Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT00129961|
Recruitment Status : Completed
First Posted : August 12, 2005
Results First Posted : March 23, 2012
Last Update Posted : April 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Skin Neoplasms Kidney Transplantation||Drug: sirolimus Drug: cyclosporine or tacrolimus||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2005|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
Conversion to a sirolimus-based regimen
Active Comparator: 2
Continuation of a CNI-based regimen
Drug: cyclosporine or tacrolimus
- New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year [ Time Frame: 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.
- Time to First Biopsy Confirmed New NMSC Lesion. [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: up to 24 months ]
- Grade Distribution of NMSC Lesions [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: up to 24 months ]The number of subjects with metastatic disease related to NMSC.
- 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to 24 months ]
- Graft Survival Measured by Graft Loss [ Time Frame: 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 [ Time Frame: up to 24 months ]
- Spot Urine Protein:Creatinine Ratio [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129961
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|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|
|Principal Investigator:||Trial Manager||For Canada, firstname.lastname@example.org|
|Principal Investigator:||Trial Manager||For Australia, email@example.com|
|Principal Investigator:||Trial Manager||For New Zealand, firstname.lastname@example.org|