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Completed

NCT Number: NCT01503736

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

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).

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Key information

Conditions

Hyperphosphatemia Chronic Disease Disease Attributes ESRD End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferric citrate

Drug

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

Primary outcomes

  1. Change in serum phosphorus at Day 56 as compared to baseline

    Time frame: Day 56

Secondary outcomes

  1. Change in serum phosphorus at Day 28 as compared to baseline

    Time frame: Day 28

  2. Change in Ca x P product at Day 56 compared to baseline

    Time frame: Day 56

  3. Change in Ca x P product at Day 28 compared to baseline

    Time frame: Day 28

  4. Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56

    Time frame: Day 56

  5. Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28

    Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Panion & BF Biotech Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
First posted
Jan 4, 2012
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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