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

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ClinicalTrials.gov Identifier: NCT00133887
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
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 or disease Intervention/treatment Phase
Skin Cancer Kidney Transplantation Drug: rapamycin Drug: ciclosporine Drug: tacrolimus Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2004
Primary Completion Date : March 2011
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. To assess the incidence of new squamous cell carcinoma in kidney transplant recipients [ Time Frame: during 5 years ]

Secondary Outcome Measures :
  1. To assess the incidence of other non skin cancer in kidney transplant recipients [ Time Frame: during 5 years ]
  2. To assess the graft survival [ Time Frame: during 5 years ]
  3. To assess the tolerance of rapamycin [ Time Frame: during 5 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: July 2, 2014
Last Verified: May 2014

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
Tacrolimus
Sirolimus
Everolimus
Cyclosporins
Cyclosporine
Calcineurin Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Dermatologic Agents
Antirheumatic Agents