Excellent efficacy and beneficial safety during observational 5-year follow-up of rapid steroid withdrawal after renal transplantation (Harmony FU study)

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung


  • Julian Stumpf - , Medizinische Klinik und Poliklinik 3, Universitätsklinikum Carl Gustav Carus Dresden (Autor:in)
  • Oliver Thomusch - , Albert-Ludwigs-Universität Freiburg (Autor:in)
  • Mirian Opgenoorth - , Staatliche Berufsfachschulen am Universitätsklinikum Erlangen (Autor:in)
  • Michael Wiesener - , Staatliche Berufsfachschulen am Universitätsklinikum Erlangen (Autor:in)
  • Andreas Pascher - , Universitätsklinikum Münster (Autor:in)
  • Rainer Peter Woitas - , Universitätsklinikum Bonn (Autor:in)
  • Barbara Suwelack - , Universitätsklinikum Münster (Autor:in)
  • Markus Rentsch - , Klinikum der Ludwig-Maximilians-Universität (LMU) München (Autor:in)
  • Oliver Witzke - , Universitätsklinikum Essen (Autor:in)
  • Thomas Rath - , Westpfalz-Klinikum GmbH (Autor:in)
  • Bernhard Banas - , Universitätsklinikum Regensburg (Autor:in)
  • Urs Benck - , SRH University Heidelberg (Autor:in)
  • Claudia Sommerer - , Nationales Zentrum für Tumorerkrankungen (NCT) Heidelberg (Autor:in)
  • Christine Kurschat - , Universitätsklinikum Köln (Autor:in)
  • Kai Lopau - , Hospital de Basurto (Autor:in)
  • Julia Weinmann-Menke - , Universitätsmedizin Mainz (Autor:in)
  • Bernd Jaenigen - , Albert-Ludwigs-Universität Freiburg (Autor:in)
  • Evelyn Trips - , Koordinierungszentrum für Klinische Studien Dresden (KKS-DD) (Autor:in)
  • Christian Hugo - , Medizinische Klinik und Poliklinik 3, Universitätsklinikum Carl Gustav Carus Dresden (Autor:in)


BACKGROUND: We previously reported excellent efficacy and improved safety aspects of rapid steroid withdrawal in the randomized controlled one year 'Harmony' trial with 587 predominantly deceased-donor kidney transplant recipients randomized either to basiliximab or rabbit antithymocyte globulin induction therapy and compared to standard immunosuppressive therapy consisting of basiliximab, low tacrolimus once daily, mycophenolate mofetil, and corticosteroids.

METHODS: The five-year post-trial follow-up data were obtained in an observational manner at a three and a five-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 rapid steroid withdrawal. Rapid steroid withdrawal was an independent positive factor for patient survival (adjusted hazard ratio 0.554, 95% confidence interval 0.314 to 0.976; P = 0.041).The reduced incidence of post-transplantation diabetes mellitus in rapid steroid withdrawal patients during the original one-year study period was not compensated by later incidences during follow-up. 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 follow-up period.

CONCLUSIONS: With all limitations of a post-trial follow up study, the Harmony follow-up data confirms excellent efficacy and beneficial safety aspects of rapid steroid withdrawal 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.(Clinical trial registration number: Investigator Initiated Trial (NCT00724022, follow-up study DRKS00005786).


Seiten (von - bis)141-150
FachzeitschriftNephrology Dialysis Transplantation
Frühes Online-Datum30 Juni 2023
PublikationsstatusVeröffentlicht - 1 Jan. 2024

Externe IDs

ORCID /0000-0002-6530-5855/work/146646279
Scopus 85180401296
unpaywall 10.1093/ndt/gfad130
Mendeley bb61df20-1609-338c-9c81-9d948193b13f


Ziele für nachhaltige Entwicklung


  • Graft Rejection/drug therapy, Kidney Transplantation/adverse effects, Follow-Up Studies, Immunosuppressive Agents/adverse effects, Basiliximab, Humans, Mycophenolic Acid/therapeutic use, Graft Survival, Aged, Antibodies, Monoclonal, Tacrolimus/adverse effects, Steroids