Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00137345

Purpose

The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.

Condition	Intervention	Phase
Kidney Transplant	Drug: sirolimus	Phase III

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Corticosteroids Sirolimus Basiliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients

Further study details as provided by Wyeth:

Primary Outcome Measures:

To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)
Non-inferiority of the composite of graft loss and death at 52 weeks

Secondary Outcome Measures:

Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks
quality of life at 24, 52 and 104 weeks

Estimated Enrollment:	500
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Dialysis patients who will be receiving their first kidney transplant
Weight over 88 pounds (lbs.)

Exclusion Criteria:

Very high cholesterol levels
Obesity
Organ donor over 65 years of age if living; over 60 years of age if cadaveric.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137345

Show 82 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Germany, MedInfoDEU@wyeth.com
Principal Investigator:	Trial Manager	For Norway, Sweden, MedInfoNord@wyeth.com
Principal Investigator:	Trial Manager	For Australia, Taiwan, medinfo@wyeth.com
Principal Investigator:	Trial Manager	For Austria, WPVIMED@wyeth.com
Principal Investigator:	Trial Manager	For Italy, Greece, decresg@wyeth.com
Principal Investigator:	Trial manager	For Hungary, WPBUMED@wyeth.com
Principal Investigator:	Trial Manager	For Turkey, Erisc@wyeth.com
Principal Investigator:	Trial Manager	For South Africa, ZAFinfo@wyeth.com
Principal Investigator:	Trial Manager	For Argentina, Chile, scheima@wyeth.com, rendop@wyeth.com
Principal Investigator:	Trial Manager	For UK, ukmedonfo@wyeth.com
Principal Investigator:	Trial Manager	For Switzerland, med@wyeth.com

More Information

Study ID Numbers:	0468H1-318
Study First Received:	August 25, 2005
Last Updated:	September 6, 2006
ClinicalTrials.gov Identifier:	NCT00137345
Health Authority:	European Union: European Medicines Agency; United States: Food and Drug Administration

Keywords provided by Wyeth:

Randomized controlled trial
Clinical Trial Phase III
Drug therapy
Immunosuppression

Treatment outcome
Kidney transplantation
Kidney function tests

Study placed in the following topic categories:

Sirolimus
Basiliximab
Cyclosporine
Clotrimazole

Miconazole
Tioconazole
Mycophenolate mofetil
Cyclosporins

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antifungal Agents

Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009