Renal Transplantation MedDRA version: 9.1 Level: LLT Classification code 10023438 Term: Kidney transplant
Conditions
Sponsors
Novartis Pharma Services
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female above 18 year first or second renal transplant receipients willing and capable of giving written informed consent at randomisation: maintained on a triple immunosuppresive regime completed period 1 without experiencing biopsy proven acute rejection negative pregnancy test and on medically approved birth control metod 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: recipients of multi organ transplants PRA >30% receiving renal transplant from HLA-identical sibling past or present malignancy receipients of ABO incompatible transplants at randomisation: graft loss hemoglobin count 150 mg/mmol requiring dialysis and/or having a cGFR <20ml/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX);Secondary Objective: • progression of CAN at 12 and 36 months • progression of renal function by mGFR at 36 months after renal TX • progression of renal function estimated by cGFR at each follow-up visit (slope of cGFR throughout the study) • efficacy (biopsy proven acute rejection (BPAR), graft loss or death) by 12, 24 and 36 months • occurrence of treatment failures up to or at 12, 24 and 36 months • time to first diagnosed malignancy • development and magnitude of proteinuria • percentage of patients on and number of antihypertensive and lipid lowering drugs at randomization, 12, 24 and 36 months • lipid profile at 12, 24 and 36 months, at selected centers • safety and tolerability * the impact of treatment on health related quality of life. (QoL) ;Primary end point(s): assessing the difference in renal function evaluated by measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX)and at 36 months development of CAN rejection episodes proteinuria time to first diagnosed malignancy | — |
Countries
Denmark, Sweden
Outcome results
None listed