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Organ Transplant |
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Clinical Trial: Study Evaluating Sirolimus in the Prevention of New Non-Melanoma Skin Cancer in Kidney Transplant Recipients
This study is not yet open for patient recruitment.
Verified by Wyeth August 2005
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Purpose
The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer in renal transplant recipients.
| Condition | Intervention | Phase |
|---|---|---|
| NMSC in maintenance renal transplant recipients | Drug: Sirolimus | Phase IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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.
Further Study Details:
Primary Outcomes: No. of new NMSC lesions per pt. per yr. over 24 mos.
Secondary Outcomes: malignancy, renal function, pt. and graft survival at 6, 12 & 24 mos
Expected Total Enrollment: 200
Secondary Outcomes: malignancy, renal function, pt. and graft survival at 6, 12 & 24 mos
Expected Total Enrollment: 200
Study start: August 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Renal transplant at least 1 yr 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 malignancy within last 5 yrs
- > 20 NMSC lesions in last 12 mos
- Multiple organ transplant.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00129961
Australia
Wyeth Investigational Site, Woodville South, 5011, Australia
Study Coordinator clinicaltrialinfo@wyeth.com
Wyeth Investigational Site, Camperdown, 2050, Australia
Study Coordinator clinicaltrialinfo@wyeth.com
Wyeth Investigational Site, Woolloongabba, 4102, Australia
Study Coordinator clinicaltrialinfo@wyeth.com
Wyeth Investigational Site, Parkville, 3050, Australia
Study Coordinator clinicaltrialinfo@wyeth.com
Wyeth Investigational Site, Westmead, 2145, Australia
Study Coordinator clinicaltrialinfo@wyeth.com
Wyeth Investigational Site, Clayton, 3168, Australia
Study Coordinator clinicaltrialinfo@wyeth.com
Wyeth Investigational Site, Randwick, 2031, Australia
Study Coordinator clinicaltrialinfo@wyeth.com
Study chairs or principal investigators
Medical Monitor, MD, Study Director, Wyeth
More Information
Study ID Numbers: 0468H1-407
Last Updated: August 11, 2005
Record first received: August 1, 2005
ClinicalTrials.gov Identifier: NCT00129961
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 11, 2005
Record first received: August 1, 2005
ClinicalTrials.gov Identifier: NCT00129961
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- A Transplant Center//'s Dedicated Duo (Cleveland Clinic)
- Organ Donation and Transplantation (Cleveland Clinic)
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