Comparison of 2 Immunosuppression Minimization Strategies in Kidney Transplantation: The ALLEGRO Trial.van den Born, J. C., et al.
Transplantation 2023 [record in progress].
The aim of this trial was to compare standard immunosuppression with two immunosuppression minimisation strategies in de novo kidney transplant recipients.
Participants were randomised to one of three groups: the early steroid withdrawal arm, the standard-dose tacrolimus arm, and the tacrolimus minimisation arm.
295 de novo kidney transplant recipients.
The primary outcome was kidney function at 24 months posttransplantation. The secondary outcomes were patient survival, treated rejection, kidney failure, discontinuation of study medication for more than 6 weeks, and treatment failure.
This multicentre trial from the Netherlands randomised de novo renal transplant recipients to one of three immunosuppression strategies – standard care, early steroid withdrawal or tacrolimus minimisation at 6 months. The study was designed to demonstrate non-inferiority in renal function at 24 months, and met the primary endpoint, with no difference seen between the three groups. There was a higher incidence of acute rejection in the early steroid withdrawal group, but no increase in DSA formation. In general, study design is good although unblinded, with centralised randomisation and intent-to-treat analysis. Withdrawal rate was around 25% in each arm at 24 months. Inclusion criteria are fairly broad for an immunosuppression minimisation study, allowing recipients up to 80 years of age, PRA up to 75% and first or second transplants. One notable exclusion criteria was for type 1 diabetic recipients; the authors do not provide a rationale for this.
ClinicalTrials.gov - NCT01560572