Date: Sunday, June 2, 2019
Session Time: 4:30pm-6:00pm
Presentation Time: 5:30pm-5:42pm
Location: Veterans Auditorium
*Purpose: Comparison of two immunosuppressive protocols, steroid-free with antithymocyte globulin (ATG) induction, and steroid containing with basiliximab induction, regarding the incidence of PTDM, one year after renal transplantation.
*Methods: The study is an open-label, multicenter, randomized controlled trial where eligible patients were assigned prior to renal transplantation, to receive either ATG, low-dose tacrolimus and mycophenolate mofetil (MMF) (arm-A), or basiliximab, low-dose tacrolimus, MMF, and prednisolone (arm-B). Adult patients at low immunological risk, without pre-transplant diabetes mellitus, receiving single organ, ABO compatible, kidney transplant were included. The primary objective was to determine the cumulative incidence of PTDM at one year, assessed according to the American Diabetes Association recommendations. The secondary objective was the composite measure of freedom from biopsy-proven active rejection (BPAR), graft survival and patient survival.
*Results: A total of 222 patients were included in the study and randomized to arm-A (N=113) and arm-B (N=109). The cumulative incidence of PTDM one year after renal transplantation was overall low, 13.3% in study arm-A and as compared to 18.3% in control arm-B (p=0.4). The rate of BPAR (arm-A 19% vs. arm-B 15%, p=0.5), graft and patient survival was similar in both groups. Higher proportion of patients in arm-B needed >=3 antihypertensive drugs (arm-B 33% vs. arm-A 20%, p=0.03), and lipid-lowering medication (arm-B 33% vs. arm-A 20%, p=0.05).
*Conclusions: Steroid-free immunosuppression with ATG induction and low-dose tacrolimus did not reduce the incidence of PTDM within the first year after renal transplantation, but offered easily manageable hypertension and hyperlipidemia, as well as a good safety profile.
To cite this abstract in AMA style:Ekberg J, Baid-Agrawal S, Jespersen B, Källén R, Rafael E, Skov K, Lindnér P. Impact of Steroid-Free Protocol on Incidence of Posttransplantation Diabetes Mellitus: A Prospective, Randomized, Multicenter, Open-Label, Controlled Trial in Renal Transplant Recipients [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/impact-of-steroid-free-protocol-on-incidence-of-posttransplantation-diabetes-mellitus-a-prospective-randomized-multicenter-open-label-controlled-trial-in-renal-transplant-recipients/. Accessed October 22, 2020.
« Back to 2019 American Transplant Congress