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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00129961




Registration number
NCT00129961
Ethics application status
Date submitted
1/08/2005
Date registered
12/08/2005
Date last updated
11/04/2012

Titles & IDs
Public title
Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
Scientific 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
Secondary ID [1] 0 0
0468H1-407
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Neoplasms 0 0
Kidney Transplantation 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - sirolimus
Treatment: Drugs - cyclosporine or tacrolimus

Experimental: 1 - Conversion to a sirolimus-based regimen

Active Comparator: 2 - Continuation of a CNI-based regimen


Treatment: Drugs: sirolimus


Treatment: Drugs: cyclosporine or tacrolimus
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year
Timepoint [1] 0 0
up to 24 months
Secondary outcome [1] 0 0
Time to First Biopsy Confirmed New NMSC Lesion.
Timepoint [1] 0 0
up to 24 months
Secondary outcome [2] 0 0
Number of Lesion Free Subjects
Timepoint [2] 0 0
up to 24 months
Secondary outcome [3] 0 0
Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC)
Timepoint [3] 0 0
up to 24 months
Secondary outcome [4] 0 0
Grade Distribution of NMSC Lesions
Timepoint [4] 0 0
up to 24 months
Secondary outcome [5] 0 0
Number of Recurrent NMSC Lesions Per Subject-year
Timepoint [5] 0 0
up to 24 months
Secondary outcome [6] 0 0
Subjects Reporting Incidence of Metastatic Disease Related to NMSC.
Timepoint [6] 0 0
up to 24 months
Secondary outcome [7] 0 0
Death Due to NMSC
Timepoint [7] 0 0
up to 24 months
Secondary outcome [8] 0 0
Number of Subjects Who Discontinue Assigned Therapy
Timepoint [8] 0 0
up to 24 months
Secondary outcome [9] 0 0
Nankivell-Calculated Glomerular Filtration Rate (GFR)
Timepoint [9] 0 0
At 24 months (week 104)
Secondary outcome [10] 0 0
Serum Creatinine Level
Timepoint [10] 0 0
At 24 months (Week 104)
Secondary outcome [11] 0 0
Number of Participants That Died
Timepoint [11] 0 0
up to 24 months
Secondary outcome [12] 0 0
Graft Survival Measured by Graft Loss
Timepoint [12] 0 0
up to 24 months
Secondary outcome [13] 0 0
Number of Subjects With Biopsy-Confirmed Acute Rejection
Timepoint [13] 0 0
up to 24 months
Secondary outcome [14] 0 0
Spot Urine Protein:Creatinine Ratio
Timepoint [14] 0 0
At 24 months (Week 104)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2009
Sample size
Target
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Wooloongabba
Recruitment hospital [3] 0 0
- Woodville
Recruitment hospital [4] 0 0
- Adelaide
Recruitment hospital [5] 0 0
- Clayton
Recruitment hospital [6] 0 0
- Herston
Recruitment hospital [7] 0 0
- Parkville
Recruitment hospital [8] 0 0
- Randwick
Recruitment hospital [9] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4102 - Wooloongabba
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment postcode(s) [4] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [5] 0 0
VIC 3169 - Clayton
Recruitment postcode(s) [6] 0 0
QLD 4029 - Herston
Recruitment postcode(s) [7] 0 0
VIC 3050 - Parkville
Recruitment postcode(s) [8] 0 0
NSW 2031 - Randwick
Recruitment postcode(s) [9] 0 0
NSW 2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
New Zealand
State/province [13] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00129961
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries