Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload
2 other identifiers
interventional
11
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2007
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 19, 2007
CompletedFirst Posted
Study publicly available on registry
November 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedDecember 9, 2020
June 1, 2016
4.6 years
November 19, 2007
December 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload.
Once a month
Secondary Outcomes (1)
Effect of deferasirox on standard markers of renal function
Once a month
Study Arms (1)
Deferasirox
EXPERIMENTAL30 mg/kg/day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Abnormal renal function at baseline
- ALT greater than 5 x ULN at screening
- Patients with underlying cardiac disease requiring continuous iron chelation therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Novartis Investigative Site
Cagliari, CA, 09121, Italy
Novartis Investigative Site
Genova, GE, 16128, Italy
Novartis Investigative Site
Orbassano, 10043, Italy
Related Publications (1)
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.
PMID: 25402221DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmeceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2007
First Posted
November 20, 2007
Study Start
September 1, 2007
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
December 9, 2020
Record last verified: 2016-06