NCT00967993

Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

A 6-Week Feasibility Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Keryx Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 renal disease (ESRD).

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 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.

Conditions

• Hyperphosphatemia
• End-stage Renal Disease
• Renal Failure Chronic Requiring Hemodialysis

Interventions

Type	Name	Description
DRUG	ferric citrate	KRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-08-28
• Last updated: 2014-12-05
• Results posted: 2014-11-18

Locations

3 sites across 1 country: Israel