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A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01191255
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : December 10, 2014
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

Study Description
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Brief Summary:
This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Kidney Failure Drug: ferric citrate, ca acetate, sevelamer carbonate, placebo Phase 3

Detailed Description:
This trial is a three-period, multicenter, safety and efficacy clinical trial. The first period is a two-week Washout Period, the second period is a 52-week randomized, open-label, active control Safety Assessment Period, and the third period is a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period in only the patients who were randomized to treatment with ferric citrate during the Safety Assessment Period. The primary objectives of this trial are to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with ESRD undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in the four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 441 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Three-Period, 58-Week Safety and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis
Study Start Date : October 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Safety

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active Control
PhosLo (calcium acetate) Renvela (sevelamer carbonate)
 Drug: ferric citrate, ca acetate, sevelamer carbonate, placebo
All intervention doses will be based on serum phosphorus levels and/or drug label requirements
Other Names:
  • PhosLo
  • Renvela
  • KRX-0502
  • Zerenex
Placebo Comparator: Placebo
Placebo
 Drug: ferric citrate, ca acetate, sevelamer carbonate, placebo
All intervention doses will be based on serum phosphorus levels and/or drug label requirements
Other Names:
  • PhosLo
  • Renvela
  • KRX-0502
  • Zerenex
Experimental: KRX-0502 (Ferric Citrate)
ferric citrate
 Drug: ferric citrate, ca acetate, sevelamer carbonate, placebo
All intervention doses will be based on serum phosphorus levels and/or drug label requirements
Other Names:
  • PhosLo
  • Renvela
  • KRX-0502
  • Zerenex


Outcome Measures
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Primary Outcome Measures :
  1. Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) [ Time Frame: 4 weeks ]
    Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.


Secondary Outcome Measures :
  1. Change in Mean Serum Ferritin From Baseline to Week 52 [ Time Frame: 52 weeks ]
  2. Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52) [ Time Frame: 52 weeks ]
  3. IV Iron Analysis [ Time Frame: 52 weeks ]
    Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52)

  4. ESA Analysis [ Time Frame: 52 weeks ]
    Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or non-pregnant, non-breast-feeding females
  2. Age ≥18 years
  3. On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening
  4. Serum phosphorus ≥6.0 mg/dL for study entry
  5. Taking less than 3-18 pills/day of current phosphate binder
  6. Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate
  7. Willing and able to give informed consent
  8. Life expectancy >1 year

Exclusion Criteria:

  1. Parathyroidectomy within six months prior to Screening
  2. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
  3. History of multiple drug allergies or intolerances
  4. History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
  5. Previous intolerance to oral ferric citrate
  6. Intolerance to oral iron-containing products
  7. Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
  8. Inability to tolerate oral drug intake
  9. Intolerance to calcium acetate and sevelamer carbonate
  10. Any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient
  11. Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
  12. Inability to cooperate with study personnel or history of noncompliance
  13. Unsuitable for this trial per Investigator's clinical judgment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191255


Locations
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Sponsors and Collaborators
Keryx Biopharmaceuticals
Investigators
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Study Chair: Julia B Lewis, MD Collaborative Study Group
Study Chair: Samuel Blumenthal, MD Collaborative Study Group
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01191255    
Obsolete Identifiers: NCT01510106
Other Study ID Numbers: KRX-0502-304
First Posted: August 30, 2010    Key Record Dates
Results First Posted: December 10, 2014
Last Update Posted: December 10, 2014
Last Verified: December 2014
Keywords provided by Keryx Biopharmaceuticals:
ESRD
end-stage renal disease
dialysis
hemodialysis
peritoneal dialysis
hemodialysis (HD)
 peritoneal dialysis (PD)
chronic renal insufficiency
phosphate binder
kidney failure
renal failure
Additional relevant MeSH terms:
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Renal Insufficiency
Hyperphosphatemia
Kidney Diseases
Urologic Diseases
Phosphorus Metabolism Disorders
 Metabolic Diseases
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action