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A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

NCT01074125 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2014-12-04

Study results available
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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.

Conditions

  • Hyperphosphatemia
  • End-Stage Renal Disease

Interventions

DRUG

ferric citrate

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

Sponsors & Collaborators

  • Collaborative Study Group (CSG)

    collaborator NETWORK

  • Keryx Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Julia B Lewis, MD · Collaborative Study Group (CSG)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01074125 on ClinicalTrials.gov