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 range1 Year – 99 Years
SexALL
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 (…
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-NĂĽrnberg Medical School