Kidney DiseasesNCT05112315
Clinical Impact of the IBox As an Early Intervention TooL
A study testing Predigraft in people with Kidney Diseases and Kidney Disease, Chronic, run by Predict4Health at 16 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases, Kidney Disease, Chronic, Kidney Transplant Rejection
- What is being tested?
- Predigraft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 507 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 18 Feb 2022to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
United Kingdom5 sites
Queen Elizabeth Hospital
Birmingham, B15 2GW
Leeds Teaching Hospital NHS Trust
Leeds, LS9 7TF
Guy's & Saint Thomas' NHS Foundation Trust
London, SE1 9RT
King's College Hospital
London, SE5 9RS
Oxford Transplant Centre
Oxford, OX3 7LE
France4 sites
Hôpital Saint-Louis
Paris, France, 75010
Hôpital Tenon
Paris, France, 75020
Hôpital Necker
Paris, 75015
CHU Rangueil
Toulouse, France, 31400
Spain3 sites
Hospital Del Mar - Parc de Salut Mar
Barcelona, 08003
Fundació Puigvert
Barcelona, 08025
Hospital Universitari i Politècnic La Fe
Valencia, 46026
Germany2 sites
Universitätsklinikum Düsseldorf AÖR
Düsseldorf, 40225
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20251
About this study
Official 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.
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.
Read the 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.
- Conditions
- Kidney Diseases, Kidney Disease, Chronic, Kidney Transplant Rejection, Kidney Transplant; Complications, Kidney Failure, Kidney Failure, Chronic
- Being tested
- Predigraft
- Keywords
- Chronic Kidney Disease, Kidney Transplant, IBox, Predigraft, Kidney allograft, Prediction, Rejection, Allograft survival
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic, Renal Insufficiency, Kidney Failure, Chronic, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PredigraftDevice
Also called Remote monitoring
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.
| Study group | Role | What they receive |
|---|---|---|
| Predigraft | Experimental | Subjects will have a clinical follow-up based on site standard of care and benefit from follow-up using Predigraft in addition of the standard of care: the investigator will receive an alert every time there is a subject's instability, instability based on the following criteria: allograft survival assessed by iBox decreased by at least 5% in the last 12 months. Receives: Device: Predigraft |
| Standard of Care | No intervention | Subjects will have a clinical follow-up based on site standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of biopsies leading to therapeutic change
number of biopsies leading to therapeutic change by the end of the follow-up (18 months).
Measured: 18 months
Secondary outcomes (6)
Lapse of time between the detection of kidney allograft instability and the biospy
Lapse of time between the detection of kidney allograft instability (i.e. Predigraft alert on patient's instability) and performing the biopsy.
Measured: 18 months
Renal function
Renal function estimated by eGFR
Measured: 18 months
Patient outcome
Patient outcome evaluated by a composite endpoint: graft loss + patient death + eGFR < 30 mL/min/1.73m2 by the end of the follow-up.
Measured: 18 months
iBox predicted allograft survival
iBox predicted allograft survival: 7-year kidney allograft predictions by the end of the follow-up.
Measured: 18 months
Number of therapeutic changes
Number of therapeutic changes by the end of the follow-up.
Measured: 18 months
Number of unnecessary biopsies
Number of unnecessary biopsies by the end of the follow-up.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start18 Feb 2022
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized 1:1 , controlled, open label study
- Masking
- None (open label)
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Predict4Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandre LOUPY, Pr, Study chair, Necker Hospital, Paris, FranceCarmen LEFAUCHEUR, Pr, Principal investigator, St Louis Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112315
- Sponsor's protocol ID
- TF-Form-124
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2021
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be communicated to other researchers in an aggregated manner
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05112315
- Acronym / sponsor ID
- TF-Form-124
- Conditions
- Kidney Diseases, Kidney Disease, Chronic, Kidney Transplant Rejection, Kidney Transplant; Complications, Kidney Failure, Kidney Failure, Chronic
- Keywords
- Chronic Kidney Disease, Kidney Transplant, IBox, Predigraft, Kidney allograft, Prediction, Rejection, Allograft survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 507 participants (actual)
- Lead sponsor
- Predict4HealthIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized 1:1 , controlled, open label study
| Arm | Type | Receives |
|---|---|---|
| Predigraft | Experimental | Device: PredigraftSubjects will have a clinical follow-up based on site standard of care and benefit from follow-up using Predigraft in addition of the standard of care: the investigator will receive an alert every time there is a subject's instability, instability based on the following criteria: allograft survival assessed by iBox decreased by at least 5% in the last 12 months. |
| Standard of Care | No intervention | –Subjects will have a clinical follow-up based on site standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PredigraftAlso: Remote monitoringThe 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. | Device | Predigraft |
Primary outcome
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).
6 secondary outcomes
Lapse of time between the detection of kidney allograft instability and the biospy
Time frame: 18 months
Renal function
Time frame: 18 months
Patient outcome
Time frame: 18 months
iBox predicted allograft survival
Time frame: 18 months
Number of therapeutic changes
Time frame: 18 months
Number of unnecessary biopsies
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No. Data will be communicated to other researchers in an aggregated manner
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre LOUPY, Pr study chair
Necker Hospital, Paris, France
Carmen LEFAUCHEUR, Pr principal investigator
St Louis Hospital, Paris, France
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predigraft in people with Kidney Diseases and Kidney Disease, Chronic, run by Predict4Health at 16 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom, France, Spain, Germany, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of biopsies leading to therapeutic change (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.