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Ferric Citrate in Patients With End-Stage Renal Disease on Dialysis

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: ESRD; Dialysis; Hyperphosphatemia

Intervention: Calcium acetate, sevelamer carbonate (Drug); Ferric citrate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Pennsylvania

Summary

The main purpose of this study is to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with end-stage renal disease undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period. Main eligibility 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 Visit (Visit 0), Serum phosphorus levels greater than or equal to 2. 5 mg/dL and less than or equal to 8. 0 mg/dL at Screening Visit (Visit 0), Serum phosphorus greater than or equal to 6. 0 mg/dL during the Washout Period (Visits 2 or 3), taking 3 to 18 pills/day of calcium acetate, calcium carbonate, lanthanum carbonate, and/or sevelamer (carbonate or hydrochloride or equivalent sevelamer powder) or any other agent serving as a phosphate binder, or any combination and serum ferritin less than 1000 micrograms/L and less than TSAT 50% at the Screening Visit (Visit 0).

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary efficacy outcome of this trial will be the effect of ferric citrate vs. placebo on the change in serum phosphorus from study-baseline (Visit 21, Week 52) to end of the Efficacy Assessment Period (Visit 25, Week 56).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Males or non-pregnant, non-breast-feeding females 2. Age greater than or equal to 18 years 3. On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening Visit (Visit 0) 4. Serum phosphorus levels greater than or equal to 2. 5 mg/dL and less than or equal to 8. 0 mg/dL at Screening Visit (Visit 0) 5. Serum phosphorus greater than or equal to 6. 0 mg/dL during the Washout Period (visits 2 or 3) 6. Taking 3 to 18 pills per day (or 2-10 gm) of calcium acetate, calcium carbonate, lanthanum carbonate, and/or sevelamer (carbonate or hydrochloride or equivalent sevelamer powder) or any other agent serving as a phosphate binder, or any combination of these agents as reported by the patient at Screening Visit (Visit 0) 7. Serum ferritin less than 1000 micrograms/L and TSAT less than 50% at the Screening Visit (Visit 0) 8. Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate 9. Willing and able to give informed consent

10. Life expectancy greater than 1 year -

Exclusion Criteria: 1. Parathyroidectomy within six months prior to Screening Visit (Visit 0) 2. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease 3. Serum phosphorus levels greater than or equal to 10. 0 mg/dL documented in the three monthly laboratories (done routinely in the dialysis unit) in all of the 3 months prior to the Screening Visit (Visit 0) 4. Patients with baseline ferritin levels of greater than or equal to 1000 ng/mL and TSAT greater than or equal to 50% documented in the three monthly labs prior to the screening visit 5. History of multiple drug allergies or intolerances 6. History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC) 7. Previous intolerance to oral ferric citrate 8. Intolerance to oral iron-containing products 9. Absolute requirement for oral iron therapy 10. Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed) 11. Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals 12 Psychiatric disorder that interferes with the patients ability to comply with the study protocol 13. Inability to tolerate oral drug intake 14. Intolerance to calcium acetate and sevelamer carbonate 15. Planned surgery or hospitalization during the trial (for example scheduled outpatient access surgery, eye laser surgery, etc allowed-Please contact CCC with any question) 16. 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 17. Receipt of any investigational drug within 30 days of Screening Visit (Visit 0) 18. Inability to cooperate with study personnel or history of noncompliance 19. Unsuitable for this trial per Investigators

clinical judgment. -

Locations and Contacts

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Additional Information

Starting date: April 2011
Last updated: March 14, 2013

Page last updated: August 23, 2015

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