NCT_ID: NCT05897047
Clinical Trial Link
Brief Summaries
| Sequence: | 30622923 |
| Description | 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. |
Studies
| Study First Submitted Date | 2023-05-15 |
| Study First Posted Date | 2023-06-09 |
| Last Update Posted Date | 2023-06-09 |
| Start Month Year | May 15, 2023 |
| Primary Completion Month Year | April 30, 2025 |
| Verification Month Year | May 2023 |
| Verification Date | 2023-05-31 |
| Last Update Posted Date | 2023-06-09 |
Detailed Descriptions
| Sequence: | 20627130 |
| 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. |
Facilities
| Sequence: | 199107847 | Sequence: | 199107848 |
| Status | Recruiting | Status | Not yet recruiting |
| Name | Charité Universitätsmedizin Berlin | Name | University Hospital Essen |
| City | Berlin | City | Essen |
| State | Bavaria | ||
| Zip | 10117 | ||
| Country | Germany | Country | Germany |
Facility Contacts
| Sequence: | 27997071 | Sequence: | 27997072 |
| Facility Id | 199107847 | Facility Id | 199107848 |
| Contact Type | primary | Contact Type | primary |
| Name | Klemens Budde, Prof. Dr. | Name | Lars Pape, Dr. med. |
| nephrologie-telemedizin@charite.de | lars.pape@uk-essen.de | ||
| Phone | +49 30 450 514 002 | Phone | 0201 723 2150 |
Facility Investigators
| Sequence: | 18263154 |
| Facility Id | 199107848 |
| Role | Principal Investigator |
| Name | Lars Pape, Dr. med. |
Conditions
| Sequence: | 51928728 |
| Name | Kidney Transplant Rejection |
| Downcase Name | kidney transplant rejection |
Id Information
| Sequence: | 39969241 | Sequence: | 39969242 |
| Id Source | org_study_id | Id Source | secondary_id |
| Id Value | 01NVF21116 | Id Value | 0673 |
| Id Type | Other Identifier | ||
| Id Type Description | Universitätsklinikum Erlangen | ||
Countries
| Sequence: | 42360698 |
| Name | Germany |
| Removed | False |
Design Groups
| Sequence: | 55332617 | Sequence: | 55332618 |
| Group Type | Experimental | Group Type | No Intervention |
| Title | Intervention group "Additional telemedical management" | Title | Control group "Routine posttransplant aftercare" |
| Description | 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. | Description | Patients in the control group will receive routine posttransplant aftercare. |
Interventions
| Sequence: | 52241997 |
| Intervention Type | Combination Product |
| Name | Additional interventional telemedical management |
| Description | 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. |
Keywords
| Sequence: | 79483580 | Sequence: | 79483581 |
| Name | Aftercare | Name | Telemedical Management |
| Downcase Name | aftercare | Downcase Name | telemedical management |
Design Outcomes
| Sequence: | 176536526 | Sequence: | 176536527 | Sequence: | 176536528 | Sequence: | 176536529 | Sequence: | 176536530 | Sequence: | 176536531 | Sequence: | 176536532 | Sequence: | 176536533 | Sequence: | 176536534 | Sequence: | 176536535 | Sequence: | 176536536 | Sequence: | 176536537 | Sequence: | 176536538 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Medication adherence | Measure | Unplanned hospitalizations | Measure | Length of unplanned hospitalization | Measure | Development of de-novo DSA | Measure | Tacrolimus intra-patient variability | Measure | Blood pressure control | Measure | Renal function | Measure | Reduced graft losses (result evalution) | Measure | Better prognosis of the iBox score (result evalution) | Measure | Improvement in quality of life (result evalution) | Measure | Improving disease management (process evalution) | Measure | Acceptance of the new restoration among patients (process evalution) | Measure | Acceptance of the new restoration among service providers (process evalution) |
| Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months | Time Frame | 12 months |
| Description | According to BAASIS questionnaire at month 12 | Description | yes/no during study period | Description | More/less than 10 nights during study period | Description | yes/no at month 12 | Description | Above/below 30% between month 6 to 12 | Description | normal/abnormal 24h-RR profile at month 12 | Description | suboptimal renal function (eGFR < 45 ml/min at month 12 | Description | Documentation of graft losses at all visits – Month 3, 6, 9, 12 | Description | Documentation of the prognosis of the AI during visit 5, month 12 | Description | Change in quality of life over 12 months (PROMIS 29 questionnaire) at month 0, 3, 6, 9, 12 (visit 1 to 5). | Description | Change in disease management over 12 months (PAM13 questionnaire) at month 0, 3, 6, 9, 12 (visit 1 to 5) | Description | Survey using established questionnaires and rating and satisfaction with care (own development) at Visit 4, 5 (month 9; 12) | Description | 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). |
Sponsors
| Sequence: | 48091725 | Sequence: | 48091726 | Sequence: | 48091727 |
| Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
| Name | University of Erlangen-Nürnberg Medical School | Name | Charite University, Berlin, Germany | Name | University Hospital, Essen |
Overall Officials
| Sequence: | 29143859 |
| Role | Principal Investigator |
| Name | Mario Schiffer, Prof. Dr. |
| Affiliation | Uniklinikum Erlangen |
Central Contacts
| Sequence: | 11955536 |
| Contact Type | primary |
| Name | Mario Schiffer, Prof. Dr. |
| Phone | +49(0)9131-85-39002 |
| med4@uk-erlangen.de | |
| Role | Contact |
Design Group Interventions
| Sequence: | 67833538 |
| Design Group Id | 55332617 |
| Intervention Id | 52241997 |
Eligibilities
| Sequence: | 30621704 |
| Gender | All |
| Minimum Age | 1 Year |
| Maximum Age | 99 Years |
| Healthy Volunteers | No |
| Criteria | 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). |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254021316 |
| Number Of Facilities | 2 |
| Registered In Calendar Year | 2023 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | False |
| Minimum Age Num | 1 |
| Maximum Age Num | 99 |
| Minimum Age Unit | Year |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 7 |
| Number Of Secondary Outcomes To Measure | 6 |
Designs
| Sequence: | 30368857 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Prevention |
| Time Perspective | |
| Masking | None (Open Label) |
| Intervention Model Description | Prospective, two-armed randomized controlled trial (RCT) |
Responsible Parties
| Sequence: | 28738458 |
| Responsible Party Type | Sponsor |