Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
- Conditions
- Skin NeoplasmsKidney Transplantation
- Interventions
- Registration Number
- NCT00129961
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 cyclosporine or tacrolimus Continuation of a CNI-based regimen 1 sirolimus Conversion to a sirolimus-based regimen
- Primary Outcome Measures
Name Time Method New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year up to 24 months The number of new biopsy-confirmed NMSC lesions per subject per year was calculated by summarizing the total number of new BCC and SCC lesions reported over the observation period and standardizing it to an annual rate by multiplying by 365 and dividing by days on study.
- Secondary Outcome Measures
Name Time Method Time to First Biopsy Confirmed New NMSC Lesion. up to 24 months The time to first biopsy confirmed new NMSC lesion starts at 1 day post randomization to biopsy and/or treatment of newly confirmed NMSC lesion.
Number of Lesion Free Subjects up to 24 months The overall number of subjects who were lesion free were compared between treatment groups with the Cochran Mantel Haenszel test stratified by baseline NMSC stratum. Within each stratum, the Fisher exact test was used to compare the proportions of lesion free subjects between treatment groups.
Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) up to 24 months Grade Distribution of NMSC Lesions up to 24 months Number of subjects with at least 1 biopsy-confirmed new squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).
Number of Recurrent NMSC Lesions Per Subject-year up to 24 months Recurrent NMSC lesions is defined as recurring at the site of a previously treated lesion.
Subjects Reporting Incidence of Metastatic Disease Related to NMSC. up to 24 months The number of subjects with metastatic disease related to NMSC.
Death Due to NMSC up to 24 months Number of Subjects Who Discontinue Assigned Therapy up to 24 months Nankivell-Calculated Glomerular Filtration Rate (GFR) At 24 months (week 104) GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using Nankivell. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR \<15 is consistent with kidney failure.
Serum Creatinine Level At 24 months (Week 104) Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatinine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly patients typically have smaller muscle mass.
Number of Participants That Died up to 24 months Graft Survival Measured by Graft Loss up to 24 months Graft loss was defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for \>8 consecutive weeks), retransplant, or death.
Number of Subjects With Biopsy-Confirmed Acute Rejection up to 24 months Spot Urine Protein:Creatinine Ratio At 24 months (Week 104) Subjects' urine protein:creatinine ratios were summarized by each scheduled visit, and the nonparametric Wilcoxon rank sum test was used to compare the difference between groups.