Clinical trial NCT00129961: Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Neoplasms
Kidney Transplantation
Keywords: Kidney
Transplant
Skin Cancer
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year
timeFrame: up to 24 months
Secondary outcomes:
measure: Time to First Biopsy Confirmed New NMSC Lesion.
timeFrame: up to 24 months
measure: Number of Lesion Free Subjects
timeFrame: up to 24 months
measure: Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC)
timeFrame: up to 24 months
measure: Grade Distribution of NMSC Lesions
timeFrame: up to 24 months
measure: Number of Recurrent NMSC Lesions Per Subject-year
timeFrame: up to 24 months
measure: Subjects Reporting Incidence of Metastatic Disease Related to NMSC.
timeFrame: up to 24 months
measure: Death Due to NMSC
timeFrame: up to 24 months
measure: Number of Subjects Who Discontinue Assigned Therapy
timeFrame: up to 24 months
measure: Nankivell-Calculated Glomerular Filtration Rate (GFR)
timeFrame: At 24 months (week 104)
measure: Serum Creatinine Level
timeFrame: At 24 months (Week 104)
measure: Number of Participants That Died
timeFrame: up to 24 months
measure: Graft Survival Measured by Graft Loss
timeFrame: up to 24 months
measure: Number of Subjects With Biopsy-Confirmed Acute Rejection
timeFrame: up to 24 months
measure: Spot Urine Protein:Creatinine Ratio
timeFrame: At 24 months (Week 104)
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Madison
country: United States
state: Wisconsin
city: Camperdown
country: Australia
state: New South Wales
city: Wooloongabba
country: Australia
state: Queensland
city: Woodville
country: Australia
state: South Australia
city: Adelaide
country: Australia
city: Clayton
country: Australia
city: Herston
country: Australia
city: Parkville
country: Australia
city: Randwick
country: Australia
city: Westmead
country: Australia
city: Vancouver
country: Canada
state: British Columbia
city: Grafton
country: New Zealand
state: Auckland
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Canada, clintrialparticipation@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Australia, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For New Zealand, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campbell SB, Walker R, Tai SS, Jiang Q, Russ GR. Randomized controlled trial of sirolimus for renal transplant recipients at high risk for nonmelanoma skin cancer. Am J Transplant. 2012 May;12(5):1146-56. doi: 10.1111/j.1600-6143.2012.04004.x. Epub 2012 Mar 15.