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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
86
Unnamed facility
San Diego, California, United States
Unnamed facility
San Francisco, California, United States
New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year
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.
Time frame: up to 24 months
Time to First Biopsy Confirmed New NMSC Lesion.
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.
Time frame: up to 24 months
Number of Lesion Free Subjects
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.
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
Grade Distribution of NMSC Lesions
Number of subjects with at least 1 biopsy-confirmed new squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).
Time frame: up to 24 months
Number of Recurrent NMSC Lesions Per Subject-year
Recurrent NMSC lesions is defined as recurring at the site of a previously treated lesion.
Time frame: up to 24 months
Subjects Reporting Incidence of Metastatic Disease Related to NMSC.
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Unnamed facility
Gainesville, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Durham, North Carolina, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Portland, Oregon, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
Charleston, South Carolina, United States
...and 13 more locations
The number of subjects with metastatic disease related to NMSC.
Time frame: up to 24 months
Death Due to NMSC
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)
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.
Time frame: At 24 months (week 104)
Serum Creatinine Level
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.
Time frame: At 24 months (Week 104)
Number of Participants That Died
Time frame: up to 24 months
Graft Survival Measured by Graft Loss
Graft loss was defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for \>8 consecutive weeks), retransplant, or death.
Time frame: up to 24 months
Number of Subjects With Biopsy-Confirmed Acute Rejection
Time frame: up to 24 months
Spot Urine Protein:Creatinine Ratio
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.
Time frame: At 24 months (Week 104)