The smartNTx Trial:Telemedical Management Versus Standard Aftercare in Kidney Transplant Recipien… (NCT05897047) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The smartNTx Trial:Telemedical Management Versus Standard Aftercare in Kidney Transplant Recipients (KTR)
Germany384 participantsStarted 2023-05-15
Plain-language 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.
Who can participate
Age range
1 Year – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Medication adherence
Timeframe: 12 months
2
Unplanned hospitalizations
Timeframe: 12 months
3
Length of unplanned hospitalization
Timeframe: 12 months
4
Development of de-novo DSA
Timeframe: 12 months
5
Tacrolimus intra-patient variability
Timeframe: 12 months
6
Blood pressure control
Timeframe: 12 months
7
Renal function
Timeframe: 12 months
Trial details
NCT IDNCT05897047
SponsorUniversity of Erlangen-Nürnberg Medical School