Effect of Steroid Withdrawal on the Appearance of De Novo Donor-Specific HLA Antibodies in Kidney Transplant Recipients: A Prospective, Randomized, Controlled, Parallel Group Study. Preliminary Results
Teresa Vazquez1, Juana Alonso-Titos1, Juan Pablo Gamez1, Pedro Ruiz Esteban1, Abelardo Caballero2, Veronica Lopez1, Eulalia Palma1, Myriam Leon3, Maria Angeles Cobo4, Josep Maria Cruzado5, Joana Sellares6, Armando Torres4, Julia Kanter7, Domingo Hernandez1.
1Nephrology Department, Regional University Hospital of Malaga and University of Malaga, IBIMA, REDinREN (RD16/0009/0006), Malaga, Spain; 2Immunology Department, Regional University Hospital of Malaga and University of Malaga. IBIMA. REDINREN (RD16/0009/0006), Malaga, Spain; 3Pathology Department, Regional University Hospital of Malaga and University of Malaga. IBIMA. REDINREN (RD16/0009/0006), Malaga, Spain; 4Nephrology Department, Hospital Universitario de Canarias, CIBICAN, University of La Laguna, REDinREN (RD16/0009/0031), Tenerife, Spain; 5Nephrology Department, IDIBELL, Hospital de Bellvitge, REDINREN (RD16/0009/0003) Barcelona, Barcelona, Spain; 6Nephrology Department, Hospital Universitari Vall d'Hebron, REDINREN (RD 16/0009/0030), Barcelona, Spain; 7Nephrology Department, Hospital Dr. Peset, Valencia, Spain
Introduction: Steroids represent one of the mainstays of immunosuppression after kidney transplant (KT). Steroid withdrawal reduces metabolic and cardiovascular complications, but whether it increases the risk of acute rejection and the generation of donor-specific anti-HLA antibodies (DSA) is currently undetermined.
Materials and Methods: In a controlled clinical trial (NCT02284464), a total of 176 KT patients with low immunological risk were recruited to randomly receive either conventional triple immunosuppression: steroids, TAC and MMF versus steroid withdrawal at the third post-KT month. We compared the incidence of de novo DSA, determined by Luminex Mixed and Luminex Single Antigen (One Lambda®), and its impact on graft histology in patients with steroid withdrawal at the 3 post-KT month (after a protocol biopsy) versus patients who continue to receive conventional triple immunosuppression.
Results: So far, 68 patients have been randomized (34 per group), with no significant differences in the clinical and demographic characteristics between the groups. The intermediate analysis in those patients who had completed one year of follow-up (n=28) showed no significant differences in the formation of DSA (0% vs. 0%), nor was there rejection in those patients in whom prednisone was withdrawn after randomization. Patients with triple therapy showed a trend toward better renal function compared to those without steroids at the first post-KT year (1.29±0.25 vs. 1.56±0.42 mg/dL, P=0.088). HbA1c levels were similar between both group at the first post-KT year (5.79±0.59 vs. 5.68±0.81%, P=0.734).
Conclusion:The preliminary results show that steroid withdrawal at the 3 month post-KT seems safe when assessing the appearance of rejection and formation of DSA compared to the patients who continued to receive conventional triple immunosuppression.
Spanish Ministry of Economy and Competitiveness (MINECO) (grant ICI14/00016) from the Instituto de Salud Carlos III co-funded by the Fondo Europeo de Desarrollo Regional–FEDER, RETICS (REDINREN RD12/0021/0015, RD16/0009/0006, RD16/0009/0003, RD16/0009/0030, RD16/0009/0031).
