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Kidney Transplantation clinical trials

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NCT ID: NCT04910867 Recruiting - Clinical trials for Chronic Kidney Diseases

APOL1 Genetic Testing Program for Living Donors

Start date: September 9, 2021
Phase: N/A
Study type: Interventional

Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly using APOL1 testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counseling with LD candidates about APOL1 due to a lack of knowledge and skill in counseling about APOL1. Without proper counseling, APOL1 testing will magnify LD candidates' decisional conflict about donating, jeopardizing their informed consent. Given their elevated risk of ESRD post-donation, and AAs' widely-held cultural concerns about genetic testing, it is ethically critical to protect AA LD candidates' safety through APOL1 testing in a culturally competent manner to improve informed decisions about donating. No transplant programs have integrated APOL1 testing into LD evaluation in a culturally competent manner. Clinical "chatbots," mobile apps that use artificial intelligence to provide genetic information to patients and relieve constraints on clinicians' time, can improve informed treatment decisions and reduce decisional conflict. The chatbot "Gia," created by a medical genetics company, can be adapted to any condition. However, no chatbot on APOL1 is currently available. No counseling training programs are available for nephrologists to counsel AA LDs about APOL1 and donation in a culturally competent manner. Given the shortage of genetic counselors, increasing nephrologists' genetic literacy is critical to integrating genetic testing into practice. The objective of this study is to culturally adapt and evaluate the effectiveness of an APOL1 testing program for AA LDs at two transplant centers serving large AA LD populations (Chicago, IL, and Washington, DC). The APOL1 testing program will evaluate the effect of the culturally competent testing, chatbot, and counseling on AA LD candidates' decisional conflict about donating, preparedness for decision-making, willingness to donate, and satisfaction with informed consent. The specific aims are to: 1. Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice 2. Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design 3. Evaluate the implementation of this intervention into clinical practice by using the RE-AIM framework to longitudinally evaluate nephrologist counseling practices and LDs' satisfaction with informed consent. The impact of this study will be the creation of a model for APOL1 testing of AA LDs, which can then be implemented nationally via implementation science approaches. APOL1 will serve as a model for integrating culturally competent genetic testing into transplant and other practices to improve patient informed consent.

NCT ID: NCT04906213 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

CardioRenal Effects of SGLT2 Inhibition in Kidney Transplant Recipients

CREST-KT
Start date: July 25, 2022
Phase: Phase 2
Study type: Interventional

CREST-KT is a single-center, double-blinded, randomized trial of empagliflozin therapy in 72 kidney transplant recipients with (n=36) and without type 2 diabetes (n=36). After evenly dividing patients by type 2 diabetes diagnosis, patients will be randomized 2:1 to empagliflozin 10mg versus placebo.

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: NCT04899167 Completed - Clinical trials for Kidney Transplantation

Noninvasive Evaluation of Renal Allograft Fibrosis by MRI

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to validate an MRI method to detect renal fibrosis in patients after kidney transplantation (KT).

NCT ID: NCT04897438 Active, not recruiting - Clinical trials for Kidney Transplant Rejection

Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection

cfDNA-DSA
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Patients after kidney transplantation who develop donor-specific antibodies (DSA) are at high risk for antibody-mediated rejection (ABMR). Donor-derived cell-free DNA (dd-cfDNA) levels have been shown to be increased in patients with active or chronic active ABMR. This study aims to evaluate if repeated analysis of dd-cfDNA in patients with DSA and kidney allograft biopsy which is triggered by increased levels of dd-cfDNA can lead to early diagnosis of active or chronic active ABMR among these patients.

NCT ID: NCT04882254 Active, not recruiting - Clinical trials for Chronic Kidney Failure

Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes?

APOLLO
Start date: May 1, 2021
Phase: Phase 2
Study type: Interventional

This study is a randomised, controlled, phase II trial to assess the efficacy of 2 hours normothermic machine perfusion (NMP) of extended criteria(EC)-DBD (donation after brain death) and DCD (donation after circulatory death) donor kidneys compared to standard care, which is hypothermic machine perfusion (HMP) only in the Netherlands.

NCT ID: NCT04870437 Not yet recruiting - Clinical trials for Kidney Transplantation

Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.

IPECAM
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Chronic AntiBody-Mediated Rejection (cABMR) is the leading cause of late kidney transplant loss (after 1 year of kidney transplantation). Its therapeutic management is poorly codified and there is currently no treatment referring. Extracorporeal phototherapy (ECP) is a therapeutic apheresis that involves purifying mononucleated cells in the blood, exposing them to UltraViolet A (UVA) and re-injecting them to the patient. This treatment is used as common care in the first line as part of the treatment of cutaneous T lymphoma and in the second line as part of the graft versus host reaction after bone marrow allograft. The mechanisms underlying the action of the ECP are not well known. They are mediated by the reinjection of cells exposed to UVA which enter apoptosis and induce immunomodulation. Recent work during cABMR shows that TFH lymphocytes, the maturing population of B lymphocytes, are deregulated and activated. The hypothesis is that ECP can modulate T Follicular Helper (TFH) lymphocytes during cABMR.

NCT ID: NCT04851145 Recruiting - Clinical trials for Kidney Transplantation

Mass Spectrometry-based Proteomics in Microvascular Inflammation Diagnosis in Kidney Transplantation.

TranSpec
Start date: November 8, 2021
Phase: N/A
Study type: Interventional

Microvascular inflammation, the hallmark histological criteria of antibody-mediated rejection in kidney transplantation, remains an issue in routine practice, due to a lack of reproducibility in its recognition by pathologists and an incomplete comprehension of its pathophysiology, leading to a poor treatment efficacy. The main objective of this study is to assess the performances of tissue proteic signatures designed for the diagnosis of microvascular inflammation in kidney transplantation, from formalin-fixed and paraffin-embedded (FFPE) allograft biopsies analyzed by mass spectrometry-based proteomics.

NCT ID: NCT04849533 Recruiting - Clinical trials for Kidney Transplant Rejection

Belatacept With Early Steroid Withdrawal rATG and Everolimus in Renal Transplantation (BETTER Trial)

BETTER
Start date: April 9, 2021
Phase: Phase 4
Study type: Interventional

This study is designed to determine the safety and efficacy of two calcineurin inhibitor free treatment groups 1) a belatacept, everolimus and early corticosteroid withdrawal (ECSWD) immunosuppressive regimen with rabbit antithymocyte globulin induction (rATG) and 2) a belatacept, mycophenolate, chronic steroid regimen with rATG and compare to historical controls of tacrolimus-based and belatacept-based regimens in combination with rATG induction, mycophenolate, and ESWD in renal transplant recipients. The purpose is to evaluate the effect of 2 regimens (rATG induction/belatacept/everolimus/ESWD and rATG induction/belatacept/mycophenolate/CS) on the composite of patient death, graft loss, or eGFR (MDRD) < 45 mL/min/1.73m2 at Month 12 post-transplantation compared to historical controls of the BEST Trial (groups B and C).

NCT ID: NCT04842591 Recruiting - Clinical trials for Pulmonary Hypertension

Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation

Start date: December 23, 2020
Phase:
Study type: Observational

The aim of the study is to investigate pulmonary hemodynamics at rest and during exercise in patients before and after kidney transplantation.