Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
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 renal disease (ESRD).
End-stage Renal Disease
Renal Failure Chronic Requiring Hemodialysis
Drug: ferric citrate
|Study Design:||Time Perspective: Retrospective|
|Official Title:||A 6-Week Feasibility Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)|
- The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- The Incidence of Treatment-emergent Adverse Events (New or Worsened From Study Drug Initiation) Will be Summarized by Body System, Severity, Type of Adverse Event, and Presumed Relationship to the Study Drug. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
KRX-0502 (ferric citrate)
KRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate. All patients initiated on study drug will start with a fixed dose of KRX-0502 (ferric citrate) of 6 caplets per day.
Patients will be titrated at Visits 4, 5, and 6 based on serum phosphorus lab results. If serum phosphorus levels go below normal, there will be a decrease in pills; if serum phosphorus levels go above normal, there wil be an increase in pills. The maximum number of KRX-0502 (ferric citrate) caplets per day will be 12, or 12 g/day of ferric citrate.
Patients will take study drug orally with meals or snacks or within one hour after their meals or snacks.
Drug: ferric citrate
KRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate
Other Name: KRX-0502
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 approximately twelve non-diabetic patients) in Israel will be initiated on KRX-0502 (ferric citrate). The study will consist of a two-week washout period immediately followed by a six-week treatment period in. Patients will be initiated on study drug over two to three weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967993
|Barzilai Medical Center Ben-Gurion University|
|Ashkelon, Israel, 78306|
|Hadassah University Hospital-Ein Kerem|
|Jerusalem, Israel, 91120|
|Assaf Haraofeh Medical Center|
|Zerifin, Israel, 70300|
|Principal Investigator:||Itamar Raz, MD||Hadassah University Hospital-Ein Kerem|