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

This study has been terminated.

First Received: August 25, 2005 Last Updated: September 6, 2006 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus Cyclosporine Cyclosporin

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	0468H1-318
Study First Received:	August 25, 2005
Last Updated:	September 6, 2006
ClinicalTrials.gov Identifier:	NCT00137345 History of Changes
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

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Antibiotics, Antineoplastic
Cyclosporins
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents

ClinicalTrials.gov processed this record on November 25, 2009