Kidney transplantation Surgery
Conditions
Interventions
For the first 3 months following kidney transplantation, participants will be randomised to:
Trial arm 1: Mycophenolate mofetil (MMF) 1 g/day OR
Trial arm 2: MMF 1.5 g/day
Participants in both arms
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: Individuals aged =65 years at the time of deceased-donor kidney only transplantation
Exclusion criteria
Exclusion criteria: 1. Previous severe reaction to MMF 2. Simultaneous dual-organ transplantation (e.g., kidney and pancreas) 3. Individuals lacking the mental capacity to consent to participation 4. Immunologically incompatible transplantation 5. Use of a T-cell depleting induction agent 6. Steroid free, rapid steroid weaning or steroid sparing regimens
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment: % of those eligible and approached who consent to randomisation at invitation (assessed at invitation/baseline) 2. Adherence: % of participants concordant with allocated treatment and reason for non-concordance (assessed at 3 months) 3. Retention: % of participants who do not withdraw from trial follow-up assessments (assessed at 3 and 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Size of the eligible population (n) assessed at screening 2. Acceptability of intervention and trial methods assessed through qualitative interviews at multiple timepoints not pre-specified 3. Barriers and facilitators to intervention implementation in different settings measured by time to green light at each site and time to the recruitment of the first participant. 4. Participant and healthcare professional adherence to the intervention/trial and deviation from treatment allocation assessed through medical records of received medication at 3 months, and through qualitative interviews in parallel to trial delivery at multiple timepoints not pre-specified | — |
Countries
United Kingdom
Outcome results
None listed