Full Text View
Tabular View
No Study Results Posted
Related Studies
TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients
This study is currently recruiting participants.
Verified by Hospices Civils de Lyon, February 2009
First Received: August 23, 2005   Last Updated: February 6, 2009   History of Changes
Sponsor: Hospices Civils de Lyon
Information provided by: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00133887
  Purpose

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.


Condition Intervention Phase
Skin Cancer
Kidney Transplantation
Drug: rapamycin
Drug: ciclosporine
Drug: tacrolimus
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients - Multicentric Randomized, Open-Label Study of Rapamycin vs Calcineurin Inhibitors

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • To assess the incidence of new squamous cell carcinoma in kidney transplant recipients [ Time Frame: during 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: April 2004
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
patients receiving Rapamycin
Drug: rapamycin
3 to 5 mg/day
2: Active Comparator
patients receiving anticalcineurin treatment
Drug: ciclosporine
Blood residual level < or = to 125 ng/ml
Drug: tacrolimus
Blood residual level < or = to 8 ng/ml

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133887

Contacts
Contact: Sylvie EUVRARD, MD 33 472 110 ext 322 sylvie.euvrard@chu-lyon.fr

Locations
France
Hôpital Edouard Herriot - Service de Dermatologie Recruiting
LYON, France, 69003
Contact: Sylvie EUVRARD, MD     33 472 110 ext 322     sylvie.euvrard@chu-lyon.fr    
Principal Investigator: Sylvie EUVRARD, MD            
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Sylvie EUVRARD, MD Hospices Civils de Lyon
  More Information

Publications:
Responsible Party: Hospices Civils de Lyon ( Sylvie EUVRARD )
Study ID Numbers: 2003.333
Study First Received: August 23, 2005
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00133887     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:
Squamous cell carcinoma
kidney transplant recipients
rapamycin
Skin cancers in kidney transplant recipients

Additional relevant MeSH terms:
Sirolimus
Anti-Infective Agents
Immunologic Factors
Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Tacrolimus
Skin Neoplasms
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antifungal Agents

ClinicalTrials.gov processed this record on November 30, 2009