Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00967993|
Recruitment Status : Completed
First Posted : August 28, 2009
Results First Posted : November 18, 2014
Last Update Posted : December 5, 2014
|Condition or disease||Intervention/treatment|
|Hyperphosphatemia End-stage Renal Disease Renal Failure Chronic Requiring Hemodialysis||Drug: ferric citrate|
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|Official Title:||A 6-Week Feasibility Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
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
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|