NCT01503736

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 2, 2012

Last Update Submit

January 9, 2020

Conditions

HyperphosphatemiaEnd Stage Renal DiseaseESRD

Keywords

Kidney DiseasesKidney Failure, ChronicHyperphosphatemiaUrologic DiseasesRenal Insufficiency, ChronicRenal InsufficiencyPhosphorus Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

  • Change in serum phosphorus at Day 56 as compared to baseline

    Day 56

Secondary Outcomes (5)

  • 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: ferric citrate

4g/day

EXPERIMENTAL

Ferric Citrate for a total daily dose of 4g

Drug: ferric citrate

6g/day

EXPERIMENTAL

Ferric Citrate for a total daily dose of 6g

Drug: ferric citrate

Interventions

ferric citrateDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Division of Nephrology, Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

Location

Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital

New Taipei City, Taiwan

Location

Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital

Taichung, Taiwan

Location

Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Related Publications (2)

  • Lee CT, Wu IW, Chiang SS, Peng YS, Shu KH, Wu MJ, Wu MS. Effect of oral ferric citrate on serum phosphorus in hemodialysis patients: multicenter, randomized, double-blind, placebo-controlled study. J Nephrol. 2015 Feb;28(1):105-13. doi: 10.1007/s40620-014-0108-6. Epub 2014 May 20.

    PMID: 24840781RESULT

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PMID: 40576086DERIVED

MeSH Terms

Conditions

HyperphosphatemiaKidney Failure, ChronicKidney DiseasesUrologic DiseasesRenal Insufficiency, ChronicRenal InsufficiencyPhosphorus Metabolism Disorders

Interventions

ferric citrate

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 4, 2012

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

TW(5)