Study of the Safety and Efficacy of Conversion From a CNI to Sirolimus in Renally-Impaired Heart Transplant Recipients - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00369382

Purpose

The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.

Condition	Intervention	Phase
Graft Rejection Kidney Failure	Drug: cyclosporine or tacrolimus Drug: sirolimus	Phase IV

MedlinePlus related topics: Heart Transplantation Kidney Failure

Drug Information available for: Tacrolimus Cyclosporin Cyclosporine Sirolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Open-Label Study to Compare the Safety and Efficacy of Conversion From a Calcineurin Inhibitor to Sirolimus Vs Continued Use of a Calcineurin Inhibitor in Heart Transplant Recipients With Mild-Moderate Impaired Renal Function

Further study details as provided by Wyeth:

Primary Outcome Measures:

Calculated change from baseline of creatinine clearance (using the Cockcroft-Gault equation) at 52 weeks. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum creatinine; acute rejections; antibody use for acute rejection; patients requiring conversion back to CNI therapy. [ Time Frame: 4, 16, 24, 32 & 40 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	September 2006
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Continuation of CNI regimen	Drug: cyclosporine or tacrolimus
2: Experimental Group 2 (CNI-Free) Conversion to SRL-based regimen	Drug: sirolimus

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cardiac transplant recipients age 18 years or older receiving cyclosporine or tacrolimus since the time of transplant.
12 months after cardiac transplantation but less than 60 months post-transplantation.

Exclusion Criteria:

Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after kidney transplant recipients).
Prior or current use of sirolimus or everolimus.
History of acute rejection within the last 3 months, malignancy within the last 5 years (except for adequately treated basal cell or squamous cell carcinoma of the skin), and HIV patients.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369382

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Show 22 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Canada, clintrialparticipation@wyeth.com
Principal Investigator:	Trial Manager	For Spain, infomed@wyeth.com
Principal Investigator:	Trial Manager	For Austria, WPVIMED@wyeth.com
Principal Investigator:	Trial Manager	For Switzerland, med@wyeth.com
Principal Investigator:	Trial Manager	For Australia and New Zealand, medinfo@wyeth.com

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0468E7-408
Study First Received:	August 25, 2006
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00369382
Health Authority:	Australia: Human Research Ethics Committee; Austria: Federal Ministry for Health and Women; Canada: Health Canada; New Zealand: Health Research Council; Spain: Ministry of Health; Switzerland: Swissmedic; United States: Food and Drug Administration

Keywords provided by Wyeth:

Heart Transplant
Kidney Failure

Study placed in the following topic categories:

Sirolimus
Renal Insufficiency
Cyclosporine
Urologic Diseases
Clotrimazole
Miconazole

Tioconazole
Tacrolimus
Kidney Diseases
Cyclosporins
Kidney Failure

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