Study Evaluating Sirolimus in Non-Melanoma Skin Cancer in Kidney Transplant Recipients

This study has been completed.

First Received on August 1, 2005. Last Updated on February 2, 2009 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00129961

Purpose

The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.

Condition	Intervention	Phase
Graft vs Host Disease Kidney Transplantation Skin Neoplasms	Drug: sirolimus Drug: cyclosporine or tacrolimus	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Randomized, Open-Label Study to Compare the Rate of New Non-Melanoma Skin Cancer in Maintenance Renal Allograft Recipients Converted to a Sirolimus-Based Regimen Versus Continuation of a Calcineurin Inhibitor-Based Regimen

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Transplantation Skin Cancer

Drug Information available for: Sirolimus Cyclosporine Cyclosporin Tacrolimus anhydrous Tacrolimus Everolimus CCI 779

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

Number of new NMSC lesions per patient per year over 24 months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Malignancy, kidney function, patient and graft survival at 6, 12 and 24 months [ Time Frame: 6,12,24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	August 2005
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Conversion to a sirolimus based regimen	Drug: sirolimus
Active Comparator: 2 Continuation of the CNI regimen	Drug: cyclosporine or tacrolimus

Eligibility

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

Criteria

Inclusion Criteria:

Kidney transplant at least 1 year prior with functioning allograft
Stable on cyclosporine or tacrolimus multi-drug therapy regimen
History of NMSC within last 3 years

Exclusion Criteria:

History of other cancer within last 5 years
More than 20 NMSC lesions in last 12 months
Multiple organ transplant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129961

Show 23 Study Locations

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:	Trial Manager	For Canada, clintrialparticipation@wyeth.com
Principal Investigator:	Trial Manager	For Australia, medinfo@wyeth.com
Principal Investigator:	Trial Manager	For New Zealand, medinfo@wyeth.com

More Information

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00129961 History of Changes
Other Study ID Numbers:	0468H1-407
Study First Received:	August 1, 2005
Last Updated:	February 2, 2009
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Kidney
Transplant
Skin Cancer

Additional relevant MeSH terms:

Neoplasms
Skin Neoplasms
Graft vs Host Disease
Carcinoma, Basal Cell
Carcinoma, Basosquamous
Carcinoma, Squamous Cell
Neoplasms by Site
Skin Diseases
Immune System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Cyclosporins

Cyclosporine
Sirolimus
Everolimus
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012