Stumpf, Julian and Thomusch, Oliver and Opgenoorth, Mirian and Wiesener, Michael and Pascher, Andreas and Woitas, Rainer Peter and Suwelack, Barbara and Rentsch, Markus and Witzke, Oliver and Rath, Thomas and Banas, Bernhard and Benck, Urs and Sommerer, Claudia and Kurschat, Christine and Lopau, Kai and Weinmann-Menke, Julia and Jaenigen, Bernd and Trips, Evelyn and Hugo, Christian (2024) Excellent efficacy and beneficial safety during observational 5-year follow-up of rapid steroid withdrawal after renal transplantation (Harmony FU study). NEPHROLOGY DIALYSIS TRANSPLANTATION, 39 (1). pp. 141-150. ISSN 0931-0509, 1460-2385
Full text not available from this repository. (Request a copy)Abstract
Background We previously reported excellent efficacy and improved safety aspects of rapid steroid withdrawal (RSWD) in the randomized controlled 1-year "Harmony" trial with 587 predominantly deceased-donor kidney transplant recipients randomized either to basiliximab or rabbit antithymocyte globulin induction therapy and compared with standard immunosuppressive therapy consisting of basiliximab, low tacrolimus once daily, mycophenolate mofetil and corticosteroids. Methods The 5-year post-trial follow-up (FU) data were obtained in an observational manner at a 3- and a 5-year visit only for those Harmony patients who consented to participate and covered clinical events that occurred from the second year onwards. Results Biopsy-proven acute rejection and death-censored graft loss rates remained low and independent of RSWD. Rapid steroid withdrawal was an independent positive factor for patient survival (adjusted hazard ratio 0.554, 95% confidence interval 0.314-0.976; P = .041). The reduced incidence of post-transplantation diabetes mellitus in RSWD patients during the original 1-year study period was not compensated by later incidences during FU. Incidences of other important outcome parameters such as opportunistic infections, malignancies, cardiovascular morbidity/risk factors, donor-specific antibody formation or kidney function did not differ during FU period. Conclusions With all the limitations of a post-trial FU study, the Harmony FU data confirm excellent efficacy and beneficial safety aspects of RSWD under modern immunosuppressive therapy over the course of 5 years after kidney transplantation in an immunologically low-risk, elderly population of Caucasian kidney transplant recipients.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | DOUBLE-BLIND; LONG-TERM; KIDNEY; RISK; MULTICENTER; THERAPY; THYMOGLOBULIN; RECIPIENTS; AVOIDANCE; INDUCTION; Harmony study; long-term follow-up; mortality; rapid steroid withdrawal; renal transplantation |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Abteilung für Nephrologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 14 May 2024 07:21 |
| Last Modified: | 11 Mar 2025 09:59 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60825 |
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