Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to evaluate the effect of deferasirox on renal hemodynamics by determining glomerular filtration rate (GFR), renal plasma flow (RPF) and filtration fraction (FF).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Deferasirox

Criteria

Inclusion criteria:

• Male or female patients ≥ 18 years of age without prior history of deferasirox treatment

• β-thalassemia patients receiving regular transfusions every 2-5 weeks

• Transfusion history of ≥ 20 units of packed red blood cells

Exclusion criteria:

• Abnormal renal function at baseline

• ALT greater than 5 x ULN at screening

• Patients with underlying cardiac disease requiring continuous iron chelation therapy

Other protocol-defined inclusion/exclusion criteria may apply.