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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01554982
First Posted: March 15, 2012
Last Update Posted: July 13, 2016
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.
Information provided by (Responsible Party):
Keryx Biopharmaceuticals
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Keryx Biopharmaceuticals:

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


Other Outcome Measures:
  • Serum Phosphorus- Baseline [ Time Frame: Baseline ]
  • Serum Phosphorus- Week 48 [ Time Frame: 48 weeks ]
  • Ferritin- Baseline [ Time Frame: Baseline ]
  • Ferritin- Week 48 [ Time Frame: 48 weeks ]
  • Transferrin Saturation (TSAT) - Baseline [ Time Frame: Baseline ]
  • TSAT- Week 48 [ Time Frame: 48 weeks ]
  • Hemoglobin- Baseline [ Time Frame: Baseline ]
  • Hemoglobin- Week 48 [ Time Frame: 48 weeks ]
  • IV Iron Use [ Time Frame: 48 weeks ]
    Percent of subjects with No IV iron intake from first dose of study drug to Week 48


Enrollment: 168
Study Start Date: August 2012
Study Completion Date: August 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ferric Citrate
Open label extension of those completing study KRX-0304
Drug: ferric citrate
Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Other Names:
  • Auryxia
  • KRX-0502

Detailed Description:
This study was an open-label, 48-week safety extension of Study KRX-0502-304 (Study 304), to evaluate the safety of long-term use of KRX-0502 in subjects with ESRD for up to 2 years of cumulative exposure. Subjects who completed the Safety Assessment Period (SAP) and, if eligible, the Efficacy Assessment Period (EAP) of Study 304, independent of their assigned treatment arm in the SAP or EAP of Study 304, were eligible for participation in this long-term safety extension study. No new subjects were permitted to enter this study.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Males or non-pregnant, non-breast-feeding females who participated in the Safety Assessment Period (SAP), and if eligible, the Efficacy Assessment Period (EAP) 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 SAP who early terminated from the trial
  3. Any subject who participated in Study KRX-0502-304 but declined EAP
  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 rendered 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
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): NCT01554982


  Show 34 Study Locations
Sponsors and Collaborators
Keryx Biopharmaceuticals
Investigators
Study Chair: Julia B Lewis, MD Collaborative Study Group
  More Information

Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01554982     History of Changes
Other Study ID Numbers: KRX-0502-307
First Submitted: March 12, 2012
First Posted: March 15, 2012
Results First Submitted: September 24, 2015
Results First Posted: July 13, 2016
Last Update Posted: July 13, 2016
Last Verified: June 2016

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
Ferric Compounds
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hematinics