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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01503736

Enrollment

183

Registered

2012-01-04

Start date

2010-06-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, ESRD, Hyperphosphatemia

Keywords

Kidney Diseases, Kidney Failure, Chronic, Hyperphosphatemia, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency, Phosphorus Metabolism Disorders

Brief 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).

Interventions

DRUGferric citrate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in serum phosphorus at Day 56 as compared to baseline	Day 56

Secondary

Measure	Time frame
Change in serum phosphorus at Day 28 as compared to baseline	Day 28
Change in Ca x P product at Day 56 compared to baseline	Day 56
Change in Ca x P product at Day 28 compared to baseline	Day 28
Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56	Day 56
Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28	Day 28

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026