Steroid Free Immunosuppression or Calcineurin Inhibitor Minimization After Basiliximab Induction Therapy in Kidney Transplantation: Comparison With a Standard Quadruple Immunosuppressive Regimen

Phase 4 Completed 305 enrolled University Medical Center Groningen Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · collab Leiden University Medical Center · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

A prospective, open, randomized trial, in which the investigators aim to achieve optimal immunosuppression after renal renal transplantation with maximal reduction of side effects, especially of vascular injury, chronic allograft nephropathy, osteoporosis and malignancies. Immunosuppression without steroids and CNI minimization is compared to standard immunosuppression, consisting of tacrolimus OD, mycophenolic acid and corticosteroids.

Timeline

Start: 2011-04
Primary completion: 2015-04
Completion: 2016-04

Outcome

Met primary endpoint

paper Noninferiority was shown for the primary endpoint; PMID 37650722 ↗

Publications

van den Born JC, Meziyerh S, Vart P, Bakker SJL, Berger SP, Florquin S, de Fijter JW, Gomes-Neto AW, Idu MM, Pol RA, Roelen DL, van Sandwijk MS, de Vries DK, de Vries APJ, Bemelman FJ, Sanders JSF. Comparison of 2 Immunosuppression Minimization Strategies in Kidney Transplantation: The ALLEGRO Trial. Transplantation. 2024 Feb 1;108(2):556-566. doi: 10.1097/TP.0000000000004776. Epub 2024 Jan 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prednisolone	Other / unclassified	7.5 mg	—
Subject	Tacrolimus	Small molecule	—	—
Background	mycophenolic acid	Small molecule	540 mg	—