NCT03562845

Evaluation of Immunobiogram® as a Tool in Adjustment of Immunosuppressant Therapy for Renal Transplant

Evaluation of the Clinical Consistency and Analytical Robustness of Immunobiogram® as an In Vitro Diagnostics Biotechnological Tool to Help Decision-making in Adjustment of Immunosuppressant Therapy for Renal Transplant

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 164 (actual)
• Sponsor: Biohope Scientific Solutions for Human Health, S.L. · Industry
• Sex: All
• Age: 25 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The trial is an observational, multi-center study to determine if a new blood test (Immunobiogram®) done after renal transplant can help predict how well the immune system is working and responding to a new kidney. These blood tests could, in the future, potentially guide how doctors manage patient's anti-rejection medication.

Detailed description

Rejection in renal transplants is a major problem unsolved in the long term, as 30-50% of patients lose their kidney due to rejection, or rejection mechanisms are involved elsewhere. One of the presumed key factors that may deliver such bad outcomes is the difficulties to personalise immunosuppressive treatment; a medical need that currently relies on immunosuppressive levels for some medications (pharmacokinetics), clinical guideline recommendations, adverse events profiles and some expensive biomarkers which are not widely used. Immunobiogram® (IMBG) is a tool that evaluates the sensitivity/resistance profile of patients to each of the most widely used and representative immunosuppressant drugs (IM). Thus, IMBG offers information that could become pivotal in clinical management of renal transplanted patients, if its potential benefits are proven. In this clinical study, a technology validation will be performed in which the robustness of the bioassay will be evaluated; and a correlation between the current clinical prognoses of each patient and resistance patterns will be explored.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
OTHER	NA-Observational only	NA-Observational only

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-04-30
• Completion: 2019-05-31
• First posted: 2018-06-20
• Last updated: 2023-12-29

Locations

1 site across 1 country: United States