Prospective, Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Randomized Controlled Trial to Investigate Additional Interventional Telemedical Management Versus Standard Aftercare in Kidney Transplant Recipients (smartNTx)

Conditions
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Kidney Transplant Rejection

Intervention / Treatment
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* Combination Product: Additional interventional telemedical management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kidney transplantation within last 12 months Treatment with tacrolimus Routine aftercare planned at KTC Ability to use a smartphone or tablet or with help of someone close by For children < 12 years parents have to take over the use of the smartphone Patients who are willing and able to participate in the study and from whom written informed consent has been obtained prior to study participation or pediatric patients with parenteral consent Ability to communicate in German or English Adequate and stable renal function (eGFR > 30 ml/min, Proteinuria < 1g/g creatinine) eGFR will be determined according to CKD-EPI for adults [81] or Schwartz formula for children [82] Exclusion Criteria: Patient with mental dysfunction or inability to comply with the study protocol or pediatric patients whose parents cannot comply with the study protocol Any significant diseases or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination findings that would in the opinion of the investigator preclude the patient from participating in the study History of alcohol or drug abuse with less than 6 months of sobriety Participation in any other interventional clinical trial less than 1 month before participation in this study Patients who have been institutionalized by official or court order Patients with a combined kidney transplant or multi-organ recipients (other solid organ (e.g. pancreas) or bone marrow) Presence of DSA with MFI > 1000 at time of transplantation Recurrence of underlying kidney disease (e.g. focal segmental glomerulosclerosis (FSGS) or atypical hemolytic uremic syndrome (aHUS) Patient with active malignancy post-transplant with the exception of local, non-invasive, fully excised, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ Patients with clinically symptomatic congestive heart failure (CHF) or symptomatic coronary artery disease Patients with documented (either by serology and/or nuclear acid testing (NAT) clinically active infections (e.g. with a known hepatitis B (HBV), hepatitis C (HCV), HIV, CMV or BK virus infection).

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, two-armed randomized controlled trial (RCT)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group Additional telemedical management<br>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<br>* 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.<br>|
| No Intervention: Control group Routine posttransplant aftercare<br>Patients in the control group will receive routine posttransplant aftercare. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | According to BAASIS questionnaire at month 12 | 12 months | 
| Unplanned hospitalizations | yes/no during study period | 12 months | 
| Length of unplanned hospitalization | More/less than 10 nights during study period | 12 months | 
| Development of de-novo DSA | yes/no at month 12 | 12 months | 
| Tacrolimus intra-patient variability | Above/below 30% between month 6 to 12 | 12 months | 
| Blood pressure control | normal/abnormal 24h-RR profile at month 12 | 12 months | 
| Renal function | suboptimal renal function (eGFR < 45 ml/min at month 12 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced graft losses (result evalution) | Documentation of graft losses at all visits - Month 3, 6, 9, 12 | 12 months | 
| Better prognosis of the iBox score (result evalution) | Documentation of the prognosis of the AI during visit 5, month 12 | 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). | 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) | 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) | 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). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aftercare, Telemedical Management