Results of a multicenter, randomized trial examining a new transition model for post-kidney transplant adolescents
Abstract Allograft loss after pediatric kidney transplantation (KTx) is highest in adolescents and young adults. Non-adherence and Health Care Transition (HCT) are important factors, but others also contribute. In the TransNephro study patients were randomized 1:1. The intervention group was include...
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2025-04-01
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| Online Access: | https://doi.org/10.1038/s41598-025-95845-7 |
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| author | Martin Kreuzer Jenny Prüfe Marie-Luise Dierks Silvia Müther Dirk Bethe Anja Büscher Krisztina Heindl-Rusai Sabine Hollenbach Bernd Hoppe Ulrike John-Kroegel Nele Kirsten Kanzelmeyer Günter Klaus Birgitta Kranz Jun Oh Martin Pohl Susanne Rieger Bettina Ruckenbrodt Katja Sauerstein Hagen Staude Christina Taylan Julia Thumfart Marcus Weitz Rieke Ringlstetter Anika Großhennig Lars Pape |
| author_facet | Martin Kreuzer Jenny Prüfe Marie-Luise Dierks Silvia Müther Dirk Bethe Anja Büscher Krisztina Heindl-Rusai Sabine Hollenbach Bernd Hoppe Ulrike John-Kroegel Nele Kirsten Kanzelmeyer Günter Klaus Birgitta Kranz Jun Oh Martin Pohl Susanne Rieger Bettina Ruckenbrodt Katja Sauerstein Hagen Staude Christina Taylan Julia Thumfart Marcus Weitz Rieke Ringlstetter Anika Großhennig Lars Pape |
| author_sort | Martin Kreuzer |
| collection | DOAJ |
| description | Abstract Allograft loss after pediatric kidney transplantation (KTx) is highest in adolescents and young adults. Non-adherence and Health Care Transition (HCT) are important factors, but others also contribute. In the TransNephro study patients were randomized 1:1. The intervention group was included in the Berlin Transition Program (BTP) and incorporated a central case manager, a communication app, and joined transition rounds for one year before and one year after transfer. Primary endpoint was the coefficient of variation (CoV) of the trough level of the calcineurin inhibitor as a surrogate marker for medication adherence associated with graft loss. Least square (LS) mean differences and corresponding 95% confidence intervals (CIs) were estimated using an analysis of covariance (ANCOVA) model. We assessed 220 patients for eligibility. 49 patients were randomized to the intervention group and 53 to the control group. We analyzed 84 patients in the modified intention-to-treat analysis (38 intervention, 46 controls) and 60 in the per protocol analysis (25 intervention, 35 controls). We found no difference in CoV. We saw low numbers of graft-related events and observed no differences with respect to quality of life. BTP did not improve adherence and other outcome parameters. Non-adherent patients may have decided not to participate, whilst adherence of participants was already good at study start. It is therefore achallenge to design future multicenter trials on HCT that include multiple interventions. Trial registration: ISRCTN22988897, 24/04/2014, https://doi.org/10.1186/ISRCTN22988897 . |
| format | Article |
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| language | English |
| publishDate | 2025-04-01 |
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| spelling | doaj-art-25702d64ae0644f99466a0401c1976df2025-08-20T03:07:40ZengNature PortfolioScientific Reports2045-23222025-04-0115111010.1038/s41598-025-95845-7Results of a multicenter, randomized trial examining a new transition model for post-kidney transplant adolescentsMartin Kreuzer0Jenny Prüfe1Marie-Luise Dierks2Silvia Müther3Dirk Bethe4Anja Büscher5Krisztina Heindl-Rusai6Sabine Hollenbach7Bernd Hoppe8Ulrike John-Kroegel9Nele Kirsten Kanzelmeyer10Günter Klaus11Birgitta Kranz12Jun Oh13Martin Pohl14Susanne Rieger15Bettina Ruckenbrodt16Katja Sauerstein17Hagen Staude18Christina Taylan19Julia Thumfart20Marcus Weitz21Rieke Ringlstetter22Anika Großhennig23Lars Pape24Clinic of Pediatrics II, Essen University HospitalClinic of Pediatrics II, Essen University HospitalDepartment of Epidemiology, Social Medicine and Health System Research, Hannover Medical SchoolBerliner TransitionsProgramm (BTP), DRK-Kliniken Berlin WestendDivision of