Clinical Impact of the IBox As an Early Intervention TooL
NCT ID: NCT05112315
Last Updated: 2024-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
507 participants
INTERVENTIONAL
2022-02-18
2025-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Safety Study of Tocilizumab to Improve Transplant Rates in Highly Sensitized Patients Awaiting Kidney Transplantation
NCT01594424
Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection
NCT01154387
Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients
NCT03194321
Simulect Versus ATG in Sensitized Renal Transplant Patient
NCT02377193
TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation
NCT03943238
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Predigraft
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.
Predigraft
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.
Standard of Care
Subjects will have a clinical follow-up based on site standard of care.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Predigraft
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Patients who are unable or unwilling to comply with study procedures.
* Vulnerable patients (minors, protected adults, legally detained).
* Patients participating in other interventional studies.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Predict4Health
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alexandre LOUPY, Pr
Role: STUDY_CHAIR
Necker Hospital, Paris, France
Carmen LEFAUCHEUR, Pr
Role: PRINCIPAL_INVESTIGATOR
St Louis Hospital, Paris, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medizinische Universität Innsbruck
Innsbruck, , Austria
Hôpital Saint-Louis
Paris, France, France
Hôpital Tenon
Paris, France, France
CHU Rangueil
Toulouse, France, France
Hôpital Necker
Paris, , France
Universitätsklinikum Düsseldorf AÖR
Düsseldorf, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Sourasky Medical Center - Ichilov Hospital
Tel Aviv, , Israel
Hospital Del Mar - Parc de Salut Mar
Barcelona, , Spain
Fundació Puigvert
Barcelona, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Leeds Teaching Hospital NHS Trust
Leeds, , United Kingdom
Guy's & Saint Thomas' NHS Foundation Trust
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Oxford Transplant Centre
Oxford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TF-Form-124
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.