The smartNTx Trial:Telemedical Management Versus Standard Aftercare in Kidney Transplant Recipients (KTR)

NCT05897047 | Active Not Recruiting

• 2 other identifiers: 01NVF211160673
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Transplant Rejection; Kidney Transplant Failure

Keywords

Aftercare; Telemedical Management

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• Reduced graft losses (result evalution)

  12 months

• Better prognosis of the iBox score (result evalution)

  12 months

• Improvement in quality of life (result evalution)

  12 months

• Improving disease management (process evalution)

  12 months

• Acceptance of the new restoration among patients (process evalution)

  12 months

Study Arms (2)

Intervention group "Additional telemedical management"

EXPERIMENTAL

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

Control group "Routine posttransplant aftercare"

NO INTERVENTION

Patients in the control group will receive routine posttransplant aftercare.

Interventions

Additional interventional telemedical management 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.

Intervention group "Additional telemedical management"

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[82\]

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Charite University, Berlin, Germany: collaborator
• University Hospital, Essen: collaborator

Study Sites (2)

Charité Universitätsmedizin Berlin

Berlin, Bavaria, 10117, Germany

Location

University Hospital Essen

Essen, Germany

Location

Related Publications (1)

• 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.

  PMID: 40612527 BACKGROUND

Study Officials

• Mario Schiffer, Prof. Dr.

  Uniklinikum Erlangen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, two-armed randomized controlled trial (RCT)

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 9, 2023
• Study Start: May 15, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)