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

Phase 1

Conditions: Squamous cell carcinoma (SCC) and other malignancies in renal transplanted recipients
MedDRA version: 17.0Level: PTClassification code 10041823Term: Squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-005481-35-DK

Lead Sponsor: ppsala University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

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

Exclusion Criteria

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