Phase I Study to Examine the Effect of Deferasirox on Renal NCT00560820

Updated 06/21/2024

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

Related Conditions & MeSH terms

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

External Links

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