Squamous cell carcinoma (SCC) and other malignancies in renal transplanted recipients MedDRA version: 17.0 Level: PT Classification code 10041823 Term: Squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Certican "Novartis", one tablet containing 0.25, 0.5, 0.75 and 1 mg.
Product Name: Certican "Novartis"
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
CAS Number: 159351-69-6
Sponsors
Uppsala University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate whether initiation of everolimus and discontinuation/ minimization of calcineurin inhibitors (CNI) in maintenance renal transplant patients with at least one earlier diagnosed SCC incident within the last two years prior to inclusion, will reduce the risk of new SCC incidents (per definition, SCC includes SCC in situ (Mb Bowen) and keratoacanthoma (KA) like SCC).;Secondary Objective: • Compare time to first SCC event between the two groups (Kaplan Meyer of SCC survival time) • To compare the risk of developing SCCs at 24 months • To compare the risk of developing new skin cancers except SCC at 24 months • To compare the risk of developing cancer except skin cancer at 24 months • To compare the rate of biopsy proven acute rejections (BPAR) at 24 months • To compare patient and graft survival at 24 months • To compare estimated glomerular filtration rate (eGFR) using Modification of Diet in Renal Disease (MDRD) formula between the two groups at 24 months • To compare adverse event rates • To compare rates of incidence and type of infections ;Primary end point(s): The primary endpoint is the proportion of patients who developed at least one new SCC during the 24 month study period. ;Timepoint(s) of evaluation of this end point: Suspected new SCCs will be assessed at least every 6 months or by indication during a period of 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Suspected new skin cancers; Skin biopsy to be performed according to standard procedure and parameteres to be recorded are type of malignant skin cancer, SCC in situ (Mb Bowen), and Actinictic keratosis. 2. New malignancies exept skin cancers 3. Renal function analysed as eGFR ( Modification of Diet in Renal Disease formula) 4. Acute rejection episodes 5. Graft loss (suspected if the patient start dialysis and is not subsequently to be removed) 6. Adverse events rates 7. Rates of incidence and types of infections 6. Patient survival ;Timepoint(s) of evaluation of this end point: These end points will be assessed at the following timepoints; 1. At visit 2 (baseline), and visit 7-11 or at least every 3-6 months. Suspected new SCC incidents will be assessed by indication (if applicable). 2. At visit 2 - visit 11. 3. At visit 1 (enrollment visit) - visit 11. 4. At visit 3-11 (if applicable) 5. At visit 3-11 (if applicable) 6. At visit 2-11 7. At visit 3-11 (if applicable) 6. At visit 11 (24 months) | — |
Countries
Denmark
Contacts
Public ContactMinda Halkinrud
Smerud Medical Research
Outcome results
None listed