Ferric Citrate for Chronic Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will be conducted to assess the safety and tolerability of ferric citrate in pediatric participants with hyperphosphatemia related to chronic kidney disease (CKD).
Will I have to stop taking my current medications?
If you are currently taking phosphate binders and your serum phosphorus levels are not above the specified limits, you will need to stop taking them for about 1 to 4 weeks before starting the trial.
Is ferric citrate safe for humans?
What makes the drug Ferric Citrate unique for treating chronic kidney disease?
Ferric Citrate is unique because it acts as both a phosphate binder and an iron replacement therapy, effectively controlling serum phosphate levels and improving iron parameters in patients with chronic kidney disease. This dual action helps manage hyperphosphatemia and iron deficiency anemia, reducing the need for additional iron supplements and erythropoietin stimulating agents.12346
What data supports the effectiveness of the drug Ferric Citrate for chronic kidney disease?
Who Is on the Research Team?
Chief Medical Officer
Principal Investigator
Akebia Therapeutics Inc.
Are You a Good Fit for This Trial?
This trial is for children with chronic kidney disease (CKD) who have high phosphate levels. They must have been on dialysis or have an eGFR <30 mL/min/1.73 m^2, weigh at least 40 kg, and not be pregnant. Participants need a history of CKD-related hyperphosphatemia for 3+ months and agree to birth control if applicable.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ferric citrate for 36 weeks at a starting dose based on body weight categories
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ferric Citrate
Ferric Citrate is already approved in United States for the following indications:
- 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
Who Is Running the Clinical Trial?
Keryx Biopharmaceuticals
Lead Sponsor