The smartNTx Trial: A Prospective, Randomized Controlled Trial (RCT) to Investigate Additional Interventional Telemedical Management Versus Standard Aftercare in Kidney Transplant Recipients (KTR)

NCT ID: NCT05897047

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2026-08-30

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.

Conditions

Kidney Transplant Rejection; Kidney Transplant Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group "Additional telemedical management"

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.

Group Type: EXPERIMENTAL

Additional interventional telemedical management

Intervention Type: COMBINATION_PRODUCT

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.

Control group "Routine posttransplant aftercare"

Patients in the control group will receive routine posttransplant aftercare.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Additional interventional telemedical management

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.

Intervention Type: COMBINATION_PRODUCT

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).

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

University Hospital, Essen

OTHER

Sponsor Role: collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mario Schiffer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Uniklinikum Erlangen

Locations

Charité Universitätsmedizin Berlin

Berlin, Bavaria, Germany

University Hospital Essen

Essen, , Germany

Countries

Germany

References

Schiffer M, Pape L, Wolff JK, Gertges R, Visconti V, Reichert K, Pfau A, Dieterle A, Sauerstein K, Kribben A, Boss K, Karaterzi S, Nensa F, Winneckens P, Cypko M, Duettmann W, Zukunft B, Schrezenmeier E, Naik MG, Halleck F, Roller R, Moller S, Amft O, Budde K. The SmartNTx-study: a prospective, randomized controlled trial to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients. Front Nephrol. 2025 Jun 19;5:1591962. doi: 10.3389/fneph.2025.1591962. eCollection 2025.

Reference Type: DERIVED

PMID: 40612527 (View on PubMed)

Other Identifiers

0673

Identifier Type: OTHER

Identifier Source: secondary_id

01NVF21116

Identifier Type: -

Identifier Source: org_study_id