A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
Recruiting in Palo Alto (17 mi)
+55 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Keryx Biopharmaceuticals
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.
Research Team
JB
Julia B Lewis, MD
Principal Investigator
Collaborative Study Group
SB
Samuel Blumenthal, MD
Principal Investigator
Collaborative Study Group
Eligibility Criteria
Inclusion Criteria
Males or non-pregnant, non-breast-feeding females
Age ≥18 years
On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening
See 5 more
Treatment Details
Interventions
- Ca Acetate (Drug)
- Ferric Citrate (Iron-Based Phosphate Binder)
- Placebo (Drug)
- Sevelamer Carbonate (Drug)
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: KRX-0502 (Ferric Citrate)Experimental Treatment1 Intervention
ferric citrate
Group II: Active ControlActive Control1 Intervention
PhosLo (calcium acetate) Renvela (sevelamer carbonate)
Group III: PlaceboPlacebo Group1 Intervention
Placebo
Ferric Citrate is already approved in United States for the following indications:
🇺🇸 Approved in United States as Auryxia for:
- Hyperphosphatemia in patients with chronic kidney disease on dialysis
- Iron-deficiency anemia in patients with chronic kidney disease not on dialysis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Apex Research of RiversideRiverside, CA
Nephrology Specialists, PCMichigan City, IN
Pines Clinical Research, Inc.Pembroke Pines, FL
Atlanta Nephrology Referral CenterDecatur, GA
More Trial Locations
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Who Is Running the Clinical Trial?
Keryx Biopharmaceuticals
Lead Sponsor
Trials
21
Patients Recruited
4,200+