Trial | NCT01503736  Report issue

Title

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Definitive Phase III Study of the Effects of Ferric Citrate on Serum Phosphate in Subjects With End Stage Renal Disease

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ferric citrate ...

  • Study Participants

    183
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).
Study Started
Jun 30
2010
Primary Completion
Jun 30
2012
Last Update
Jan 13
2020

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

Placebo Placebo Comparator

4g/day Experimental

Ferric Citrate for a total daily dose of 4g

6g/day Experimental

Ferric Citrate for a total daily dose of 6g

Criteria 

Inclusion Criteria:

Age>18 years and has a diagnosis of ESRD
On a three-times per week hemodialysis regimen
On a stable dose of a phosphate-binding agent for at least one month prior to study entry.
If on vitamin D supplementation or calcitriol, must be on a stable dose for at least one month prior to study entry.
Hct >= 20%
Serum Ca level of 8 mg/dL to 10.5 mg/dL

Exclusion Criteria:

Is pregnant or lactating
Clinically significant GI disorder
Has tertiary hyperparathyroidism or is immediately post-operative from a parathyroidectomy (within the first 3 months post-op or the plasma Ca is <7 mg/dL)
ferritin>800 ng/mL
Unstable medical condition unsuitable for the study in the opinion of investigator
Has been treated with an investigational agent within 30 days of enrollment
Has a history of documented iron allergy or hemochromatosis
No Results Posted