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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00560820
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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).

Condition or disease Intervention/treatment Phase
β-thalassemia Transfusional Iron Overload Drug: Deferasirox Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2007
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Thalassemia
Drug Information available for: Deferasirox

Arms and Interventions
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Arm Intervention/treatment
Experimental: Deferasirox
30 mg/kg/day
 Drug: Deferasirox
30 mg/kg/day
Other Name: ICL670


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

Secondary Outcome Measures :
  1. Effect of deferasirox on standard markers of renal function [ Time Frame: Once a month ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560820


Locations
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Italy
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
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00560820    
Other Study ID Numbers: CICL670A2123
2006-006838-17 ( EudraCT Number )
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: June 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
β-thalassemia
transfusional iron overload
renal function
renal biomarkers
deferasirox
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
 Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Deferasirox
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action