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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00560820
Collaborator
(none)
11
Enrollment
3
Locations
1
Arm
55
Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Sep 1, 2007
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Deferasirox

30 mg/kg/day

Drug: Deferasirox
30 mg/kg/day
Other Names:
  • ICL670

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload. [Once a month]

    Secondary Outcome Measures

    1. Effect of deferasirox on standard markers of renal function [Once a month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Cagliari CA Italy 09121
    2 Novartis Investigative Site Genova GE Italy 16128
    3 Novartis Investigative Site Orbassano Italy 10043

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
    • Study Director: Novartis Pharmaceuticals, Novartis Pharmeceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00560820
    Other Study ID Numbers:
    • CICL670A2123
    • 2006-006838-17
    First Posted:
    Nov 20, 2007
    Last Update Posted:
    Dec 9, 2020
    Last Verified:
    Jun 1, 2016
    Keywords provided by Novartis Pharmaceuticals
    β-thalassemia
    transfusional iron overload
    renal function
    renal biomarkers
    deferasirox
    Additional relevant MeSH terms:
    Thalassemia
    beta-Thalassemia
    Iron Overload
    Deferasirox

    Study Results

    No Results Posted as of Dec 9, 2020