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

Primary Purpose

β-thalassemia, Transfusional Iron Overload

Status

Completed

Phase

Phase 1

Locations

Italy

Study Type

Interventional

Intervention

Deferasirox

About this trial

This is an interventional treatment trial for β-thalassemia focused on measuring β-thalassemia, transfusional iron overload, renal function, renal biomarkers, deferasirox

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deferasirox

Arm Description

30 mg/kg/day

Outcomes

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

Full Information

NCT ID

NCT00560820

First Posted

November 19, 2007

Last Updated

December 6, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00560820

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

β-thalassemia, Transfusional Iron Overload

Keywords

β-thalassemia, transfusional iron overload, renal function, renal biomarkers, deferasirox

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Deferasirox

Arm Type

Experimental

Arm Description

30 mg/kg/day

Intervention Type

Drug

Intervention Name(s)

Deferasirox

Other Intervention Name(s)

ICL670

Intervention Description

30 mg/kg/day

Primary Outcome Measure Information:

Title

Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload.

Time Frame

Once a month

Secondary Outcome Measure Information:

Title

Effect of deferasirox on standard markers of renal function

Time Frame

Once a month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmeceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Cagliari

State/Province

ZIP/Postal Code

09121

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16128

Country

Italy

Facility Name

Novartis Investigative Site

City

Orbassano

ZIP/Postal Code

10043

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

25402221

Citation

Piga A, Fracchia S, Lai ME, Cappellini MD, Hirschberg R, Habr D, Wegener A, Bouillaud E, Forni GL. Deferasirox effect on renal haemodynamic parameters in patients with transfusion-dependent beta thalassaemia. Br J Haematol. 2015 Mar;168(6):882-90. doi: 10.1111/bjh.13217. Epub 2014 Nov 17.

Results Reference

derived

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7823

Description

Results for CICL670A2123 can be found on the Novartis Clinical Trials Results Website

Learn more about this trial

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

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