Status:
COMPLETED
Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
Lead Sponsor:
Keryx Biopharmaceuticals
Conditions:
Hyperphosphatemia
End-stage Renal Disease
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a dietary phosphate binder in controlling and managing serum phosphorus levels in patients with end-stage re...
Detailed Description
This is a multi-center, non-blinded, efficacy and tolerability trial in patients with ESRD on dialysis three times per week. Approximately 24 patients (approximately twelve diabetic patients and appro...
Eligibility Criteria
Inclusion
- Males and non-pregnant, non-lactating females
- Age \> 18 years
- On thrice weekly hemodialysis for at least the previous three months prior to screening
- Serum phosphorus levels ≥ 2.5 mg/dL and \< 8.5 mg/dL at Screening Visit (Visit 0)
- Serum phosphorus levels \> 5.5 mg/dL at Study Drug Initiation Visit (Visit 3)
- Taking 3 to 18 tablets/capsules/day of calcium acetate calcium carbonate, lanthanum carbonate, sevelamer (hydrochloride or carbonate), or any combination of these agents as reported by the patient at screening
- Serum ferritin \<1000micrograms/L and Transferrin Saturation (TSAT) \<50%
- Willing to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate)
- Willing and able to give informed consent
Exclusion
- Parathyroidectomy within six months prior to Screening Visit (Visit 0)
- Actively symptomatic gastrointestinal bleeding and inflammatory bowel disease
- Serum phosphorus levels \>10.0 mg/dL documented in the three monthly laboratories (done routinely in the dialysis unit) in the three months prior to the Screening Visit (Visit 0)
- History of multiple drug allergies
- History of malignancy in the last five years (treated cervical or skin cancer may be permitted if approved by Keryx)
- Previous intolerance to oral ferric citrate
- Absolute requirement for oral iron therapy
- Absolute requirement for Vitamin C (multivitamins \[Centrum, Nephrocaps, Renaphro, etc.\] allowed)
- Absolute requirement for calcium, magnesium, or aluminum containing drugs with meals
- Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
- Inability to tolerate oral drug intake
- Planned surgery or hospitalization during the study (scheduled outpatient access surgery allowed)
- Any other medical condition that renders the patient unable to or unlikely to complete the study or that would interfere with optimal participation in the study or produce significant risk to the patient
- Receipt of any investigational drug within 30 days of randomization
- Inability to cooperate with study personnel or history of noncompliance
- Prior exposure to ferric citrate
- Patients with hemochromatosis or Thalassemia
Key Trial Info
Start Date :
January 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00967993
Start Date
January 1 2010
End Date
May 1 2010
Last Update
December 5 2014
Active Locations (3)
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1
Barzilai Medical Center Ben-Gurion University
Ashkelon, Israel, 78306
2
Hadassah University Hospital-Ein Kerem
Jerusalem, Israel, 91120
3
Assaf Haraofeh Medical Center
Ẕerifin, Israel, 70300