deltatrials
Active Not Recruiting NA INTERVENTIONAL 2-arm NCT05112315

Clinical Impact of the IBox As an Early Intervention TooL

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.

Sponsor: Predict4Health

Interventions Predigraft
Updated 13 times since 2021 Last updated: Oct 2, 2024 Started: Feb 18, 2022 Primary completion: Feb 28, 2025 Completion: Feb 28, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Kidney Disease, Chronic and Kidney Diseases and is currently ongoing. Predict4Health leads this study, which shows 13 recorded versions since 2022 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

~Dec 2021 – ~Apr 2022 · 4 months · monthly snapshot~Apr 2022 – ~Jul 2022 · 3 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Jun 2023 · 4 months · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Sep 2023 · 2 months · monthly snapshot~Sep 2023 – ~Jul 2024 · 10 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – present · 17 months · monthly snapshot

Change History

13 versions recorded
  1. Nov 2024 — Present [monthly]

    Active Not Recruiting NA

  2. Sep 2024 — Nov 2024 [monthly]

    Active Not Recruiting NA

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting NA

  4. Sep 2023 — Jul 2024 [monthly]

    Active Not Recruiting NA

  5. Jul 2023 — Sep 2023 [monthly]

    Active Not Recruiting NA

Show 8 earlier versions
  1. Jun 2023 — Jul 2023 [monthly]

    Active Not Recruiting NA

  2. Feb 2023 — Jun 2023 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  3. Jan 2023 — Feb 2023 [monthly]

    Recruiting NA

  4. Dec 2022 — Jan 2023 [monthly]

    Recruiting NA

  5. Sep 2022 — Dec 2022 [monthly]

    Recruiting NA

  6. Jul 2022 — Sep 2022 [monthly]

    Recruiting NA

  7. Apr 2022 — Jul 2022 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  8. Dec 2021 — Apr 2022 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Predict4Health
Data source: Predict4Health

For direct contact, visit the study record on ClinicalTrials.gov .