Transfusional Iron Overload Clinical Trial
Official title:
Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload
Verified date | June 2016 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 11 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - Male or female patients = 18 years of age without prior history of deferasirox treatment - ß-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. |
Country | Name | City | State |
---|---|---|---|
Italy | Novartis Investigative Site | Cagliari | CA |
Italy | Novartis Investigative Site | Genova | GE |
Italy | Novartis Investigative Site | Orbassano |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of deferasirox on renal hemodynamics in patients with ß-thalassemia and transfusional iron overload. | Once a month | ||
Secondary | Effect of deferasirox on standard markers of renal function | Once a month |
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