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.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00560820
First received: November 19, 2007
Last updated: January 22, 2013
Last verified: January 2013
  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 1

Study Type: Interventional
Study Design: 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: 12
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00560820     History of Changes
Other Study ID Numbers: CICL670A2123, 2006-006838-17
Study First Received: November 19, 2007
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration
Italy: The Italian Medicines Agency

Keywords provided by Novartis:
β-thalassemia
transfusional iron overload
renal function
renal biomarkers
deferasirox

Additional relevant MeSH terms:
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014