renal transplant
Conditions
Interventions
investigational material(s)
Generic name etc : Everolimus
INN of investigational material : -
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investig
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject randomized within 24 hr of completion of transplant surgery. 2. Recipient of a kidney with a cold ischemia time < 30 hr. 3. Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased heart beating, living unrelated, living related non-human leukocyte antigen identical or an expanded criteria donor.
Exclusion criteria
Exclusion criteria: 1. Subject unable to tolerate oral medication at randomization. 2. Use of other investigational drugs at the time of enrollment, or within 30 days or five half-lives of enrollment, whichever is longer. 3. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. 4. Subject is a multi-organ transplant recipient. 5. Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant. 6. Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity. 7. Subject who is HIV positive. 8. HBsAg and/or a HCV positive subject with evidence of elevated LFTs (ALT/AST levels more than or equal to 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable. 9. Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV). 10. Subject with a BMI greater than 35. 11. Subject with severe systemic infections, current or within the two weeks prior to randomization. 12. Subject requiring systemic anticoagulation that cannot be temporarily interrupted and which would preclude renal biopsy. 13. History of malignancy . 14. Subject with severe restrictive or obstructive pulmonary disorders. 15. Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled. 16. Subject with white blood cell (WBC) count less than or equal to 2,000 /mm3 or with platelet count less than or equal to 50,000 /mm3. 17. Pregnant or nursing (lactating) women. 18. Women of child-bearing potential, unless they are using effective methods of contraception during dosing of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50 mL/min/1.73m2 Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50 mL/min/1.73m2 at Month 12 post-transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy safety Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death at Month 24. safety efficacy Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2 Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2 at Month 12 and 24. safety efficacy Incidence of failure on the composite endpoint of graft loss or death Incidence of failure on the composite endpoint of graft loss or death at Month 12 and 24. safety efficacy Incidence of death, graft loss, tBPAR, BPAR, tAR, AR and humoral rejection Incidence of death, graft loss, tBPAR, BPAR, tAR, AR and humoral rejection at Month 12 and 24. efficacy Incidence of eGFR < 50 mL/min/1.73m2 Incidence of eGFR < 50 mL/min/1.73m2 at Month 12 and 24. efficacy Renal allograft function (mean estimated glomerular filtration rate, eGFR) and mean change in renal allograft function from Month 1 Renal allograft function (mean estimated glomerular filtration rate, eGFR) and mean change in renal allograft function from Month 1 at Month 12 and 24. efficacy Rate of change of renal function, as eGFR, over time by slope analysis. Evolution of renal function, as eGFR, over time by slope analysis. efficacy Mean Renal function by eGFR or ceatinine clearance Cystatin C-based and other alternate formulae (e.g. CKD-EPI). Renal function by Cystatin C-based and other alternate formulae (e.g. CKD-EPI). safety Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation. Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation. safety Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhi | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed