A controlled, randomized, assessor blinded, open-label study to investigate whether initiation of everolimus will reduce the incidence of developing a new Squamous Cell Carcinoma (SCC) and other malignancies in Renal Transplanted Recipients with at least one SCC during the last 2 years - SCANDINAVIAN EVEROLIMUS SQUAMOUS CELL CARCINOMA STUDY (SESAM)

ppsala University Hospital0 个研究点目标入组 220 人开始时间: 2013年9月2日最近更新: 2017年7月24日

适应症

试验速览

暂无简介。

•1. Male or female kidney transplant recipients or combined kidney/pancreas transplant recipients aged 18 years or older
•2. Patient transplanted at least 12 months prior to enrollment/inclusion
•3. Patient has experienced at least one SCC (per definition, SCC includes SCC in situ (Mb Bowen) and keratoacanthoma (KA) like SCC) within the last 2 years
•4. Patients receiving a standard immunosuppressive treatment with CNI, +/- mycophenolate acid (MPA), +/- steroids and/or +/- azathioprine (AZA)
•5. Patient willing and capable of giving written informed consent for study participation
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 132
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 88

•1. Patients with any present malignancy (other than SCC, basal cell carcinoma or melanoma skin cancer; thickness = 1 mm)
•2. Patients who have received an unlicensed drug or therapy within one month prior to study entry or if such therapy is to be instituted post-transplantation
•3. Patients with an eGFR (MDRD formula) of < 20 mL/min
•4. Patients with on-going treatment for rejection
•5. Patients with a hemoglobin count < 8.0 g/dL (5.0 mmol/L); and/or a platelet count < 50x10^9/L and/or white blood cell count = 2.5x10^9/L
•6. Patients with total cholesterol (TC) = 9 mmol/L and/or triglycerides (TG) = 6 mmol/L despite lipid lowering treatment
•7. Patients with a spot urinary albumin/creatinine ratio = 50 mg/mmol
•8. Patient with a current clinically severe systemic infection
•9. Patients treated with everolimus or sirolimus within the past 12 months
•10. Patients unable to participate in the study for the full 24-months period
•11. Female patients of childbearing potential not able to present a negative pregnancy test prior to randomization
•12. Nursing mothers
•13.Known hypersensitivity to any of the study drugs (or excipients) or to macrolides
•14.Patients with high immunological risk profile

发起方

ppsala University Hospital