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OpenTrials
Completed

NCT Number: NCT00560820

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).

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Key information

Conditions

β-thalassemia Transfusional Iron Overload

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Cagliari, CA, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deferasirox

Drug

30 mg/kg/day

Other names: ICL670

Primary outcomes

  1. Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload.

    Time frame: Once a month

Secondary outcomes

  1. Effect of deferasirox on standard markers of renal function

    Time frame: Once a month

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Nov 20, 2007
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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