippi Medical Research, LLC
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39501
Country
United States
Facility Name
Clinical Research Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Sierra Nevada Nephrology Consultants
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Hypertension and Nephrology Association
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Division of Kidney/HTN Research
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Mountain Kidney & Hypertension Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Metrolina Nephrology Associates, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Eastern Nephrology Associates
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Southeastern Nephrology Associates
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Eastern Nephrology Associates
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Southeastern Nephrology
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Columbia Nephrology Associates, PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
South Carolina Nephrology & Hypertension Center, Inc
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Nephrology Associates, P.C.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Research Management, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Research Management, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
P & I Clinical Research, LLC
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)
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