CompletedPhase 3

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

United States441 participantsStarted 2010-10

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 4 weeks

Trial details

NCT IDNCT01191255

SponsorKeryx Biopharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-01

Results submitted2014-10-04

View on ClinicalTrials.gov More Hyperphosphatemia trials