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BIOtechnology Applied to Renal TRansplantation With IMmunobiogram

NCT05816486 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 443

Last updated 2024-07-18

No results posted yet for this study

Summary

Immunobiogram (IMBG) is a novel in vitro diagnostic bioassay developed by Biohope Scientific Solutions for Human Health SL, that allows to measure the pharmacodynamic response to individual immunosuppressive drugs in patients with a renal transplantation. Pharmacodynamics can complement the already available pharmacokinetic information on immunosuppressants and enable a more individualized evaluation of the immunosuppressive therapy.

The aim of this study is to evaluate the association between the pharmacodynamic response to individual immunosuppressants taken by the patient measured in vitro with IMBG and the existence of signs of graft rejection in biopsies (upon indication or protocol) performed in a sample of kidney transplant patients.

The main hypothesis is that a lower sensitivity to the immunosuppressive drugs taken by the patient will be associated with a higher probability of rejection.

Conditions

  • Kidney Transplant Failure and Rejection

Interventions

DIAGNOSTIC_TEST

Immunobiogram

This is not an interventional study. However the assay being tested on the blood samples of all enrolled participants is the Immunobiogram (IMBG). IMBG is an in vitro diagnostic immunoassay which can obtain dose-response curves that describe the inhibitory effect of each immunosuppressant on immune response cells (immunologically stimulated PBMCs) in kidney transplant patients.

Sponsors & Collaborators

  • Biohope Scientific Solutions for Human Health, S.L.

    lead INDUSTRY

Principal Investigators

  • Isabel Portero · Biohope Scientific Solutions for Human Health, S.L.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Brazil
  • France
  • Germany
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05816486 on ClinicalTrials.gov