Comparison of 2 Immunosuppression Minimization Strategies in Kidney Transplantation: The ALLEGRO Trial
A Dutch randomized trial found that either withdrawing steroids early or lowering tacrolimus from 6 months gave kidney function at 2 years that was non-inferior to standard triple therapy, though early steroid withdrawal led to more treated rejection but less diabetes.
Study design
ALLEGRO was an investigator-driven, multicenter, open-label non-inferiority trial in de novo kidney transplant recipients. Patients received basiliximab, corticosteroids, tacrolimus, and mycophenolic acid, then were randomized to standard immunosuppression, early steroid withdrawal from day 3, or reduced tacrolimus exposure from 6 months. The primary endpoint was eGFR at 24 months; 295 participants were analysed by intention to treat.
Key findings
Non-inferiority was met for both minimization strategies: 24-month eGFR was 45.3 mL/min/1.73 m2 with early steroid withdrawal, 49.0 with standard immunosuppression, and 44.7 with tacrolimus minimization. Patients in the early steroid withdrawal group were significantly more often treated for rejection (P=0.04) but had fewer cases of post-transplant diabetes and lower total cholesterol at 24 months.
Clinical implications
Tacrolimus minimization can be considered in recipients without elevated immunological risk, and early steroid withdrawal trades a higher rejection risk for metabolic advantages. The trial supports individualized minimization but underscores weighing rejection risk against metabolic benefit before withdrawing steroids.
Category
Transplant
Source
Transplantation
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