Clinical trial NCT05897047: The smartNTx Trial: A Prospective, Randomized Controlled Trial (RCT) to Investigate Additional Interventional Telemedical Management Versus Standard Aftercare in Kidney Transplant Recipients (KTR)
Official title: Prospective, Randomized Controlled Trial to Investigate Additional Interventional Telemedical Management Versus Standard Aftercare in Kidney Transplant Recipients (smartNTx)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Transplant Rejection
Kidney Transplant Failure
Keywords: Aftercare
Telemedical Management
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: University Hospital, Essen
First posted: 2023-06-09
Enrollment: 384
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, two-armed randomized controlled trial (RCT)
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Medication adherence
timeFrame: 12 months
measure: Unplanned hospitalizations
timeFrame: 12 months
measure: Length of unplanned hospitalization
timeFrame: 12 months
measure: Development of de-novo DSA
timeFrame: 12 months
measure: Tacrolimus intra-patient variability
timeFrame: 12 months
measure: Blood pressure control
timeFrame: 12 months
measure: Renal function
timeFrame: 12 months
Secondary outcomes:
measure: Reduced graft losses (result evalution)
timeFrame: 12 months
measure: Better prognosis of the iBox score (result evalution)
timeFrame: 12 months
measure: Improvement in quality of life (result evalution)
timeFrame: 12 months
measure: Improving disease management (process evalution)
timeFrame: 12 months
measure: Acceptance of the new restoration among patients (process evalution)
timeFrame: 12 months
measure: Acceptance of the new restoration among service providers (process evalution)
timeFrame: 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
state: Bavaria
city: Essen
country: Germany
facility: University Hospital Essen
Study officials:
affiliation: Uniklinikum Erlangen
name: Mario Schiffer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: