At a glance
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A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) Following a Two-Week Washout Period
In Brief
A Phase 3 clinical trial evaluating ferric citrate for Hyperphosphatemia and End-Stage Renal Disease. Completed, enrolled 154 participants across 16 sites in 2 countries.
Detailed Summary
This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.
Study Details
Timeline
Interventions
1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days