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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: November 19, 2007
Last updated: April 20, 2016
Last verified: April 2016
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).

Condition Intervention Phase
Transfusional Iron Overload
Drug: Deferasirox
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload. [ Time Frame: Once a month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect of deferasirox on standard markers of renal function [ Time Frame: Once a month ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: September 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deferasirox
30 mg/kg/day
Drug: Deferasirox
30 mg/kg/day
Other Name: ICL670


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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

Other protocol-defined inclusion/exclusion criteria may apply.

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Please refer to this study by its identifier: NCT00560820

Novartis Investigative Site
Cagliari, CA, Italy, 09121
Novartis Investigative Site
Genova, GE, Italy, 16128
Novartis Investigative Site
Orbassano, Italy, 10043
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00560820     History of Changes
Other Study ID Numbers: CICL670A2123  2006-006838-17 
Study First Received: November 19, 2007
Last Updated: April 20, 2016
Health Authority: United States: Food and Drug Administration
Italy: The Italian Medicines Agency

Keywords provided by Novartis:
transfusional iron overload
renal function
renal biomarkers

Additional relevant MeSH terms:
Iron Overload
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Chelating Agents
Iron Chelating Agents
Molecular Mechanisms of Pharmacological Action
Sequestering Agents processed this record on May 30, 2016