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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00560820

Enrollment

Registered

2007-11-20

Start date

2007-09-30

Completion date

2012-04-30

Last updated

2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transfusional Iron Overload, β-thalassemia

Keywords

β-thalassemia, transfusional iron overload, renal function, renal biomarkers, deferasirox

Brief 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).

Interventions

DRUGDeferasirox

30 mg/kg/day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload.	Once a month

Secondary

Measure	Time frame
Effect of deferasirox on standard markers of renal function	Once a month

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026