Renal transplantation MedDRA version: M15 Classification code 10023438
Conditions
Interventions
Product Name: Certican
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
INN or
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patient at least 18 years of age. Patient who have undergone a primary or secondary renal transplant at least 6 months previous from a living related or unrelated donor or a cadaveric donor. Patient receiving Neoral® with a C2-h level = 400 ng/mL or Prograf® with a C0-h level = 4 ng/mL in combination with or without MPA or AZA plus or minus steroids. Patient with renal impairment defined as measured GFR between 30 and 70 mL/min/1.73m2. (For Sweden: Patients with GFR 60-70 mL/min a documented reduction of t least 10 % in GFR as compared to the best post-transplant GFR is required) Patient in whom an allograft biopsy is not contraindicated. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient recipient of multiple organ transplants. Patient with protein/creatinine ratio = 150 mg/mmol. Patient with an acute rejection episode within the last 3 months. Patient with any past or present BK-polyomavirus nephropathy. Patient with de novo or recurrent glomerular nephritis. Patient with a platelet count of < 50,000/mm3 or with a white blood cell count of = 2,500/mm3 or with a hemoglobin value < 8 g/dL. Presence of severe hypercholesterolemia (= 350 mg/dL or =9.1 mmol/L) or hypertriglyceridemia (= 750 mg/dL or =8.55 mmol/L). Patient being currently treated or who has been treated with a mTOR inhibitor. Patient who had received an investigational drug within 4 weeks. Patient who is human immunodeficiency virus (HIV) positive or who has a current severe systemic infection according to the investigator judgment requiring continued therapy. Present use of any other immunosuppressive drugs than Neoral®/Prograf® , MPA/AZA and steroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate whether initiation of everolimus together with reduction or discontinuation of CNI in maintenance renal transplant patients with renal impairment will improve renal function. This will be assessed by comparing renal function evaluated by measured glomerular filtration rate among 3 groups of patients at month 24.;Secondary Objective: To compare patient and graft survival at 24 months. To compare the progression of chronic allograft nephropathy . To compare the progression of atherosclerosis assessed by carotid artery ultrasonography Doppler examinations (intima-media thickness (IMT)) at 24 months. To compare mGFR between Group B and Group C at 24 months. To compare other renal function data: slopes of serum creatinine (Cr) and slopes of its reciprocal (1/Cr) and calculated creatinine clearance (Cockcroft-Gault and Nankivell formula) over 24 months study duration. To compare the number and severity of biopsy proven acute rejections at 24 months. To compare safety parameters including incidence of hypertension, hyperlipidemia, diabetes mellitus, anemia, leucopenia, thrombocytopenia, malignancies and infections at 24 months. To summarize everolimus C-0h, Neoral® C-2h and Prograf® C-0h over the 24 months.;Primary end point(s): The primary objective will be assessed by comparing the renal function as assessed by measured GFR at 24 months among the 3 groups of patients: • Group A: current immunosuppressive regimen continuation (Control arm) • Group B: initiation of everolimus (8-12 ng/mL) with discontinuation of CNI (Test arm) • Group C: initiation of everolimus (3 - 8 ng/mL) with reduction by 70-90 % in CNI blood levels (Test arm). That is, the primary objective is to show either Group B or Group C will be superior to control Group A with respect to mean mGFR at 24 months. | — |
Countries
Czech Republic, Denmark, Finland, Hungary, Italy, Spain, Sweden
Outcome results
None listed