|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00133887 |
|
Date of registration:
|
23/08/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients
|
|
Scientific title:
|
Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients - Multicentric Randomized, Open-label Study of Rapamycin vs Calcineurin Inhibitors |
|
Date of first enrolment:
|
April 2004 |
|
Target sample size:
|
77 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00133887 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Sylvie EUVRARD, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hospices Civils de Lyon |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- First post-transplant squamous cell carcinoma in a kidney transplant recipient under
calcineurin inhibitors
Exclusion Criteria:
- Other squamous cell carcinomas in the past history
- More than 2 transplantations
- Patients not under calcineurin inhibitors
- Unstable graft function
- Non controlled hyperlipidemia (cholesterol > 7.8 mmol/l or triglycerides > 3.95
mmol/l)
- Leucopenia < 3000/mm3
- Thrombocytopenia < 100,000/mm3
- Liver dysfunction
- Pregnancy
- Allergy to macrolides
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Kidney Transplantation
|
|
Skin Cancer
|
|
Intervention(s)
|
|
Drug: tacrolimus
|
|
Drug: ciclosporine
|
|
Drug: rapamycin
|
|
Primary Outcome(s)
|
|
To assess the incidence of new squamous cell carcinoma in kidney transplant recipients
[Time Frame: during 5 years]
|
|
Secondary Outcome(s)
|
|
To assess the graft survival
[Time Frame: during 5 years]
|
|
To assess the tolerance of rapamycin
[Time Frame: during 5 years]
|
|
To assess the incidence of other non skin cancer in kidney transplant recipients
[Time Frame: during 5 years]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|