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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Experimental: 1 - Conversion to a sirolimus-based regimen

Active comparator: 2 - Continuation of a CNI-based regimen
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00129961