TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00133887
First received: August 23, 2005
Last updated: July 1, 2014
Last verified: May 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Enrollment: 77
Study Start Date: April 2004
Study Completion Date: May 2014
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patients receiving Rapamycin
Drug: rapamycin
3 to 5 mg/day
Other Name: Rapamune
Active Comparator: 2
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00133887

Locations
France
Hôpital Edouard Herriot - Service de Dermatologie
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Sylvie EUVRARD, MD Hospices Civils de Lyon
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00133887     History of Changes
Other Study ID Numbers: 2003.333
Study First Received: August 23, 2005
Last Updated: July 1, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on October 02, 2014