A Randomized Controlled Trial of Envarsus Versus Immediate Release Tacrolimus in Kidney Transplant Recipients With Delayed Graft Function.
Parajuli, S., et al.Transplantation Proceedings 2023 [record in progress].
Aims
The aim of this study was to compare the effect of immediate-release versus extended-release tacrolimus (Envarsus) among kidney transplant recipients with delayed graft function (DGF).
Interventions
Participants were randomly assigned to either continue on immediate-release tacrolimus or convert to Envarsus.
Participants
100 kidney transplant recipients.
Outcomes
The main outcomes of interest included duration of DGF, requirement for calcineurin inhibitor (CNI) dose adjustment and number of dialysis treatments.
Follow-up
3 months posttransplantation
CET Conclusions
This single-centre RCT randomised kidney transplant recipients with delayed graft function to continue immediate-release tacrolimus or switch to a modified release (MR) formulation. 100 recipients were enrolled in the study, and no difference was found in the duration of DGF and number of dialysis treatments required between the two arms. Patients on the MR formulation required fewer dose adjustments. There are, as ever, issues with studies using DGF as an endpoint or inclusion criteria. Patients had to be enrolled as soon as possible after DGF was established, but up to 72 hours. Thus, in some cases late enrolment may limit the ability of the change in formulation to have a clinical effect. As the DGF definition used was requirement for dialysis post-operatively, outcomes are difficult to interpret for patients undergoing pre-emptive transplantation (although very few patients were pre-emptive in the current study). The study end-point is also very subjective, particularly for a non-blinded study, defined as the clinician’s decision to discharge the patient from DGF clinic. No sample size calculation is presented, raising the possibility of a type II error if the study is underpowered. Overall, this study provides no evidence of improve clinical outcome to support a switch to MR tacrolimus in this patient population.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT03864926