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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129961
• Other study ID #: 0468H1-407
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2005
• Last updated: April 9, 2012
• Start date: August 2005
• Est. completion date: January 2009

Study information

• Verified date: April 2012
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation
• Skin Neoplasms

Intervention

Drug:
• sirolimus

• cyclosporine or tacrolimus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 24 months	No
Secondary	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.	up to 24 months	No
Secondary	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.	up to 24 months	No
Secondary	Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC)		up to 24 months	No
Secondary	Grade Distribution of NMSC Lesions	Number of subjects with at least 1 biopsy-confirmed new squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).	up to 24 months	No
Secondary	Number of Recurrent NMSC Lesions Per Subject-year	Recurrent NMSC lesions is defined as recurring at the site of a previously treated lesion.	up to 24 months	No
Secondary	Subjects Reporting Incidence of Metastatic Disease Related to NMSC.	The number of subjects with metastatic disease related to NMSC.	up to 24 months	No
Secondary	Death Due to NMSC		up to 24 months	No
Secondary	Number of Subjects Who Discontinue Assigned Therapy		up to 24 months	No
Secondary	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.	At 24 months (week 104)	No
Secondary	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.	At 24 months (Week 104)	No
Secondary	Number of Participants That Died		up to 24 months	No
Secondary	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.	up to 24 months	No
Secondary	Number of Subjects With Biopsy-Confirmed Acute Rejection		up to 24 months	No
Secondary	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.	At 24 months (Week 104)	No