PROSKINPrevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Sirolimus
Prevention Study
Summary
Study start date: March 1, 2007
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
No InterventionStudy Objectives
Primary Objectives