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Kidney Transplantation clinical trials

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NCT ID: NCT05747053 Terminated - Kidney Diseases Clinical Trials

Personalization of Immunosuppressive Treatment for Organ Transplant Recipients

STAART
Start date: October 1, 2020
Phase:
Study type: Observational

Long-term graft failure rates continue to be unacceptably high despite the development of immunosuppressive drugs, underscoring the unmet need for robust prognostic biomarkers of allograft injury and failure. While rates of acute rejection (AR) continue to decrease, it remains the strongest predictor of long-term allograft survival, and so having a better understanding of factors predicting AR may contribute to more individualized patient care. Selecting optimum immunosuppressive dosage is another factor in personalizing kidney care. This project will study two areas of individualized kidney care: 1) assessing rejection by surveillance testing utilizing AlloSure, 2) developing an algorithm to select optimum immunosuppressive medication dosage.

NCT ID: NCT05044429 Terminated - Pain, Postoperative Clinical Trials

Postoperative Pain Control Following Renal Transplant

Start date: March 16, 2021
Phase: Phase 4
Study type: Interventional

This study aims to compare the effectiveness of a regional anesthetic block vs systemic intravenous (IV) lidocaine in controlling post-operative pain in kidney transplantation patients. Regional anesthetic blocks and lidocaine infusions are effective alternatives to opioid medications and are already in use at many institutions. However, there has been no prospective study comparing their effectiveness when used in conjunction with the current standard of care patient controlled analgesia (PCA) pumps. This study is a prospective, randomized evaluation of both treatment methods.

NCT ID: NCT04711850 Terminated - Clinical trials for Kidney Transplant Rejection

An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR

Start date: January 21, 2021
Phase:
Study type: Observational

The aim of this trial is to collect data and provide a better understanding of the long-term outcome of imlifidase treatment on active or chronic active antibody-mediated rejection (AMR) in kidney transplant recipients. This is done by collecting data during an extended follow-up period of 3 years of clinical study trial 16-HMedIdeS-12, in which patients received either imlifidase or plasma exchange (PE) as AMR treatment. Data for parameters such as kidney graft survival, patient survival, kidney function, treatment of rebound of donor specific antibodies (DSA) and anti-drug antibodies (ADAs) are collected.

NCT ID: NCT04280276 Terminated - Clinical trials for Kidney Transplant; Complications

TruGraf Utilization in High IPV Levels

Start date: March 2, 2020
Phase: N/A
Study type: Interventional

Intra-patient variability (IPV) in tacrolimus is associated with premature graft loss. The rate of acute rejection episodes is higher in these patients, and acute rejection impacts negatively on graft survival. The prevalence of patients with high IPV is higher in African American patients (1-5). At the kidney transplant program of the University of Maryland, our investigators follow over 2.800 patients, with approximately 50% of the patients being of African American heritage, thus an ideal setting for the study.

NCT ID: NCT04267016 Terminated - Clinical trials for Kidney Transplant Rejection

Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care

Start date: August 19, 2020
Phase:
Study type: Observational

This is an observational study in renal transplant recipients to evaluate the acceptability, feasibility, and clinical utility of TruGraf® testing in conjunction with standard clinical assessment. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.

NCT ID: NCT04266613 Terminated - Clinical trials for Kidney Transplant Rejection

TruGraf® Testing in High-Risk Kidney Transplant Recipients

Start date: February 20, 2020
Phase:
Study type: Observational

This is an observational study to evaluate TruGraf® testing in high immune risk kidney transplant recipients. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.

NCT ID: NCT04156204 Terminated - Clinical trials for Medication Adherence

Immunosuppressant Medication Dosed Daily After Kidney Transplant

Start date: November 20, 2019
Phase: Early Phase 1
Study type: Interventional

Medication non-adherence is a major risk factor for graft dysfunction and graft loss among pediatric and adult transplant recipients. Rates of non-adherence in these populations are estimated between 30 and 70%, with the highest prevalence in adolescent and young adult (AYA) transplant recipients. Treatment-related factors known to impact rates of adherence include the number of medication doses per day and the number of tablets or capsules a patient takes per day, or "pill burden". One approach to minimizing dosing frequency and pill-burden includes transitioning patients to once-daily formulations. The current literature investigating utilization of once-daily immunosuppressive regimens in the AYA kidney transplant population is limited.

NCT ID: NCT03993717 Terminated - Clinical trials for Kidney Transplant; Complications

Solid Organ Transplant SHINGRIX

Start date: January 30, 2020
Phase:
Study type: Observational

This study will assess the immune responses to the recombinant, AS01-adjuvanted varicella zoster virus subunit (HZ/su) vaccine or SHINGRIX in immunosuppressed patients, particularly those who have received a renal transplant, and aim to better understand if the vaccine and perhaps other adjuvanted vaccines are safe in these patients. 30 participants will be divided into 2 groups, one group will receive the 1st out of 2 doses of the vaccine 3-6 months after transplant per standard of care and the second group will receive the 1st out of 2 doses of the vaccine 12-36 months after the transplant per standard of care.The duration of the study is 180 days.

NCT ID: NCT03960554 Terminated - Osteoporosis Clinical Trials

The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients

ProliaKTx
Start date: January 16, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2 Multi-Center Clinical Trial (safety and effectiveness trial) in 60 patients (40 denosumab; 20 placebo) who have had a kidney transplant for 12-months or longer with more than 30% of kidney function. The investigators will test whether denosumab safely improves bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) and improves bone strength by high resolution peripheral quantitative computed tomography (HR-pQCT) in the subset of patients recruited at Columbia University Irving Medical Center. These data will inform the development and execution of a larger trial to test if denosumab prevents fractures in kidney transplant recipients.

NCT ID: NCT03866421 Terminated - Clinical trials for Chronic Kidney Diseases

NAFLD Among Patients With Chronic Kidney Disease and the Effect of Kidney Transplantation

Start date: May 29, 2019
Phase:
Study type: Observational

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in developed countries affecting approximately 30 % of the general adult population. It represents an important pathogenic factor in the development of type 2-diabetes and is associated with a high risk of cardiovascular disease. Previous studies of patients with chronic kidney disease (CKD) have demonstrated an increased risk for NAFLD and the presence of both CKD and NAFLD is likely to increase the risk for cardiovascular disease. The present protocol describes a study of the prevalence and etiology of NAFLD among patients scheduled for kidney transplantation and the possible effect of kidney transplantation on NAFLD. The project is a prospective cohort study. The effect of kidney transplantation in patients with prediabetes or normal glucose tolerance compared to healthy controls will be examined regarding development and progression of fat accumulation in the liver. Fat accumulation in the liver will be determined by magnetic resonance (MR) spectroscopy and the prevalence of NAFLD in the two groups will be investigated. A continuous glucose monitoring (CGM) for four days, Dual Energy X-ray Absorptiometry (DEXA) scanning, fibro scanning of the liver, bile acid analysis, metabolomic and lipidomic analysis will also be performed. An oral glucose tolerance test (OGTT) and an intra venous glucose infusion (IIGI) will be performed.