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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01191255
First received: August 26, 2010
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Hyperphosphatemia
Kidney Failure
Drug: ferric citrate, ca acetate, sevelamer carbonate, placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Keryx Biopharmaceuticals:

Primary Outcome Measures:
  • Serum Phosphorus Levels [ Time Frame: Measured at each visit over 58 weeks ] [ Designated as safety issue: No ]
    Serum phosphorus evaluated approximately weekly for 7 visits, then bi-weekly for 5 visits, then monthly for 10 visits. For patients assigned to ferric citrate, there will be an additional 4 visits of serum phosphorus monitoring.


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Measured over 58 weeks ] [ Designated as safety issue: Yes ]
    Adverse events will be measured at each visit once consent form is signed by patient.

  • Concomitant Medication Changes [ Time Frame: Measured over 58 weeks ] [ Designated as safety issue: Yes ]
    Concomitant medication changes will be measured at each visit starting from screening.

  • Vitals [ Time Frame: Measured over 58 weeks ] [ Designated as safety issue: Yes ]
    Vitals will be measured at each visit starting with screening.

  • Blood Laboratory Results [ Time Frame: Measured over 58 weeks ] [ Designated as safety issue: Yes ]
    Blood laboratory results, beyond serum phosphorus and calcium levels, will be measured at specified visits throughout the trial.


Enrollment: 441
Study Start Date: October 2010
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Control
Patients may receive either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during the 52-week Safety Assessment Period.
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
Patients assigned to KRX-0502 (ferric citrate) during the 52-week Safety Assessment Period will be randomized to continue to receive ferric citrate or a placebo for the 4-week Efficacy Assessment Period.
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)
Patients assigned to KRX-0502 (ferric citrate) during the 52-week Safety Assessment Period will be randomized to continue to receive ferric citrate or a placebo for the 4-week Efficacy Assessment Period.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191255

  Show 52 Study Locations
Sponsors and Collaborators
Keryx Biopharmaceuticals
Investigators
Study Chair: Julia B Lewis, MD Collaborative Study Group
Study Chair: Samuel Blumenthal, MD Collaborative Study Group
  More Information

Additional Information:
No publications provided

Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01191255     History of Changes
Other Study ID Numbers: KRX-0502-304
Study First Received: August 26, 2010
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health

Keywords provided by Keryx Biopharmaceuticals:
ESRD
end-stage renal disease
dialysis
hemodialysis
peritoneal dialysis
HD
PD
chronic renal insufficiency
phosphate binder
kidney failure
renal failure

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

ClinicalTrials.gov processed this record on October 19, 2014