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


Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Skin Cancer, Kidney Transplantation

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

during 5 years

Safety Issue:

No

Principal Investigator

Sylvie EUVRARD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospices Civils de Lyon

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2003.333

NCT ID:

NCT00133887

Start Date:

April 2004

Completion Date:

March 2014

Related Keywords:

  • Skin Cancer
  • Kidney Transplantation
  • Squamous cell carcinoma
  • kidney transplant recipients
  • rapamycin
  • Skin cancers in kidney transplant recipients
  • Skin Neoplasms

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