Kidney Disease, Chronic, Kidney Diseases, Kidney Dysfunction, Kidney Failure, Kidney Failure, Chronic, Kidney Transplant; Complications, Kidney Transplant Rejection
Conditions
Keywords
Chronic Kidney Disease, Kidney Transplant, IBox, Predigraft, Kidney allograft, Prediction, Rejection, Allograft survival
Brief summary
International, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device Predigraft, by showing that the use of Predigraft could improve patient's follow-up.
Detailed description
The study aims to demonstrate improvement of the prevalence of biopsies leading to therapeutic change in the Predigraft group compared to the Standard of care group in kidney transplanted patients. It is hypothesized that using Predigraft as a monitoring tool will help the physician detect earlier and more often abnormalities with the patient allograft. This should lead to an increased number of biopsies leading to therapeutic change. These biopsies should be performed earlier than without the iBox monitoring tool. This would improve long-term allograft function, kidney allograft and patient survival.
Interventions
DEVICEPredigraft
The Subject randomized to the Predigraft will benefit from Predigraft, a remote monitoring software that issues an alert to the investigator when the allograft survival prediction calculated by the iBox algorithm is decreasing. This follow-up is on top of the site's standard of care.
Sponsors
Predict4Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
randomized 1:1 , controlled, open label study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women, age ≥ 18 years old at the time of consent. * Patients receiving a living or deceased donor kidney allograft. * Patients transplanted at least 3 months before inclusion. * Patients who signed the informed consent form and are willing to comply with study procedures.
Exclusion criteria
* Combined transplant (i.e. heart-kidney, liver-kidney). * Patients who are unable or unwilling to comply with study procedures. * Vulnerable patients (minors, protected adults, legally detained). * Patients participating in other interventional studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of biopsies leading to therapeutic change | 18 months | number of biopsies leading to therapeutic change by the end of the follow-up (18 months). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lapse of time between the detection of kidney allograft instability and the biospy | 18 months | Lapse of time between the detection of kidney allograft instability (i.e. Predigraft alert on patient's instability) and performing the biopsy. |
| Renal function | 18 months | Renal function estimated by eGFR |
| Patient outcome | 18 months | Patient outcome evaluated by a composite endpoint: graft loss + patient death + eGFR \< 30 mL/min/1.73m2 by the end of the follow-up. |
| Number of therapeutic changes | 18 months | Number of therapeutic changes by the end of the follow-up. |
| Number of unnecessary biopsies | 18 months | Number of unnecessary biopsies by the end of the follow-up. |
| iBox predicted allograft survival | 18 months | iBox predicted allograft survival: 7-year kidney allograft predictions by the end of the follow-up. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient related outcome measures | 18 months | Patient related outcome measures: results of SF-36 (36-Item Short Form Health Survey) (quality of life: score 0 to 100 / 0 being the worst perception of health status) questionnaire at the end of the follow-up compared to baseline. |
| Medico-economic evaluation | 18 months | Medico-economic evaluation based on days of hospitalization, treatment cost and return to dialysis at 18 months |
Countries
Austria, France, Germany, Israel, Spain, United Kingdom
Outcome results
None listed