Pediatric Nephrology, Center for Child and Adolescent Medicine, Heidelberg University HospitalClinic of Pediatrics II, Essen University HospitalUniversity Children’s HospitalKfH Center of Pediatric Nephrology, St. Georg HospitalBonn Center of Pediatric NephrologyPediatric Nephrology, Universitätsklinikum JenaDepartment of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical SchoolKfH Center of Pediatric Nephrology, University Hospital of MarburgUniversity Children’s Hospital MünsterUniversity Children’s Hospital EppendorfDepartment of General Pediatrics, Adolescent Medicine and Neonatology, Freiburg University HospitalDivision of Pediatric Nephrology, Center for Child and Adolescent Medicine, Heidelberg University HospitalChildren‘s Hospital, Olgahospital Klinikum StuttgartChildren’s Hospital, University of ErlangenUniversity Children’s HospitalPediatric Nephrology, University Hospital of CologneDepartment of Pediatric Nephrology, Campus Charité Virchow KlinikumUniversity Children’s Hospital TübingenInstitute of Biostatistics, Hannover Medical SchoolInstitute of Biostatistics, Hannover Medical SchoolClinic of Pediatrics II, Essen University HospitalAbstract Allograft loss after pediatric kidney transplantation (KTx) is highest in adolescents and young adults. Non-adherence and Health Care Transition (HCT) are important factors, but others also contribute. In the TransNephro study patients were randomized 1:1. The intervention group was included in the Berlin Transition Program (BTP) and incorporated a central case manager, a communication app, and joined transition rounds for one year before and one year after transfer. Primary endpoint was the coefficient of variation (CoV) of the trough level of the calcineurin inhibitor as a surrogate marker for medication adherence associated with graft loss. Least square (LS) mean differences and corresponding 95% confidence intervals (CIs) were estimated using an analysis of covariance (ANCOVA) model. We assessed 220 patients for eligibility. 49 patients were randomized to the intervention group and 53 to the control group. We analyzed 84 patients in the modified intention-to-treat analysis (38 intervention, 46 controls) and 60 in the per protocol analysis (25 intervention, 35 controls). We found no difference in CoV. We saw low numbers of graft-related events and observed no differences with respect to quality of life. BTP did not improve adherence and other outcome parameters. Non-adherent patients may have decided not to participate, whilst adherence of participants was already good at study start. It is therefore achallenge to design future multicenter trials on HCT that include multiple interventions. Trial registration: ISRCTN22988897, 24/04/2014, https://doi.org/10.1186/ISRCTN22988897 .https://doi.org/10.1038/s41598-025-95845-7 |
| spellingShingle | Martin Kreuzer Jenny Prüfe Marie-Luise Dierks Silvia Müther Dirk Bethe Anja Büscher Krisztina Heindl-Rusai Sabine Hollenbach Bernd Hoppe Ulrike John-Kroegel Nele Kirsten Kanzelmeyer Günter Klaus Birgitta Kranz Jun Oh Martin Pohl Susanne Rieger Bettina Ruckenbrodt Katja Sauerstein Hagen Staude Christina Taylan Julia Thumfart Marcus Weitz Rieke Ringlstetter Anika Großhennig Lars Pape Results of a multicenter, randomized trial examining a new transition model for post-kidney transplant adolescents Scientific Reports |
| title | Results of a multicenter, randomized trial examining a new transition model for post-kidney transplant adolescents |
| title_full | Results of a multicenter, randomized trial examining a new transition model for post-kidney transplant adolescents |
| title_fullStr | Results of a multicenter, randomized trial examining a new transition model for post-kidney transplant adolescents |
| title_full_unstemmed | Results of a multicenter, randomized trial examining a new transition model for post-kidney transplant adolescents |
| title_short | Results of a multicenter, randomized trial examining a new transition model for post-kidney transplant adolescents |
| title_sort | results of a multicenter randomized trial examining a new transition model for post kidney transplant adolescents |
| url | https://doi.org/10.1038/s41598-025-95845-7 |
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