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

This study is currently recruiting participants.

Verified by Novartis, May 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00560820

Purpose

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
β-Thalassemia Transfusional Iron Overload	Drug: Deferasirox	Phase I

Genetics Home Reference related topics: beta thalassemia

MedlinePlus related topics: Thalassemia

Drug Information available for: Deferasirox

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-Thalassemia Patients With Transfusional Iron Overload

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.

Secondary Outcome Measures:

Effect of deferasirox on standard markers of renal function

Estimated Enrollment:	8
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2011

Eligibility

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560820

Contacts

Contact: Novartis

41 61 324 1111

Locations

Italy
	Recruiting
Milano, Italy
	Recruiting
Genova, Italy
	Recruiting
Orbassano, Italy
	Recruiting
Cagliari, Italy

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CICL670A2123
Study First Received:	November 19, 2007
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00560820
Health Authority:	Italy: Italian Agency of Medicine

Keywords provided by Novartis:

β-thalassemia
transfusional iron overload
renal function
renal biomarkers
deferasirox

Study placed in the following topic categories:

Metabolic Diseases
Deferasirox
Hematologic Diseases
Anemia
Anemia, Hemolytic
Iron Metabolism Disorders
Thalassemia

Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hemoglobinopathies
Iron Overload
Hemoglobinopathy
Metabolic disorder
Iron

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009