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

July 1, 2014 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hôpital Edouard Herriot - Service de Dermatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
patients receiving Rapamycin
Drug: rapamycin
3 to 5 mg/day
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the incidence of new squamous cell carcinoma in kidney transplant recipients
Time Frame: during 5 years
during 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the incidence of other non skin cancer in kidney transplant recipients
Time Frame: during 5 years
during 5 years
To assess the graft survival
Time Frame: during 5 years
during 5 years
To assess the tolerance of rapamycin
Time Frame: during 5 years
during 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sylvie EUVRARD, MD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

August 23, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (ESTIMATE)

August 24, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2014

Last Update Submitted That Met QC Criteria

July 1, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003.333

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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