KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD
A Phase 3 Study of KRX-0502 (Ferric Citrate) for the Treatment of Iron Deficiency Anemia (IDA) in Adult Subjects With Non-Dialysis Dependent (NDD) Chronic Kidney Disease
1 other identifier
interventional
234
1 country
36
Brief Summary
a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period").
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2014
Shorter than P25 for phase_3
36 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
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 11, 2014
CompletedFirst Posted
Study publicly available on registry
October 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
February 22, 2018
CompletedMarch 22, 2018
February 1, 2018
1.3 years
October 11, 2014
November 30, 2017
February 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period
Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.
Week 16
Secondary Outcomes (5)
Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline
Baseline and week 16
Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline
Baseline and week 16
Mean Change in Ferritin at the End of 16 Weeks Minus Baseline
Baseline and week 16
Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)
Week 16
Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline
Baseline and week 16
Study Arms (2)
KRX-0502 (ferric citrate)
EXPERIMENTAL1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
Placebo
PLACEBO COMPARATORMatching Placebo
Interventions
1 g ferric citrate containing approximately 210 mg of ferric iron
Eligibility Criteria
You may qualify if:
- Men and non-lactating women with negative serum pregnancy test (for women of child-bearing potential) at Screening
- Age ≥18 years
- CKD with Estimated Glomerular Filtration Rate (eGFR) \<60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation (with a limit of up to 20% of the target randomization of 230 subjects with eGFR \<15 mL/min)
- Patients who were intolerant of or have had an inadequate therapeutic response to oral iron supplements (in the opinion of the investigator)
- Hgb ≥ 9.0 g/dL and ≤11.5 g/dL at Screening
- Serum ferritin ≤200 ng/mL and Transferrin Saturation (TSAT) ≤25% at Screening
- Serum Intact Parathyroid Hormone (iPTH) ≤600 pg/mL at Screening
- Must consume a minimum of 2 meals per day
- Willing and able to give written informed consent
You may not qualify if:
- Serum phosphate \<3.5 mg/dL at Screening
- Liver enzymes (ALT/AST) \>X3 times upper limit of normal at Screening
- Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to Screening
- Evidence of acute kidney injury or requirement for dialysis within 12 weeks prior to Screening
- Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of Screening
- IV iron administered within 4 weeks prior to Screening
- Erythropoiesis-stimulating agent (ESA) administered within 4 weeks prior to Screening
- Blood transfusion within 4 weeks prior to Screening
- Receipt of any investigational drug within 4 weeks prior to Screening
- Cause of anemia other than iron deficiency or chronic kidney disease
- Malignancy (except non-melanoma skin cancer or disease-free for ≥2 years after curative therapy)
- History of hemochromatosis
- Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the PI)
- Subjects with known allergic reaction to previous oral iron therapy
- Previous intolerance to oral ferric citrate
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
AKDHC Medical Research Services, LLC
Phoenix, Arizona, 85027, United States
Southwest Kidney Institute
Tempe, Arizona, 85284, United States
California Renal Research
Glendale, California, 91204, United States
Southern California Medical Research Center
La Palma, California, 90623, United States
Academic Medical Research Institute, Inc
Los Angeles, California, 90022, United States
Apex Research of Riverside
Riverside, California, 92505, United States
Capital Nephrology Medical Group
Sacramento, California, 95825, United States
La Jolla Clinical Research, Inc
San Diego, California, 92103, United States
California Institute of Renal Research
San Diego, California, 92123, United States
Denver Nephrology
Denver, Colorado, 80230, United States
Creekside Medical Research
DeLand, Florida, 32123, United States
Riverside Clinical Research
Edgewater, Florida, 32132, United States
Pines Clinical Research, Inc
Pembroke Pines, Florida, 33028, United States
Kidney Care Associates, LLC
Augusta, Georgia, 30909, United States
Renal Physicians of Georgia, PC
Macon, Georgia, 31217, United States
Pacific Renal Research Institute
Meridian, Idaho, 83642, United States
Advanced Renal Care
Evergreen Park, Illinois, 60805, United States
Kansas Nephrology Research Institute
Wichita, Kansas, 67214, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808, United States
Western New England Renal & Transplant Associates
Springfield, Massachusetts, 01107, United States
Renaissance Renal Research
Detroit, Michigan, 48236, United States
Michigan Kidney Consultants, PC
Pontiac, Michigan, 48341, United States
Clinical Research Consultants
Kansas City, Missouri, 64111, United States
Lincoln Nephrology & Hypertension
Lincoln, Nebraska, 68105, United States
Sierra Nevada Nephrology Asoociates
Reno, Nevada, 89519, United States
Mountain Kidney & Hypertension Associates
Asheville, North Carolina, 28801, United States
Metrolina Nephrology
Charlotte, North Carolina, 28204, United States
Research Management, Inc
Austin, Texas, 78732, United States
Research Management, Inc.
Austin, Texas, 78758, United States
TAD Clinical Research
Lufkin, Texas, 75904, United States
Kidney & Hypertension Specialists
San Antonio, Texas, 78207, United States
Clinical Advancement Center
San Antonio, Texas, 78215, United States
San Antonio Kidney Disease Center
San Antonio, Texas, 78229, United States
Mendez Center for Clinical Research
Alexandria, Virginia, 22304, United States
Nephrology Associates of Northern VA, Inc.
Fairfax, Virginia, 22033, United States
Peninsula Kidney Associates
Hampton, Virginia, 23666, United States
Related Publications (1)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Keryx Medical Information
- Organization
- Keryx Biopharmaceuticals, Inc.
Study Officials
- STUDY CHAIR
Geoffrey Block, MD
Denver Nephrology
- STUDY CHAIR
Glenn Chertow, MD
Division of Nephrology at Stanford University School of Medicine
- STUDY CHAIR
Steven Fishbane, MD
Kidney Disease and Hypertension at North Shore University Hospital/Long Island Jewish Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2014
First Posted
October 20, 2014
Study Start
October 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
March 22, 2018
Results First Posted
February 22, 2018
Record last verified: 2018-02