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Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol

NCT00866684 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-03-14

Study results available
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Summary

Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves (i.e., azathioprine) and relates on the other hand on the dosage (i.e., calcineurin-inhibitors). Based on the encouraging results of previous, retrospective studies on patients treated with Sirolimus (SRL), these patients should be switched to an immunosuppressive regime including SRL, decreasing the dosage of calcineurin-inhibitors or converting from former immunosuppression. A conversion to a SRL-based therapy is effective in immunosuppression and safe regarding graft and patient survival.

This study was designed to assess whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurrence of skin neoplasm.

Conditions

Interventions

DRUG

Sirolimus

Treatment arm Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day

DRUG

Azathioprine

control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month

DRUG

Mycophenolate

Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month

DRUG

Ciclosporin

Control arm Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month

DRUG

Tacrolimus

Control arm Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Petra Reinke, Prof. Dr. · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-01
Primary Completion
2011-04-19
Completion
2011-04-19

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00866684 on ClinicalTrials.gov