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

Phase 1

Completed

• Conditions: β-thalassemia; Transfusional Iron Overload
• Interventions: Drug: Deferasirox

• Registration Number: NCT00560820
• Lead Sponsor: Novartis Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2016-06
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deferasirox	Deferasirox	30 mg/kg/day

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effect of deferasirox on standard markers of renal function	Once a month

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇹 Orbassano, Italy