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A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease

NCT01503736 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2020-01-13

No results posted yet for this study

Summary

The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).

Conditions

Interventions

DRUG

ferric citrate

0g/day ferric citrate capsule, TID for 56 days

DRUG

ferric citrate

4g/day ferric citrate capsule, TID for 56 days

DRUG

ferric citrate

6 g/day ferric citrate capsule, TID for 56 days

Sponsors & Collaborators

  • Panion & BF Biotech Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-06-30

Countries

  • Taiwan

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 NCT01503736 on ClinicalTrials.gov