KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)
COMPASS
Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia
1 other identifier
interventional
206
1 country
28
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2017
Typical duration for phase_4
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2017
CompletedFirst Posted
Study publicly available on registry
August 1, 2017
CompletedStudy Start
First participant enrolled
August 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2019
CompletedResults Posted
Study results publicly available
March 12, 2021
CompletedMarch 12, 2021
March 1, 2021
2 years
July 26, 2017
February 2, 2021
March 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline; Week 24
Secondary Outcomes (27)
Change From Baseline in Hgb at Week 48
Baseline; Week 48
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
from Randomization to Week 24
Change From Baseline in Transferrin Saturation (TSAT) at Week 24
Baseline; Week 24
Change From Baseline in TSAT at Week 48
Baseline; Week 48
Change From Baseline in Ferritin at Week 24
Baseline; Week 24
- +22 more secondary outcomes
Study Arms (2)
Group 1
EXPERIMENTALKRX-0502 1 tablet thrice daily (TID) with meals
Group 2
EXPERIMENTALKRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC
Phoenix, Arizona, 85032, United States
California Institute of Renal Research
Chula Vista, California, 91910, United States
California Institute of Renal Research
El Centro, California, 92243, United States
California Institute of Renal Research
Poway, California, 92064, United States
Denver Nephrologists, P.C.
Denver, Colorado, 80230, United States
Miami Kidney Group
Miami, Florida, 33143, United States
Kidney and Hypertension Specialists of Miami, P.A.
Miami, Florida, 33150, United States
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, 30904, United States
Renal Associates, LLC
Columbus, Georgia, 31904, United States
Research by Design, LLC
Chicago, Illinois, 60643, United States
South Mississippi Medical Research, LLC
Gulfport, Mississippi, 39501, United States
Clinical Research Consultants
Kansas City, Missouri, 64111, United States
Sierra Nevada Nephrology Consultants
Reno, Nevada, 89511, United States
Hypertension and Nephrology Association
Eatontown, New Jersey, 07724, United States
Division of Kidney/HTN Research
Great Neck, New York, 11021, United States
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, 28801, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, 28207, United States
Eastern Nephrology Associates
Greenville, North Carolina, 27834, United States
Southeastern Nephrology Associates
Jacksonville, North Carolina, 28546, United States
Eastern Nephrology Associates
New Bern, North Carolina, 28562, United States
Southeastern Nephrology
Wilmington, North Carolina, 28401, United States
Columbia Nephrology Associates, PA
Columbia, South Carolina, 29203, United States
South Carolina Nephrology & Hypertension Center, Inc
Orangeburg, South Carolina, 29118, United States
Nephrology Associates, P.C.
Nashville, Tennessee, 37205, United States
Research Management, Inc.
Austin, Texas, 78751, United States
Research Management, Inc.
Austin, Texas, 78758, United States
P & I Clinical Research, LLC
Lufkin, Texas, 75904, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Keryx Medical Information
- Organization
- Keryx
Study Officials
- STUDY DIRECTOR
Medical Director
Keryx Biopharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2017
First Posted
August 1, 2017
Study Start
August 15, 2017
Primary Completion
August 30, 2019
Study Completion
September 27, 2019
Last Updated
March 12, 2021
Results First Posted
March 12, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share