Health Condition 1: null- Renal Transplantation
Conditions
Interventions
Intervention1: Everolimus: 6 to 10 ng/ml(target dose given by PI)Twice a day orally at 12-hour intervals for 22 months.
in combination with mycophenolate sodium and steroids
Control Intervention1: Tac
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria at Baseline: Male or female renal allograft recipients at least 18 years old. Written informed consent. Patient receiving a primary or secondary kidney transplant from a cadaveric or living unrelated-/related donor. Cold ischemia time (CIT) less than 24 hours. Negative pregnancy test for female patients. Inclusion Criteria at Randomization: Patients on CNI (TAC or CsA) + Myfortic + steroids. Serum creatinine less than 2.8 mg/dL (250 mol/L) and an actual eGFR (MDRD4)greater than or equal to 25 mL/min/1.73m exp2 (without renal replacement therapy).
Exclusion criteria
Exclusion criteria: Exclusion Criteria at Baseline: 1)Patients fulfilling any of the following criteria are not eligible for inclusion in this study: 2)Recipient of multiple organ transplants. 3)Recipient of ABO incompatible allograft or a positive cross-match. 4)Panel Reactive Antibodies (PRA) level greater than equal to 30 %. 5)Positive test for human immunodeficiency virus (HIV). 6)Patient receiving an allograft from a Hepatitis B surface Antigen (HBsAg) or a Hepatitis C Virus (HCV) positive donor. 7)HBsAg and/or a HCV positive patient with evidence of elevated LFTs (ALT/AST levels greater than equal to 2.5 times ULN). 8)Severe restrictive or obstructive pulmonary disorders. 9)Patient with severe allergy requiring acute or chronic treatment or hypersensitivity to any of the study drugs or similar drugs. 10)Severe hypercholesterolemia or hypertriglyceridemia. 11)Low platelet count. 12)Low white blood cell count. 13)History of malignancy of any organ system Exclusion Criteria at Randomization: 14)Graft loss. 15)Patient on renal replacement therapy. 16)Patient who experienced severe humoral and/or cellular rejection (BANFF greater than equal to IIb). 17)Patient with greater than equal to 2 episodes of AR or an AR episode that needed antibody treatment. 18)Patient with ongoing or currently treated AR (2 weeks prior to randomization). 19)Proteinuria greater 1 g/day. 20)Patients with recurrence of Focal Segmental Glomerulosclerosis (FSGS). 21)Low platelet count; Low white blood cell count; Low absolute neutrophil count; Low hemoglobin. 22)Severe liver disease. 23)Systemic infection requiring continued therapy that would interfere with the objectives of the study. 24)Severe hypercholesterolemia or hypertriglyceridemia. 25)Patients with ongoing wound healing problems, clinically significant infection requiring continued therapy. 26)Presence of intractable immunosuppressant complications or side effects. 27)Patients on anticoagulants that prevents renal allograft biopsy. 28)Use of prohibited medication. 29)Use of immunosuppressive agents not utilized in the protocol. 30)Pregnant or nursing (lactating) women. 31)Women of child-bearing potential not using a highly effective method of birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of renal function by estimated Glomerular Filtration RateTimepoint: Time Frame: at 12 months post-transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Composite efficacy failure as treated biopsy proven acute rejection (BPAR ), graft loss or death Timepoint: 1)Time Frame: at 12 months post-transplantation ;2)Improvement of Left Ventricular Hypertrophy (LVH) as assessed by LV mass index (LVMi) using echocardiogramTimepoint: 2)Time Frame: at 12 months post-transplantation.;3)Incidence, time to event and severity of treated BPAR greater than equal to IB; incidence of BPAR that need antibody treatment; incidence of humoral rejection; incidence of treated BPAR greater than equal to IB.Timepoint: 3)Time Frame: at 12 and 24 months post-transplantation.;4)Incidence, time to event and severity of any acute rejection (suspected AR, treated acute AR, Biopsy AR, treated biopsy proven AR, subclinical AR).Timepoint: 4)Time Frame: at 12 and 24 months post-transplantation .;5)Incidence of adverse events (AEs) and serious adverse events (SAEs)Timepoint: 5)Time Frame: at 12 and 24 months post-transplantation. | — |
Countries
Germany, India
Contacts
Public ContactMurugananthan K
Outcome results
None listed