ArticleNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2023
Excellent efficacy and beneficial safety during observational 5-year follow-up of rapid steroid withdrawal after renal transplantation (Harmony FU study).
Article in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00724022 (Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- Steroid avoidance or withdrawal for kidney transplant recipients.The Cochrane database of systematic reviews · 2026Pooled it
- Steroid Avoidance in Kidney Transplantation: From Vision to Velocity.Kidney international reports · 2025Article
- Steroid Avoidance With Low-Dose Tacrolimus is Safe and Effective in the Long-Term for Kidney Transplant Recipients.Kidney international reports · 2025Article
- Chronic Allograft Nephropathy-A Narrative Review of Its Pathogenesis, Diagnosis, and Evolving Management Strategies.Biomedicines · 2025Review
- Early steroid withdrawal and kidney transplant outcomes in first-transplant and retransplant recipients.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025Article
- Clinical and Histopathological Determinants for Kidney Allograft Survival in the Eurotransplant Senior Program (ESP) at the Time of Allocation.Transplant international : official journal of the European Society for Organ Transplantation · 2025Article
- Kidney Transplant Outcomes With Non-Depleting Antibody Induction Therapy in Human Leucocyte Antigen Sensitised Recipients.Transplant international : official journal of the European Society for Organ Transplantation · 2025Article
- Infection Risk in Older Kidney Transplant Recipients: An Analysis in the Era of Expanded Age Limits.Transplant international : official journal of the European Society for Organ Transplantation · 2025Article
- Current practices in prevention, screening, and treatment of diabetes in kidney transplant recipients: European survey highlights from the ERA DESCARTES Working Group.Clinical kidney journal · 2025Article
- Precision in Immune Management: Balancing Steroid Exposure, Rejection Risk, and Infectious Outcomes in Adult Kidney Transplant Recipients.Journal of personalized medicine · 2024Article
- Article
Corrections and comments
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Authors and funding
19 authors at 12 institutions in 1 country.
Funding
Abstract
backgroundWe 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.
methodsThe 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.
resultsBiopsy-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.
conclusionsWith 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. Trial registration: Clinical trial registration number: Investigator Initiated Trial (NCT00724022, FU study DRKS00005786).
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