A randomised feasibility trial on the minimisation of immunosuppression in elderly renal transplant recipients
Kidney transplant recipients
In Arm 1: standard of care Immunosuppression (SOC-IS) therapy serum tacrolimus level: target tacrolimus levels 8-12ng/ml in the first 3 months target tacrolimus levels 6-8ng/ml in months 4-12 target tacrolimus level 4-8ng/ml after the 1st year Mycophenolate mofetil dose: 2g/day for 1 month 1.5mg/day between months 2-12 1g/day after the 1st year In Arm 2: minimised immunosuppression (Min-IS) therapy serum tacrolimus level : target tacrolimus levels 6-8ng/ml for first 3 months target tacrolimus levels 4-8ng/ml in months 4-12. Mycophenolate mofetil dose: 1.5g/day in the first month 1g/day until 1year post-transplantation *The intervention/treatment is reduction of both standard Tacrolimus & Mycophenolate mofetil doses.
1. First time adult recipients of either a deceased or living donor kidney transplant 2. Recipient of a single organ transplant only 3. Age above 60 years 4. Negative screen for donor-specific antibody prior to transplantation (MFI<2000)
1. Recipients that are highly sensitised (cRF >85%) 2. Inability to participate in frequent monitoring of renal transplant function and clinical visits (every 4 weeks) during dd-cfDNA monitoring and IS minimisation. 3. Immune-mediated renal disease in which IS minimisation is inadvisable 4. EBV IgG negative recipient (as IS minimisation is part of standard protocol) 5. Inability to comply with study directed treatment