Transplant Trial Watch

Is simplification of immunosuppressive medication a way to promote medication adherence of kidney transplant recipients? Findings from a randomized controlled trial.

van Zanten, R., et al.

Transplant International 2021; 34(9): 1703-1711.


Aims
The aim of this study was to examine if converting from tacrolimus plus mycophenolate mofetil (MMF) dual therapy to tacrolimus monotherapy could improve medication adherence of kidney transplant patients.

Interventions
Participants were randomised to either continue tacrolimus and MMF, or to convert to tacrolimus monotherapy.

Participants
79 kidney transplant recipients.

Outcomes
Medication adherence, fear of rejection, satisfaction and number of side effects experienced.

Follow-up
12 months

CET Conclusions
This small single-centre pilot study randomized 79 kidney transplant recipients to either continue tacrolimus and MMF, or to switch to tacrolimus monotherapy, from 6 months post-transplant. The aim was to see if conversion to monotherapy could improve adherence by simplifying the drug regimen. The authors found that adherence was significantly higher in the monotherapy group, with no difference in fear of rejection. The study is well designed, and the results are interesting. There are some limitations – medication adherence was self-reported, which in an unblinded study opens the risk of reporting bias. No clinical outcomes are reported, so it is not clear what the rejection rates were in the two cohorts or indeed whether conversion to monotherapy was actually safe even in the low-risk population recruited.

Jadad score
3

Data analysis
Per protocol analysis

Allocation concealment
Yes

Trial registration
Netherlands Trial Register – NL4672

Funding source
Non-industry funded