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

Novartis

Status and phase: Completed; Phase 1

Conditions: Transfusional Iron Overload; β-thalassemia

Treatments: Drug: Deferasirox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00560820

2006-006838-17 (EudraCT Number)

CICL670A2123

Details and patient eligibility

About

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).

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Deferasirox

Experimental group

Description:

30 mg/kg/day

Treatment:

Drug: Deferasirox