PROSKINPrevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Sirolimus
Étude de prévention
Résumé
Date de début de l'étude : 1 mars 2007
Date à laquelle le premier participant a commencé l'étude.Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves and relates on the other hand on the dosage. 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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.40 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
Inclusion Criteria: Recipients of renal allograft with current actinic keratosis I or II or successfully treated actinic keratosis III (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell carcinoma age 18 years and older minimum period of 6 month after renal transplantation stable renal function and a calculated creatinine clearance of at least 40 ml/min written informed consent proteinuria ≤ 800 mg/d at time of enrolment successfully treated solid tumor (no recurrence or metastasis in the last 2 years) Exclusion Criteria: Current Sirolimus- or Everolimus- intake Instable graft function (creatinine clearance < 40 ml/min) Graft rejection within the 3 previous months Proteinuria > 800 mg/d Non-controlled hyperlipidemia (Cholesterol >7,8 mmol/l (300 mg/dl), Triglycerides > 4 mmol/l (350 mg/dl) Leucopenia < 2500/nl Thrombocytopenia < 90/nl Pregnancy or breastfeeding Women of childbearing age without highly effective contraception Known allergy to macrolides Current participation in other studies Refusal to sign informed consent form Neoplasm other than defined as inclusion criteria All contraindications to SRL (see package insert, appendix) Persons who are detained officially or legally to an official institute Acute infections (mycotic, viral or bacterial) Current intake of other substances with known nephrotoxicity Severe liver dysfunction Current intake of CY3A4-inhibitors (e.g. ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or CY3A4-inductors (rifampicin, rifabutin) sucrose-isomaltase deficiency, fructose intolerance, glucose-galactose intolerance azathioprine: known allergy to azathioprine or 6-mercaptopurine, severe bone marrow dysfunction, pancreatitis, vaccination with live vaccine tacrolimus: known allergy to tacrolimus mycophenolatmofetil: known allergy to mycophenolatmofetil, neutropenia, severe active gastrointestinal tract disease, Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome, current intake of azathioprine cyclosporine: known allergy to cyclosporine, increased intracranial pressure
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Comparateur actifGroupe II
Pas d'interventionObjectifs de l'étude
Objectifs principaux