CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 154 enrolled
Drug / intervention
ferric citratedrug
Likely dose
ferric citrate 8 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01074125
NCT01074125Phase 3Completed

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

Keryx Biopharmaceuticals·interventional·Posted Feb 24, 2010·Updated Dec 4, 2014

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2010
Enrollment StartMay 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.4 years ago

Interventions

ferric citratedrug

1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days