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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Panion & BF Biotech Inc.
ClinicalTrials.gov Identifier:
NCT01503736
First received: January 2, 2012
Last updated: January 3, 2012
Last verified: January 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Hyperphosphatemia
End Stage Renal Disease
ESRD
 Drug: ferric citrate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Panion & BF Biotech Inc.:

Primary Outcome Measures:
  • Change in serum phosphorus at Day 56 as compared to baseline [ Time Frame: Day 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum phosphorus at Day 28 as compared to baseline [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Change in Ca x P product at Day 56 compared to baseline [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
  • Change in Ca x P product at Day 28 compared to baseline [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56 [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
  • Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: June 2010
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: ferric citrate
0g/day ferric citrate capsule, TID for 56 days
Experimental: 4g/day
Ferric Citrate for a total daily dose of 4g
 Drug: ferric citrate
4g/day ferric citrate capsule, TID for 56 days
Experimental: 6g/day
Ferric Citrate for a total daily dose of 6g
 Drug: ferric citrate
6 g/day ferric citrate capsule, TID for 56 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503736

Locations
China
Beijing, China
Shanghai, China
Taiwan
Kaohsiung, Taiwan
Keelung, Taiwan
Taichung, Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Panion & BF Biotech Inc.
  More Information

No publications provided

Responsible Party: Panion & BF Biotech Inc.
ClinicalTrials.gov Identifier: NCT01503736     History of Changes
Other Study ID Numbers: PNC00301
Study First Received: January 2, 2012
Last Updated: January 3, 2012
Health Authority: United States: Institutional Review Board
Taiwan : Food and Drug Administration

Keywords provided by Panion & BF Biotech Inc.:
Kidney Diseases
Kidney Failure, Chronic
Hyperphosphatemia
Urologic Diseases
 Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorders

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
 Citric Acid
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013