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Kidney Transplantation clinical trials

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NCT ID: NCT05811468 Withdrawn - Kidney Transplant Clinical Trials

Study Correlation Between Blood, Tissue Gene Expression, Donor Derived Cell Free DNA and Histopathology in Kidney Transplant Recipients

Start date: September 26, 2023
Phase:
Study type: Observational

This study will compare the performance of Gene Expression Profile (GEP)/ Donor derived cell free deoxyribonucleic acid (dd-cfDNA) tests, to the following tests: Molecular Microscope (MMDx) and histopathology (study of changes in tissues caused by disease) in their ability to diagnose (exactly identify) various types of injury within the transplanted kidney.

NCT ID: NCT05423496 Withdrawn - Kidney Transplant Clinical Trials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NCT ID: NCT05387343 Withdrawn - Clinical trials for End Stage Renal Disease

COVID Vaccine Immunity in Kidney Transplant Recipients

Start date: November 2022
Phase:
Study type: Observational

50 end-stage renal disease (ESRD) patients whom have had at least 2 doses of messenger ribonucleic acid (mRNA) vaccine, and undergoing transplantation at the University of Alabama at Birmingham (UAB) will be enrolled. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.

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: NCT04936971 Withdrawn - Clinical trials for Kidney Transplantation

Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response

ACTIVA
Start date: September 2021
Phase: Phase 4
Study type: Interventional

Kidney transplant patients under an immunosuppressive treatment based on anti-calcineurin and mycophenolate-mofetil and induction therapy with rATG who suffer from early systemic viral replication by the CMV virus could benefit from the introduction of an i-mTor drug. (everolimus) to replace mycophenolate mofetil. This conversion would be effective in slowing down and controlling viral expansion without the need to initiate any prophylactic anti-viral therapy thanks to the activation of the CMV-specific cellular effector response or to an antiviral effect of i-Mtor itself.

NCT ID: NCT04903054 Withdrawn - Clinical trials for Kidney Transplantation

Selective CD28 Blockade in Renal Transplant Recipients

Start date: January 10, 2022
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the safety and efficacy of lulizumab, a CD28-specific domain antibody (CD28 dAb), compared to tacrolimus, as the primary immunosuppressant in first-time renal transplant recipients.

NCT ID: NCT04827186 Withdrawn - Clinical trials for Kidney Transplant Rejection

Spleen Transplant in Solid Organ Transplantation

Start date: March 26, 2021
Phase: N/A
Study type: Interventional

Although the notions that kidney transplantation is the treatment of choice for patients with end-stage renal disease and that simultaneous kidney and pancreas transplant is the only treatment able to restore euglycemia in patients with type 1 diabetes and selected patients with type 2 diabetes, are now consolidated, rates of transplantation remain low among potential candidates with high levels of preformed anti-HLA antibodies. Most of the data comes from the experience in kidney transplant but can be easily translated to pancreas transplant. Approximately 30% of patients on the transplant waiting list have evidence of sensitization in the form of alloantibodies, generated from exposure to previous transplants, blood transfusions, pregnancy, or other events. The presence of a panel-reactive antibody level of at least 80% (i.e. a high level of sensitization) creates difficulty in finding matched kidneys from compatible donors, leading to lower rates of transplantation in highly sensitized candidates compared to non-sensitized; the longer waiting times translates in an increased mortality rate. Despite the development of desensitization strategies and the advancement in immunosuppression protocols, it is apparent that transplanting these patients carries an increased risk of acute antibody mediated rejection; 25%-50% of transplants will have an early acute antibody mediated rejection . Most of these rejections can be successfully treated, but a high rate of transplant glomerulopathy and chronic antibody mediated rejection (AMR) leading to accelerated allograft failure is common.

NCT ID: NCT04560582 Withdrawn - Clinical trials for Kidney Transplant; Complications

Immunosuppression Reduction in Failed Allograft Guided by cfDNA

Start date: September 22, 2022
Phase:
Study type: Observational

The optimal timing for immunosuppression tapering for patients with failed kidney transplant is not known. This pilot study would be to correlate rise in cf-DNA and increase in cPRA.

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: NCT04275752 Withdrawn - Kidney Transplant Clinical Trials

Exercise Intervention on Frailty After Kidney Transplantation

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Researchers are trying to determine if exercise will improve health and strength in kidney transplant patients.