Kidney Transplant Failure and Rejection Clinical Trial
Official title:
Longitudinal Observational Study to Determine the Correlation Between Patient's Pharmacodynamic Response to Immunosuppressants Measured in Vitro With IMMUNOBIOGRAM and of Rejection in Graft Biopsies in Patients With Renal Transplantation
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.
Immunobiogram (IMBG) is a novel bioassay that allows to measure in vitro the inhibitory effect of a battery of individual immunosuppressants on the patient's immune cells (immunologically stimulated PBMCs). Studies conducted in kidney transplant patients have shown that IMBG is a valid and accurate instrument, capable of determining each patient's pharmacodynamic response profile to individual immunosuppressive drugs. Health professionals who monitor kidney transplant patients currently have information only on immunosuppressant pharmacokinetics to adjust the regimen of the immunosuppressants they use to treat the patients to avoid graft rejection. The pharmacodynamic measurement of the in vitro effect of each immunosuppressant in the patient could complement the pharmacokinetic information and enable more personalized approaches. The main objective of this study is to evaluate the association between the pharmacodynamic response to individual immunosuppressants taken by the patient measured with IMBG and the existence of signs of graft rejection in biopsies (upon indication or protocol) performed in a sample of kidney transplant patients. A longitudinal follow-up cohort of patients will be recruited from prior to the transplant (at sites that regularly perform a protocol graft biopsy after a year) and a cross-sectional cohort of patients will also be included when an indication biopsy is performed during the first three years after kidney transplantation due to a suspicion of rejection at sites that do not routinely perform protocol biopsies. Given that one of the main challenges that clinicians face in the follow-up of patients is to reduce the risk of renal graft rejection, while minimizing the incidence of secondary effects related to immunosuppressive therapy, it is proposed as a secondary objective to evaluate in the longitudinal cohort the incidence of "therapeutical failure" due to graft failure or due to the appearance of serious adverse effects attributable to immunosuppression and analyze its relationship with the profile of sensitivity to immunosuppressants taken by the patient measured with IMBG. Finally, the changes over time presented by the IMBG in various determinations and the correlation between IMBG results and other lymphocyte activation parameters obtained by flow cytometry will be analyzed. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04057742 -
AlloSure for the Monitoring of Antibody Mediated Processes After Kidney Transplantation
|
||
Recruiting |
NCT03465397 -
Individualization of the Immunological Risk Based on Selective Biomarkers in Living-donor Renal Recipients
|
Phase 4 | |
Completed |
NCT03437577 -
Comparison of the Cognitive and Motor Effects of Treatment Between an Immediate- and Extended-release Tacrolimus (Envarsus® XR) Based Immunosuppression Regimen in Kidney Transplant Recipients
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05282966 -
Assessment of QSantâ„¢ for Underlying Allograft Rejection
|
||
Recruiting |
NCT04388930 -
The Microbiota in Kidney Donation and Transplantation
|
||
Completed |
NCT03611621 -
A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
|
||
Recruiting |
NCT05397821 -
Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques
|
||
Completed |
NCT04019353 -
Cf-DNA Assay During Treatment of Acute Rejection
|
||
Active, not recruiting |
NCT05806749 -
Immunological Tolerance in Patients With Mismatched Kidney Transplants
|
Phase 1 | |
Recruiting |
NCT04936282 -
Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients (TRAINING)
|
Phase 4 | |
Enrolling by invitation |
NCT05285878 -
Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation
|
Phase 2 | |
Recruiting |
NCT04526431 -
Tacrolimus Pharmacokinetic Subpopulations
|
||
Active, not recruiting |
NCT03511560 -
Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation
|
Phase 4 | |
Recruiting |
NCT03438773 -
Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients
|
Phase 1 | |
Completed |
NCT05388955 -
Risk Assessment Tool for Graft Survival in Pediatric Kidney Transplantation
|
||
Completed |
NCT06394596 -
Predicting Prognostic Factors in Kidney Transplantation Using A Machine Learning
|
||
Completed |
NCT04413916 -
MiRNA in Kidney Transplantation: Association With Kidney Graft Function and Disease Process
|
||
Completed |
NCT03466775 -
Anti-Angiotensin II Type 1 Receptor Antibodies and Kidney Transplant Outcomes
|
N/A | |
Active, not recruiting |
NCT04733131 -
Long-term Outcomes After Conversion to Belatacept
|
||
Active, not recruiting |
NCT03380962 -
Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
|
Phase 1/Phase 2 |