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OpenTrials
Active, Not Recruiting

NCT Number: NCT05112315

Clinical Impact of the IBox As an Early Intervention TooL

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Kidney Diseases Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Disease, Chronic Kidney Dysfunction Kidney Failure Kidney Failure, Chronic Kidney Transplant Rejection Kidney Transplant; Complications Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rejection, Psychology Renal Insufficiency Renal Insufficiency, Chronic Social Behavior Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Universität Innsbruck, Innsbruck, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Predigraft

Device

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.

Other names: Remote monitoring

Primary outcomes

  1. number of biopsies leading to therapeutic change

    Time frame: 18 months

    number of biopsies leading to therapeutic change by the end of the follow-up (18 months).

Secondary outcomes

  1. Lapse of time between the detection of kidney allograft instability and the biospy

    Time frame: 18 months

    Lapse of time between the detection of kidney allograft instability (i.e. Predigraft alert on patient's instability) and performing the biopsy.

  2. Renal function

    Time frame: 18 months

    Renal function estimated by eGFR

  3. Patient outcome

    Time frame: 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.

  4. iBox predicted allograft survival

    Time frame: 18 months

    iBox predicted allograft survival: 7-year kidney allograft predictions by the end of the follow-up.

  5. Number of therapeutic changes

    Time frame: 18 months

    Number of therapeutic changes by the end of the follow-up.

  6. Number of unnecessary biopsies

    Time frame: 18 months

    Number of unnecessary biopsies by the end of the follow-up.

Other outcomes

  1. Patient related outcome measures

    Time frame: 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.

  2. Medico-economic evaluation

    Time frame: 18 months

    Medico-economic evaluation based on days of hospitalization, treatment cost and return to dialysis at 18 months

Sponsors and collaborators

Lead sponsor

Predict4Health

Industry

Registry information

Official study title

Clinical Impact of the IBox As an Early Intervention TooL: a Prospective Randomised Controlled Trial to Assess the Use of a Software Predicting Allograft Survival in the Follow-up of Kidney Transplanted Patients.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2021
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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