Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
0
0
0468H1-407
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Skin Neoplasms
0
0
Query!
Kidney Transplantation
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Malignant melanoma
Query!
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Experimental: 1 - Conversion to a sirolimus-based regimen
Active comparator: 2 - Continuation of a CNI-based regimen
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
up to 24 months
Query!
Secondary outcome [1]
0
0
Time to First Biopsy Confirmed New NMSC Lesion.
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
up to 24 months
Query!
Secondary outcome [2]
0
0
Number of Lesion Free Subjects
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
up to 24 months
Query!
Secondary outcome [3]
0
0
Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC)
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
up to 24 months
Query!
Secondary outcome [4]
0
0
Grade Distribution of NMSC Lesions
Query!
Assessment method [4]
0
0
Number of subjects with at least 1 biopsy-confirmed new squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).
Query!
Timepoint [4]
0
0
up to 24 months
Query!
Secondary outcome [5]
0
0
Number of Recurrent NMSC Lesions Per Subject-year
Query!
Assessment method [5]
0
0
Recurrent NMSC lesions is defined as recurring at the site of a previously treated lesion.
Query!
Timepoint [5]
0
0
up to 24 months
Query!
Secondary outcome [6]
0
0
Subjects Reporting Incidence of Metastatic Disease Related to NMSC.
Query!
Assessment method [6]
0
0
The number of subjects with metastatic disease related to NMSC.
Query!
Timepoint [6]
0
0
up to 24 months
Query!
Secondary outcome [7]
0
0
Death Due to NMSC
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
up to 24 months
Query!
Secondary outcome [8]
0
0
Number of Subjects Who Discontinue Assigned Therapy
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
up to 24 months
Query!
Secondary outcome [9]
0
0
Nankivell-Calculated Glomerular Filtration Rate (GFR)
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
At 24 months (week 104)
Query!
Secondary outcome [10]
0
0
Serum Creatinine Level
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
At 24 months (Week 104)
Query!
Secondary outcome [11]
0
0
Number of Participants That Died
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
up to 24 months
Query!
Secondary outcome [12]
0
0
Graft Survival Measured by Graft Loss
Query!
Assessment method [12]
0
0
Graft loss was defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for \>8 consecutive weeks), retransplant, or death.
Query!
Timepoint [12]
0
0
up to 24 months
Query!
Secondary outcome [13]
0
0
Number of Subjects With Biopsy-Confirmed Acute Rejection
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
up to 24 months
Query!
Secondary outcome [14]
0
0
Spot Urine Protein:Creatinine Ratio
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
At 24 months (Week 104)
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/08/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/01/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
86
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Query!
Recruitment hospital [1]
0
0
- Camperdown
Query!
Recruitment hospital [2]
0
0
- Wooloongabba
Query!
Recruitment hospital [3]
0
0
- Woodville
Query!
Recruitment hospital [4]
0
0
- Adelaide
Query!
Recruitment hospital [5]
0
0
- Clayton
Query!
Recruitment hospital [6]
0
0
- Herston
Query!
Recruitment hospital [7]
0
0
- Parkville
Query!
Recruitment hospital [8]
0
0
- Randwick
Query!
Recruitment hospital [9]
0
0
- Westmead
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
4102 - Wooloongabba
Query!
Recruitment postcode(s) [3]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [4]
0
0
SA 5000 - Adelaide
Query!
Recruitment postcode(s) [5]
0
0
VIC 3169 - Clayton
Query!
Recruitment postcode(s) [6]
0
0
QLD 4029 - Herston
Query!
Recruitment postcode(s) [7]
0
0
VIC 3050 - Parkville
Query!
Recruitment postcode(s) [8]
0
0
NSW 2031 - Randwick
Query!
Recruitment postcode(s) [9]
0
0
NSW 2145 - Westmead
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
North Carolina
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Ohio
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Oregon
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Pennsylvania
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
South Carolina
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Tennessee
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Wisconsin
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
British Columbia
Query!
Country [13]
0
0
New Zealand
Query!
State/province [13]
0
0
Auckland
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00129961
Query!
Trial related presentations / publications
Campbell SB, Walker R, Tai SS, Jiang Q, Russ GR. Randomized controlled trial of sirolimus for renal transplant recipients at high risk for nonmelanoma skin cancer. Am J Transplant. 2012 May;12(5):1146-56. doi: 10.1111/j.1600-6143.2012.04004.x. Epub 2012 Mar 15.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Monitor
Query!
Address
0
0
Wyeth is now a wholly owned subsidiary of Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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
Download to PDF