Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00129961
• Date of registration: 01/08/2005
• Prospective Registration: Yes
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
• Scientific 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
• Date of first enrolment: August 2005
• Target sample size: 86
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00129961
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Australia, Canada, New Zealand, United States

Contacts

• Name: Trial Manager
• Affiliation: For New Zealand, [e-mail]

• Name: Trial Manager
• Affiliation: For Canada, [e-mail]

• Name: Trial Manager
• Affiliation: For Australia, [e-mail]

• Name: Medical Monitor
• Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Kidney transplant at least 1 year prior

- Subjects with a functioning renal allograft with calculated glomerular filtration rate
(GFR) =40mL/min (Nankivell method) and proteinuria =500mg/day.

- Stable on cyclosporine or tacrolimus-based multi-drug immunosuppressive regimen

- History of NMSC within last 3 years

Exclusion Criteria:

- History of other cancer within last 3 years

- NMSC with metastatic disease or more than 20 NMSC lesions in last 12 months

- Multiple organ transplant



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Skin Neoplasms

Kidney Transplantation

Intervention(s)

Drug: sirolimus

Drug: cyclosporine or tacrolimus

Primary Outcome(s)

New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year [Time Frame: up to 24 months]

Secondary Outcome(s)

Time to First Biopsy Confirmed New NMSC Lesion. [Time Frame: up to 24 months]

Death Due to NMSC [Time Frame: up to 24 months]

Grade Distribution of NMSC Lesions [Time Frame: up to 24 months]

Number of Lesion Free Subjects [Time Frame: up to 24 months]

Number of Subjects Who Discontinue Assigned Therapy [Time Frame: up to 24 months]

Nankivell-Calculated Glomerular Filtration Rate (GFR) [Time Frame: At 24 months (week 104)]

Number of Participants That Died [Time Frame: up to 24 months]

Graft Survival Measured by Graft Loss [Time Frame: up to 24 months]

Subjects Reporting Incidence of Metastatic Disease Related to NMSC. [Time Frame: up to 24 months]

Spot Urine Protein:Creatinine Ratio [Time Frame: At 24 months (Week 104)]

Number of Subjects With Biopsy-Confirmed Acute Rejection [Time Frame: up to 24 months]

Number of Recurrent NMSC Lesions Per Subject-year [Time Frame: up to 24 months]

Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) [Time Frame: up to 24 months]

Serum Creatinine Level [Time Frame: At 24 months (Week 104)]

Secondary ID(s)

0468H1-407

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/03/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00129961