Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol - Clinical Trial for Renal Transplant Patients at High-risk for Skin Cancer | NCT01797315

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Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Sirolimus

About this trial

This is an interventional prevention trial for Renal Transplant Patients at High-risk for Skin Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Sirolimus

Standard therapy

Arm Description

Patients who meet all inclusion criteria will be included into the study and randomised. If converted to Sirolimus (SRL), patients will take SRL according to the investigator's instructions and medication label, once daily preferably 4 hours after calcineurin-inhibitor medication or in case without calcineurin-inhibitor co-medication in the morning. The dose of SRL will be correlated to the former immunosuppressive therapy according to the study's conversion protocol.

Patients who will not receive SRL stay on their previous immunosuppressive therapy including one or more of the following drugs: azathioprine, cyclosporine, tacrolimus, mycophenolate-sodium and steroids.

Outcomes

Primary Outcome Measures

Progression of actinic keratosis or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors

Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen's disease, precancerous keratoses, actinic keratoses III)