---
title: "TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients"
nct_id: NCT00133887
overall_status: COMPLETED
phase: PHASE3
sponsor: Hospices Civils de Lyon
study_type: INTERVENTIONAL
primary_condition: Skin Cancer
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00133887.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00133887"
ct_last_update_post_date: 2025-12-26
last_seen_at: "2026-05-12T07:25:48.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients

**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

**NCT ID:** [NCT00133887](https://clinicaltrials.gov/study/NCT00133887)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 77
- **Lead Sponsor:** Hospices Civils de Lyon
- **Conditions:** Skin Cancer, Kidney Transplantation
- **Start Date:** 2004-04
- **Completion Date:** 2014-05
- **CT.gov Last Update:** 2025-12-26

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **1** (EXPERIMENTAL) — patients receiving Rapamycin
- **2** (ACTIVE_COMPARATOR) — patients receiving anticalcineurin treatment

## Interventions

- **rapamycin** (DRUG) — 3 to 5 mg/day
- **ciclosporine** (DRUG) — Blood residual level \< or = to 125 ng/ml
- **tacrolimus** (DRUG) — Blood residual level \< or = to 8 ng/ml

## Primary Outcomes

- **To assess the incidence of new squamous cell carcinoma in kidney transplant recipients** _(time frame: during 5 years)_

## Secondary Outcomes

- **To assess the incidence of other non skin cancer in kidney transplant recipients** _(time frame: during 5 years)_
- **To assess the graft survival** _(time frame: during 5 years)_
- **To assess the tolerance of rapamycin** _(time frame: during 5 years)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hôpital edouard herriot - service de dermatologie|lyon||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00133887.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00133887*  
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