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Completed

NCT Number: NCT00133887

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

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.

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Key information

Conditions

Skin Cancer Carcinoma Carcinoma, Squamous Cell Kidney Transplantation Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Edouard Herriot - Service de Dermatologie

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapamycin

Drug

3 to 5 mg/day

Other names: Rapamune

Ciclosporine

Drug

Blood residual level < or = to 125 ng/ml

Tacrolimus

Drug

Blood residual level < or = to 8 ng/ml

Primary outcomes

  1. To assess the incidence of new squamous cell carcinoma in kidney transplant recipients

    Time frame: during 5 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients - Multicentric Randomized, Open-label Study of Rapamycin vs Calcineurin Inhibitors

Important dates

Study start
2004
Primary completion
2011
Study completion
2014
First posted
Aug 24, 2005
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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