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

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation; Skin Cancer

Treatments: Drug: ciclosporine; Drug: rapamycin; Drug: tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT00133887

2003.333

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

1

Experimental group

Description:

patients receiving Rapamycin

Treatment:

Drug: rapamycin

2

Active Comparator group

Description:

patients receiving anticalcineurin treatment

Treatment:

Drug: tacrolimus

Drug: ciclosporine