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COMPLETEDPhase 1NCT00560820

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

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).

Lead sponsor: Novartis Pharmaceuticals•3 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Novartis Pharmaceuticals

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 9, 2020Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment11

Start dateSep 2007

Last updatedDec 9, 2020

Condition

β-thalassemia Transfusional Iron Overload

Locations shown

Novartis Investigative Site

Cagliari, CA

Novartis Investigative Site

Genova, GE

Novartis Investigative Site

Orbassano

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2020Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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