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Impact on Graft Histology of Steroid Withdrawal versus Standard Immunosuppression: Randomized, Parallel Group, Controlled Clinical Trial in Low Immunological Risk Kidney Transplant Patients

E. Gutiérrez Vílchez1, T. Vázquez1, V. López1, M. León2, E. Sola1, J. Sellares3, M. Cobo4, J. Cruzado5, A. Torío6, J. Kanter7, P. Ruiz-Esteban1, D. Hernández1

1Nephrology Service, Regional University Hospital, University of Malaga, IBIMA, REDinREN (RD16/0009/0006), Málaga, Spain, 2Pathology Department, Regional University Hospital, University of Malaga, IBIMA, REDinREN (RD16/0009/0006), Málaga, Spain, 3Nephrology Department, Hospital Vall de Hebron, Barcelona, Spain, 4Cardiology Department, Hospital Marqués de Valdecilla, Santander, Spain, 5Nephrology Department, Hospital de Bellvitge, Barcelona, Spain, 6Immunology, Regional University Hospital, University of Malaga, IBIMA, REDinREN (RD16/0009/0006), Málaga, Spain, 7Nephrology Department, Hospital Universitario Dr. Peset, Valencia, Spain

Meeting: 2020 American Transplant Congress

Abstract number: 328

Keywords: Graft survival, Hypertension, Immunosuppression, Inflammation

Session Information

Session Name: Immunosuppressive Drug Minimization

Session Type: Oral Abstract Session

Date: Saturday, May 30, 2020

Session Time: 3:15pm-4:45pm

 Presentation Time: 3:27pm-3:39pm

Location: Virtual

*Purpose: Steroid withdrawal can improve cardiovascular risk but little is known about its impact on graft histology and donor-specific antibodies.

*Methods: 105 patients with a first kidney transplant, low immunological risk and stable renal function were randomized at third month postransplant to receive triple therapy (A: steroids+Tac+MMF, n=52) or therapy without steroids (B: Tac+MMF, n=53) after a graft biopsy that showed subclinical inflammatory lesions (A, n=14 vs. B, n=16). A second biopsy at 24 months showed a similar number of inflammatory lesions in both groups.

*Results: Patients with borderline lesions at third month had more chronicity lesions (ci+ct+cv+cg 1.6±1.3 vs. 0.9±1.02, p=0.008) and worse renal function (46±12 vs 57±21 ml/min; p=0.008) than those without these lesions. A significant correlation between the severity of chronic lesions (ci+ct+cv+cg) and interstitial inflammation (r=0.247; p=0.005) was noted. All patients in both groups with normal biopsies at the third month showed increase in the inflammatory (t, i) and chronicity score (ci, ct), with a significant correlation between the degree of chronicity (ci+ct+cv+cg) and interstitial inflammation, at 24 months post-transplant (r=0.328; p=0.020). Patients with borderline lesions at the third month post-transplant in Group B showed a more pronounced increase in chronic lesions at 24 months (ci+ct+cv+cg 1.5±1.2 vs. 3.25±1.03, p=0.009) than those of Group A (1.87±1.5 vs. 2.4±1.1, p=0.470), as well as worse renal function (59.8±17 vs. 46±12, p=0.026). No patient developed DSA at 24 months post-transplant using a MFI>500. Finally, a significant decrease in hemoglobin A1c (5.7±0.6 vs. 6.3±1.2%, p=0.013) and systolic blood pressure (125±15 vs. 133±16 mmHg; p=0.055) was noted in the Group B patients versus the Group A patients.

*Conclusions: Steroid withdrawal in patients with a low immunological risk improves the cardiovascular profile with no risk of producing DSA, at least over the medium term, though the price to pay may be more chronic graft lesions and worse renal function, particularly in patients with early borderline lesions (third month post-transplant).

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To cite this abstract in AMA style:

Vílchez EGutiérrez, Vázquez T, López V, León M, Sola E, Sellares J, Cobo M, Cruzado J, Torío A, Kanter J, Ruiz-Esteban P, Hernández D. Impact on Graft Histology of Steroid Withdrawal versus Standard Immunosuppression: Randomized, Parallel Group, Controlled Clinical Trial in Low Immunological Risk Kidney Transplant Patients [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/impact-on-graft-histology-of-steroid-withdrawal-versus-standard-immunosuppression-randomized-parallel-group-controlled-clinical-trial-in-low-immunological-risk-kidney-transplant-patients/. Accessed May 11, 2025.

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