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A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

NCT01191255 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 441

Last updated 2014-12-10

Study results available
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Summary

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.

Conditions

Interventions

DRUG

ferric citrate, ca acetate, sevelamer carbonate, placebo

All intervention doses will be based on serum phosphorus levels and/or drug label requirements

Sponsors & Collaborators

  • Keryx Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Julia B Lewis, MD · Collaborative Study Group

  • Samuel Blumenthal, MD · Collaborative Study Group

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-01-31
Completion
2013-02-28

Countries

  • United States
  • Israel
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

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 NCT01191255 on ClinicalTrials.gov