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Ferric Citrate in Patients With End-Stage Renal Disease on Dialysis

This study has been completed.
Sponsor:
Collaborator:
Keryx Biopharmaceuticals
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01510106
First received: January 10, 2012
Last updated: March 14, 2013
Last verified: January 2012
History of Changes
  Purpose

The main purpose of this study is to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with end-stage renal disease undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period. Main eligibility criteria Males or non-pregnant, non-breast-feeding females, age 18 years, on thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening Visit (Visit 0), Serum phosphorus levels greater than or equal to 2.5 mg/dL and less than or equal to 8.0 mg/dL at Screening Visit (Visit 0), Serum phosphorus greater than or equal to 6.0 mg/dL during the Washout Period (Visits 2 or 3), taking 3 to 18 pills/day of calcium acetate, calcium carbonate, lanthanum carbonate, and/or sevelamer (carbonate or hydrochloride or equivalent sevelamer powder) or any other agent serving as a phosphate binder, or any combination and serum ferritin less than 1000 micrograms/L and less than TSAT 50% at the Screening Visit (Visit 0).


Condition Intervention Phase
ESRD
Dialysis
Hyperphosphatemia
 Drug: Calcium acetate, sevelamer carbonate
Drug: Ferric citrate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The primary efficacy outcome of this trial will be the effect of ferric citrate vs. placebo on the change in serum phosphorus from study-baseline (Visit 21, Week 52) to end of the Efficacy Assessment Period (Visit 25, Week 56). [ Time Frame: 56 weeks ] [ Designated as safety issue: Yes ]
    The primary efficacy outcome of this trial will be the effect of ferric citrate vs. placebo on the change in serum phosphorus from study-baseline (Visit 21, Week 52) to end of the Efficacy Assessment Period (Visit 25, Week 56). The primary efficacy variable will be analyzed via an ANCOVA model with treatment as the fixed effect and study-baseline as the covariate. Between-treatment differences will be estimated and two-sided 95% confidence intervals for the differences will be presented.


Enrollment: 4
Study Start Date: April 2011
Study Completion Date: March 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Control
Patients will return to their previously prescribed medication regimen
 Drug: Calcium acetate, sevelamer carbonate
per package insert
Experimental: Ferric Citrat
Patients will be prescribed 6 pills daily
 Drug: Ferric citrate
6 caplets daily to start. Titrate as needed to up to 12 per day.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males or non-pregnant, non-breast-feeding females
  2. Age greater than or equal to 18 years
  3. On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening Visit (Visit 0)
  4. Serum phosphorus levels greater than or equal to 2.5 mg/dL and less than or equal to 8.0 mg/dL at Screening Visit (Visit 0)
  5. Serum phosphorus greater than or equal to 6.0 mg/dL during the Washout Period (visits 2 or 3)
  6. Taking 3 to 18 pills per day (or 2-10 gm) of calcium acetate, calcium carbonate, lanthanum carbonate, and/or sevelamer (carbonate or hydrochloride or equivalent sevelamer powder) or any other agent serving as a phosphate binder, or any combination of these agents as reported by the patient at Screening Visit (Visit 0)
  7. Serum ferritin less than 1000 micrograms/L and TSAT less than 50% at the Screening Visit (Visit 0)
  8. Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate
  9. Willing and able to give informed consent
  10. Life expectancy greater than 1 year -

Exclusion Criteria:

  1. Parathyroidectomy within six months prior to Screening Visit (Visit 0)
  2. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
  3. Serum phosphorus levels greater than or equal to 10.0 mg/dL documented in the three monthly laboratories (done routinely in the dialysis unit) in all of the 3 months prior to the Screening Visit (Visit 0)
  4. Patients with baseline ferritin levels of greater than or equal to 1000 ng/mL and TSAT greater than or equal to 50% documented in the three monthly labs prior to the screening visit
  5. History of multiple drug allergies or intolerances
  6. History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
  7. Previous intolerance to oral ferric citrate
  8. Intolerance to oral iron-containing products
  9. Absolute requirement for oral iron therapy
  10. Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed)
  11. Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals 12 Psychiatric disorder that interferes with the patients ability to comply with the study protocol

13. Inability to tolerate oral drug intake 14. Intolerance to calcium acetate and sevelamer carbonate 15. Planned surgery or hospitalization during the trial (for example scheduled outpatient access surgery, eye laser surgery, etc allowed-Please contact CCC with any question) 16. 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 17. Receipt of any investigational drug within 30 days of Screening Visit (Visit 0) 18. Inability to cooperate with study personnel or history of noncompliance 19. Unsuitable for this trial per Investigators clinical judgment. -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510106

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Keryx Biopharmaceuticals
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01510106     History of Changes
Other Study ID Numbers: KRX-0502-304
Study First Received: January 10, 2012
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013