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

• ClinicalTrials.gov Identifier: NCT00560820
• Recruitment Status: Completed
• First Posted: November 20, 2007
• Last Update Posted: December 9, 2020
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: November 19, 2007
• First Posted Date: November 20, 2007
• Last Update Posted Date: December 9, 2020
• Study Start Date: September 2007
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 15, 2009): Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload. [ Time Frame: Once a month ]
• Original Primary Outcome Measures (submitted: November 19, 2007): Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload.
• Current Secondary Outcome Measures (submitted: December 11, 2009): Effect of deferasirox on standard markers of renal function [ Time Frame: Once a month ]
• Original Secondary Outcome Measures (submitted: November 19, 2007): Effect of deferasirox on standard markers of renal function
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• β-thalassemia
• Transfusional Iron Overload

Intervention

Drug: Deferasirox

30 mg/kg/day

Other Name: ICL670

Study Arms

Experimental: Deferasirox

30 mg/kg/day

Intervention: Drug: Deferasirox

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 20, 2016): 11
• Original Estimated Enrollment (submitted: November 19, 2007): 8
• Actual Study Completion Date: April 2012
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT00560820
• Other Study ID Numbers: CICL670A2123; 2006-006838-17 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: Not Provided
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Novartis
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals
• Study Director: Novartis Pharmaceuticals; Novartis Pharmeceuticals

• PRS Account: Novartis
• Verification Date: June 2016