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Immunosuppression clinical trials

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NCT ID: NCT05423496 Withdrawn - Kidney Transplant Clinical Trials

KidneyCare Immuno-optimization in Renal Allografts (KIRA)

Start date: August 2022
Phase: N/A
Study type: Interventional

This is an unblinded, randomized, four-arm interventional research study enrolling patients who are undergoing kidney transplantation. The aim of the study is to determine whether patients at low risk of rejection can safely reduce the doses of their post-transplant immunosuppression medications using a combination of tests that include donor-specific antibodies (DSA), histology (looking at tissue from the donor graft), and donor-derived cell-free DNA (AlloSure). Eligible participants will be randomized in a 2:1 ratio into one of two immune-optimization (intervention) arms or the corresponding observational (control) arms. Two thirds of the participants in the study will have their decision to reduce immunosuppression made based on these test results and the other third will have the decision made based on standard of care clinical assessment and laboratory testing. The study will include two additional parameters under investigation - the AlloMap Kidney gene expression profiling test and the iBox prediction algorithm, but these will not be actively used to make any decisions as part of the trial. AlloSure, AlloMap Kidney, and iBox are the three components of the KidneyCare panel developed by CareDx.

NCT ID: NCT04963673 Withdrawn - Kidney Transplant Clinical Trials

Evaluation of Interaction Between Immunosuppressive Drugs and Protein-bound Uremic Toxins in Renal Transplant Patients

DRUGTOX
Start date: July 6, 2021
Phase:
Study type: Observational

The majority of studies conducted on uremic toxins involve patients before end stage renal failure or dialysis patients. Only a few studies have focused on transplant patients. In addition, the relationship between serum concentrations of uremic toxins and immunosuppressive drug concentrations has never been studied to date. The investigator research hypothesis is that, due to the strong plasma protein binding of calcineurin inhibitors, an interaction with protein-bound uremic toxins could alter drug concentrations that explain difficulties in reaching therapeutic targets.

NCT ID: NCT04420364 Withdrawn - COVID Clinical Trials

Maintenance Versus Reduction of Immunosuppression for Renal Transplant Patients Hospitalized With COVID-19 Disease

Start date: May 3, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This will be a randomized trial of maintenance versus reduction in immunosuppression in adult patients (age >18 years old) with functioning renal transplants admitted to hospital with confirmed COVID-19 disease.

NCT ID: NCT04360772 Withdrawn - Immunosuppression Clinical Trials

Monitoring of Corticosteroids Induced Immunosuppression Using Monocyte Human Leukocyte Antigen-DR (mHLA-DR).

HLA-DR
Start date: January 1, 2023
Phase:
Study type: Observational

Corticotherapy is widely used in auto-immune diseases. If induced immunosuppression by corticosteroids is well admitted, it's currently not possible to determine individual risk of infection. Thus, the development of new biomarkers able to reflect immunological status under immunosuppressive treatments is needed. It would help identifying patients who would benefit from adapted treatment protocols or infectious prophylaxis. In this field, the mHLA-DR (monocyte Human Leukocyte Antigen-DR) has shown encouraging results. However, it has never been used in patients treated by immunosuppressive therapies. The investigators aim to describe changes induced by corticosteroids in mHLA-DR expression in vivo. To achieve this goal, the investigators will measure mHLA-DR before treatment, after 1 months, 3 months and 6 months of treatment. Finally, the investigators will look for correlation between the level of expression of mHLA-DR and the cumulated dose of corticosteroids administered.