An interventional study of Additional interventional telemedical management in Kidney Transplant Rejection and Kidney Transplant Failure, sponsored by University of Erlangen-Nürnberg Medical School. Completed at 2 sites in Germany. Open to participants aged 1 Year to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Prevention
The smartNTx trial: Prospective, randomized controlled trial (RCT) to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients (KTR).
STUDY PURPOSE: To demonstrate that additional interventional telemedical management will lead to a higher chance for long-term graft survival, increase adherence, quality of life (QoL), and reduce complications and healthcare costs after kidney transplantation.
This is a 1-year, prospective, randomized, 2-armed, parallel group multicenter trial in 3 German Kidney Transplant Centers (KTCs) to demonstrate that additional and continuous interventional telemedical management will lead to a better composite endpoint of 7 key outcome variables (hospitalizations, length of hospitalization, development of a de-novo donor specific antibody (DSA), medication adherence, tacrolimus intra-patient variability, blood pressure control and renal function after kidney transplantation). All patients will receive the same routine posttransplant aftercare. Patients in the interventional arm will receive a predefined additional telemedical management including regular telemedicine visits and automatic data transfer (e.g. vital signs, well-being, medication plan laboratory data and chat) between the patient at home and KTC through a certified smartphone application (comjoo business solutions GmbH, Berlin, Germany). Furthermore, home nephrologists of patients in the interventional arm are invited to participate in automatic data transfer of key variables (such as vital signs, laboratory data) with KTC. A separate telemedicine team will constantly review the incoming data according to a predefined protocol and eventually contact the patient and/or the home nephrologist in order to start appropriate interventions.
University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the interventional arm will receive a predefined additional telemedical management including regular telemedicine visits and automatic data transfer (e.g. vital signs, well-being, medication plan laboratory data and chat) between the patient at home and KTC through a certified smartphone application.
Combination Product: Additional interventional telemedical management
Patients in the control group will receive routine posttransplant aftercare.
Predefined additional telemedical management including regular telemedicine visits and automatic data transfer (e.g. vital signs, well-being, medication plan laboratory data and chat) between the patient at home and KTC through a certified smartphone application.
Medication adherence
According to BAASIS questionnaire at month 12
Time frame: 12 months
Unplanned hospitalizations
yes/no during study period
Time frame: 12 months
Length of unplanned hospitalization
More/less than 10 nights during study period
Time frame: 12 months
Development of de-novo DSA
yes/no at month 12
Time frame: 12 months
Tacrolimus intra-patient variability
Above/below 30% between month 6 to 12
Time frame: 12 months
Blood pressure control
normal/abnormal 24h-RR profile at month 12
Time frame: 12 months
Renal function
suboptimal renal function (eGFR \< 45 ml/min at month 12
Time frame: 12 months
Reduced graft losses (result evalution)
Documentation of graft losses at all visits - Month 3, 6, 9, 12
Time frame: 12 months
Better prognosis of the iBox score (result evalution)
Documentation of the prognosis of the AI during visit 5, month 12
Time frame: 12 months
Improvement in quality of life (result evalution)
Change in quality of life over 12 months (PROMIS 29 questionnaire) at month 0, 3, 6, 9, 12 (visit 1 to 5).
Time frame: 12 months
Improving disease management (process evalution)
Change in disease management over 12 months (PAM13 questionnaire) at month 0, 3, 6, 9, 12 (visit 1 to 5)
Time frame: 12 months
Acceptance of the new restoration among patients (process evalution)
Survey using established questionnaires and rating and satisfaction with care (own development) at Visit 4, 5 (month 9; 12)
Time frame: 12 months
Acceptance of the new restoration among service providers (process evalution)
Survey using established and newly developed questionnaires, as well as analyzes for usage behavior, including Grade and Assess Predictive tools. Benefit assessment of the data- and AI-supported Decision support (in-house development).
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Erlangen-Nürnberg Medical School