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A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

NCT00648167 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2017-04-04

Study results available
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Summary

This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.

Conditions

  • Hyperphosphatemia
  • End-stage Renal Disease

Interventions

DRUG

ferric citrate

ferric citrate will be provided as a 375mg capsule. Dosing and frequency are dependent on patient's serum phosphorus levels. Dosing will occur over the 28-day study.

Sponsors & Collaborators

  • Collaborative Study Group (CSG)

    collaborator NETWORK

  • Keryx Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Julia B Lewis, MD · Collaborative Study Group at the Nephrology Clinical Trials Center, Vanderbilt University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

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 NCT00648167 on ClinicalTrials.gov