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Completed

NCT Number: NCT01554982

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

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes ESRD Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperphosphatemia Kidney Diseases Kidney Failure Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Failure Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

RCMI-Clinical Research Center, Rio Piedras, PR, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Willing and able to give informed consent

Exclusion criteria

  • Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in first period
  • Any subject in Study KRX-0502-304 SAP who early terminated from the trial
  • Any subject who participated in Study KRX-0502-304 but declined EAP
  • Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
  • History of malignancy in the last five years
  • Previous intolerance to KRX-0502 (ferric citrate)
  • Intolerance to oral iron-containing products
  • Absolute requirement for oral iron therapy
  • Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed)
  • Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
  • Inability to tolerate oral drug intake
  • 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
  • Inability to cooperate with study personnel or history of noncompliance
  • Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.

Treatment and study plan

Ferric citrate

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Keryx Biopharmaceuticals

Industry

Registry information

Official study title

A Long-Term Safety Extension Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 15, 2012
Registry last updated
Jul 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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