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

01NVF21116

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.

2023-05-15

2025-04-30

2025-04-30

Recruiting

384

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).

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, two-armed randomized controlled trial (RCT)', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 384, 'type': 'ESTIMATED'}}

2023-06-09