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NCT Number: NCT01191255

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

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.

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Key information

Conditions

Hyperphosphatemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications 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 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

Department of Nephrology and Hypertension Brazilai Medical Center, Ashkelon, Israel

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About this study

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.

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
  • Age ≥18 years
  • On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening
  • Serum phosphorus ≥6.0 mg/dL for study entry
  • Taking less than 3-18 pills/day of current phosphate binder
  • Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate
  • Willing and able to give informed consent
  • Life expectancy >1 year

Exclusion criteria

  • Parathyroidectomy within six months prior to Screening
  • Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
  • History of multiple drug allergies or intolerances
  • History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
  • Previous intolerance to oral ferric citrate
  • Intolerance to oral iron-containing products
  • Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
  • Inability to tolerate oral drug intake
  • Intolerance to calcium acetate and sevelamer carbonate
  • 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
  • Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
  • Inability to cooperate with study personnel or history of noncompliance
  • Unsuitable for this trial per Investigator's clinical judgment.

Treatment and study plan

ferric citrate, ca acetate, sevelamer carbonate, placebo

Drug

All intervention doses will be based on serum phosphorus levels and/or drug label requirements

Other names: PhosLo, Renvela, KRX-0502, Zerenex

Primary outcomes

  1. Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)

    Time frame: 4 weeks

    Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.

Secondary outcomes

  1. Change in Mean Serum Ferritin From Baseline to Week 52

    Time frame: 52 weeks

  2. Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52)

    Time frame: 52 weeks

  3. IV Iron Analysis

    Time frame: 52 weeks

    Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52)

  4. ESA Analysis

    Time frame: 52 weeks

    Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52)

Sponsors and collaborators

Lead sponsor

Keryx Biopharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2010
Registry last updated
Dec 10, 2014

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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