Text Size

A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01554982
First received: March 12, 2012
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term Safety Extension 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 Keryx Biopharmaceuticals:

Primary Outcome Measures:
  • Safety Parameters [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    Safety will be assessed by recording and monitoring AEs, SAEs, and sequential laboratory data. Rates of adverse events will be summarized by organ system class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate).


Secondary Outcome Measures:
  • Efficacy Parameters [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
    The changes from baseline in laboratory parameters (including serum phosphorus, TSAT, ferritin, hemoglobin, and hematocrit) over time and at study completion will also be summarized.


Estimated Enrollment: 350
Study Start Date: August 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferric Citrate Drug: ferric citrate
Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.

  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 who participated in the Safety Assessment Period, and if eligible, the Efficacy Assessment Period of Study KRX-0502-304
  2. Willing and able to give informed consent

Exclusion Criteria:

  1. Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in first period
  2. Any subject in Study KRX-0502-304 who early terminated from the trial
  3. Any subject who participated in Study KRX-0502-304 but declined
  4. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
  5. History of malignancy in the last five years
  6. Previous intolerance to KRX-0502 (ferric citrate)
  7. Intolerance to oral iron-containing products
  8. Absolute requirement for oral iron therapy
  9. Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed)
  10. Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
  11. Inability to tolerate oral drug intake
  12. Any other medical condition that renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
  13. Inability to cooperate with study personnel or history of noncompliance
  14. Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554982

  Show 46 Study Locations
Sponsors and Collaborators
Keryx Biopharmaceuticals
Investigators
Study Chair: Julia B Lewis, MD Collaborative Study Group
  More Information

No publications provided

Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01554982     History of Changes
Other Study ID Numbers: KRX-0502-307
Study First Received: March 12, 2012
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Keryx Biopharmaceuticals:
Participation Limited
Long Term
Safety Extension

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency, Chronic
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 21, 2013