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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00560820
Other study ID # CICL670A2123
Secondary ID 2006-006838-17
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2007
Est. completion date April 2012

Study information

Verified date June 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Deferasirox
30 mg/kg/day

Locations

Country Name City State
Italy Novartis Investigative Site Cagliari CA
Italy Novartis Investigative Site Genova GE
Italy Novartis Investigative Site Orbassano

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT00390858 - A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload. Phase 2
Completed NCT01039636 - Safety and Pharmacokinetic Study of Escalating Multiple Doses of an Iron Chelator in Patients With Iron Overload Phase 1
Completed NCT00600938 - Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload Phase 2
Completed NCT00673608 - Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload Phase 4
Withdrawn NCT01927913 - Treatment of Iron Overload Requiring Chelation Therapy Phase 2
Completed NCT01241357 - High-Tc Susceptometer to Monitor Transfusional Iron Overload Phase 2
Completed NCT01838291 - Active Drug Surveillance Program of Ferriprox Use N/A
Completed NCT01044186 - A Protocol to Allow Treatment With ICL670 for Patients With or at Risk of Life-threatening Complications of Transfusional Iron Overload Who Are Unable to Tolerate Other Iron Chelators Because of Documented Severe Toxicity Phase 2
Completed NCT00379483 - Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload Phase 2
Terminated NCT01326845 - Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study Phase 4
Completed NCT01186419 - Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload Phase 2
Terminated NCT01363908 - Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload Phase 2