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

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ClinicalTrials.gov Identifier: NCT01554982
Recruitment Status : Completed
First Posted : March 15, 2012
Results First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
End Stage Renal Disease Kidney Failure Renal Failure Hyperphosphatemia ESRD Drug: ferric citrate Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
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
Study Start Date : August 2012
Primary Completion Date : June 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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:
  1. Serum Phosphorus- Baseline [ Time Frame: Baseline ]
  2. Serum Phosphorus- Week 48 [ Time Frame: 48 weeks ]
  3. Ferritin- Baseline [ Time Frame: Baseline ]
  4. Ferritin- Week 48 [ Time Frame: 48 weeks ]
  5. Transferrin Saturation (TSAT) - Baseline [ Time Frame: Baseline ]
  6. TSAT- Week 48 [ Time Frame: 48 weeks ]
  7. Hemoglobin- Baseline [ Time Frame: Baseline ]
  8. Hemoglobin- Week 48 [ Time Frame: 48 weeks ]
  9. IV Iron Use [ Time Frame: 48 weeks ]
    Percent of subjects with No IV iron intake from first dose of study drug to Week 48

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

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.

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

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Sponsors and Collaborators
Keryx Biopharmaceuticals
Study Chair: Julia B Lewis, MD Collaborative Study Group

Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01554982     History of Changes
Other Study ID Numbers: KRX-0502-307
First Posted: March 15, 2012    Key Record Dates
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
Urologic Diseases
Renal Insufficiency, Chronic
Phosphorus Metabolism Disorders
Metabolic Diseases
Citric Acid
Ferric Compounds
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action