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Kidney Transplant RejectionsmartNTxNCT05897047

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

A study testing Additional interventional telemedical management in people with Kidney Transplant Rejection and Kidney Transplant Failure, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The smartNTx trial: Prospective, randomized controlled trial (RCT) to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients (KTR). Read more about this study

Who is it for?
Ages 1 year to 99 years
What is being tested?
Additional interventional telemedical management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
391 participants
Where
2 sitesGermany
Study dates
15 May 2023to 30 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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]

Who cannot join

  • 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)
Show all 11Show fewer
  • 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).

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Charité Universitätsmedizin Berlin

    Berlin, Bavaria, 10117

  • University Hospital Essen

    Essen

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Additional interventional telemedical management
Keywords
Aftercare, Telemedical Management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Additional interventional telemedical managementCombination 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.

Study groups in NCT05897047
Study groupRoleWhat they receive
Intervention group "Additional telemedical management"ExperimentalPatients 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.
Receives: Combination Product: Additional interventional telemedical management
Control group "Routine posttransplant aftercare"No interventionPatients in the control group will receive routine posttransplant aftercare.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medication adherence

    According to BAASIS questionnaire at month 12

    Measured: 12 months

  2. Unplanned hospitalizations

    yes/no during study period

    Measured: 12 months

  3. Length of unplanned hospitalization

    More/less than 10 nights during study period

    Measured: 12 months

  4. Development of de-novo DSA

    yes/no at month 12

    Measured: 12 months

  5. Tacrolimus intra-patient variability

    Above/below 30% between month 6 to 12

    Measured: 12 months

  6. Blood pressure control

    normal/abnormal 24h-RR profile at month 12

    Measured: 12 months

  7. Renal function

    suboptimal renal function (eGFR < 45 ml/min at month 12

    Measured: 12 months

Secondary outcomes (6)

  1. Reduced graft losses (result evalution)

    Documentation of graft losses at all visits - Month 3, 6, 9, 12

    Measured: 12 months

  2. Better prognosis of the iBox score (result evalution)

    Documentation of the prognosis of the AI during visit 5, month 12

    Measured: 12 months

  3. 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).

    Measured: 12 months

  4. 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)

    Measured: 12 months

  5. 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)

    Measured: 12 months

  6. 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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2023
  2. Study start15 May 2023
  3. Primary completion30 Apr 2026
  4. Study completion30 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, two-armed randomized controlled trial (RCT)
Masking
None (open label)
Enrolment
391 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05897047
Sponsor's protocol ID
01NVF21116
Other IDs
0673
Acronym
smartNTx
Status last verified
Aug 2026
First submitted
15 May 2023
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40612527

Questions about this trial

What is this clinical trial studying?

A study testing Additional interventional telemedical management in people with Kidney Transplant Rejection and Kidney Transplant Failure, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication adherence (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05897047, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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