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TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients
This study is currently recruiting participants.
Study NCT00133887   Information provided by Hospices Civils de Lyon
First Received: August 23, 2005   Last Updated: February 6, 2009   History of Changes

August 23, 2005
February 6, 2009
April 2004
March 2014   (final data collection date for primary outcome measure)
To assess the incidence of new squamous cell carcinoma in kidney transplant recipients [ Time Frame: during 5 years ] [ Designated as safety issue: No ]
To assess the incidence of new squamous cell carcinoma in kidney transplant recipients.
Complete list of historical versions of study NCT00133887 on ClinicalTrials.gov Archive Site
  • To assess the incidence of other non skin cancer in kidney transplant recipients [ Time Frame: during 5 years ] [ Designated as safety issue: No ]
  • To assess the graft survival [ Time Frame: during 5 years ] [ Designated as safety issue: No ]
  • To assess the tolerance of rapamycin [ Time Frame: during 5 years ] [ Designated as safety issue: Yes ]
  • To assess the incidence of other non skin cancer in kidney transplant recipients.
  • To assess the graft survival
  • To assess the tolerance of rapamycin
 
TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients
Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients - Multicentric Randomized, Open-Label Study of Rapamycin vs Calcineurin Inhibitors

In a population of kidney transplant recipients having developed a first squamous cell carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2 years in patients who are switched to rapamycin as compared to patients who are maintained under calcineurin inhibitors.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Skin Cancer
  • Kidney Transplantation
  • Drug: rapamycin
  • Drug: ciclosporine
  • Drug: tacrolimus
  • Experimental: patients receiving Rapamycin
  • Active Comparator: patients receiving anticalcineurin treatment

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
120
 
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Sylvie EUVRARD, MD 33 472 110 ext 322 sylvie.euvrard@chu-lyon.fr
France
 
NCT00133887
Sylvie EUVRARD, Hospices Civils de Lyon
2003.333
Hospices Civils de Lyon
 
Principal Investigator: Sylvie EUVRARD, MD Hospices Civils de Lyon
Hospices Civils de Lyon
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP