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Kidney Diseases clinical trials

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NCT ID: NCT05597982 Withdrawn - Kidney Diseases Clinical Trials

How Do Structural Social Determinants of Health Affect AKT-MP and Outcomes

Start date: July 31, 2023
Phase: N/A
Study type: Interventional

Our parent award compares two patient-centered methods to facilitate KT evaluation: kidney transplant fast track (FT), a streamlined KT evaluation process; and peer navigators (PN), a peer assisted evaluation program that incorporates motivational interviewing. This pragmatic randomized trial uses a comparative effectiveness approach to assess whether FT or PN can help patients overcome barriers to transplant listing. The aims of the parent study are to: (1) compare FT and PN to assess improvements in kidney transplant (KT) related outcomes and cost effectiveness; (2) examine how each approach effects changes in cultural/contextual factors, concerns about, and ambivalence to KT; and (3) develop a framework for widespread implementation of either approach. Recent guidelines encourage using PhenX toolkit measures for kidney-disease research and clinical data reporting, but research to date has been limited by cross sectional or retrospective analyses, and incomplete or missing data on key variables, and show limited clinical application or interventions. In addition to the several PhenX individual social determinants of health (SDOH) already collected for the parent award, we propose to add PhenX structural SDOH, including concentrated poverty, food swamp, race/ethnic segregation, and social vulnerability, to our baseline data collection for all 398 patient participants under the proposed administrative supplement. Also, we will add a third assessment to determine how and whether the intervention affected post-transplant outcomes. We will follow patients via their medical records through receipt of KT to determine time to receive transplant (from time evaluation started), and type of transplant received (living or deceased donor KT). At ~6 months post-KT, participants will complete a third interview to assess KT patient reported outcomes, including health-related quality of life (QOL) and satisfaction with service.

NCT ID: NCT04896567 Withdrawn - Clinical trials for Endothelial Dysfunction

Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair

Start date: January 21, 2022
Phase: Phase 1
Study type: Interventional

Endothelial progenitor cells that reside in renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells resident in the kidney can transition to a post-injury phenotype that promotes endothelial repair.

NCT ID: NCT04665310 Withdrawn - Clinical trials for Acute Rejection of Renal Transplant

Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant

Start date: September 1, 2018
Phase: Phase 4
Study type: Interventional

In spite of conventional immunosuppression with lymphocyte-depleting induction followed by tacrolimus- and mycophenolate-based regimens, African American (AA) renal transplant recipients experience higher rates of acute rejection (AR), donor specific antibodies (DSA), and graft failure. Envarsus Extended-Release (XR)® (ENV) is a novel extended-release formulation of tacrolimus with a favorable pharmacokinetic profile, even in the setting of CYP3A5*1 allele (rapid metabolizers). The investigator will evaluate the safety and efficacy of early dose escalation with ENV in AA recipients. The study hypothesis is that higher tacrolimus target concentrations may be achieved without typical dose-limiting toxicities, and this may ultimately result in lower incidence of early AR, DSA, and graft loss.

NCT ID: NCT03623568 Withdrawn - Hepatitis C Clinical Trials

Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant

Start date: February 15, 2019
Phase: Phase 4
Study type: Interventional

This is a proof of concept, single center study for the donation of HCV-positive kidney to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

NCT ID: NCT03416140 Withdrawn - Exercise Clinical Trials

Effectiveness Chronic Kidney Disease & Therapeutic Exercise

Start date: February 15, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effectiveness and safety of the therapeutic exercise effects in patients with chronic kidney disease. An randomized clinical trial is carried out. A total sample of 70 patients with chronic kidney disease is recruited and divided into a therapeutic exercise group and a control group. The kidney function (creatinine clearance as main outcome) is measured at baseline and 1 month after treatment start.

NCT ID: NCT03159806 Withdrawn - Kidney Diseases Clinical Trials

Detecting Markers of Kidney Function With Intravenous Microdialysis

Start date: July 1, 2019
Phase:
Study type: Observational

Patients will be invited to participate from an outpatient nephrology clinic at Hammersmith Hospital. They will have a microdialysis catheter inserted into a peripheral vein and connected to a sampling system. The samples will be sent for analysis in the hospital laboratory. All medical devices to be used are already CE-marked and approved for these purposes.

NCT ID: NCT02325024 Withdrawn - Renal Insufficiency Clinical Trials

A Study to Evaluate the Pharmacokinetics Of Sativex® in Subjects With Severe Renal Impairment or End Stage Renal Disease, Compared to Matched Subjects With Normal Renal Function.

Start date: January 2016
Phase: Phase 1
Study type: Interventional

The study aims to determine the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) when subjects have severe renal impairment or end stage renal disease (ESRD), compared with subjects who have normal renal function. The primary clinical hypothesis is that there will be an effect from severe renal impairment on the PK of Sativex® when administered as a single oromucosal dose. The study additionally aims to evaluate the safety and tolerability of the same single oromucosal dose of Sativex® in subjects with severe renal impairment or ESRD.

NCT ID: NCT02006849 Withdrawn - Kidney Disease Clinical Trials

ACTH Treatment of APOL1- Associated Nephropathy

Start date: January 2014
Phase: N/A
Study type: Interventional

The purpose of this research study is to determine if the study drug H.C. Acthar gel slows the progression of your kidney disease. This drug is a steroid-based medicine with fewer side effects than other steroids used for treatment of kidney diseases similar to APOL1 nephropathy.

NCT ID: NCT01343641 Withdrawn - Clinical trials for Chronic Kidney Disease

Growth Hormone Secretagogue MK-0677's Effect on Lean Body Mass in Chronic Kidney Disease Stage 4/5 Subjects

Start date: March 2009
Phase: Phase 2
Study type: Interventional

This year-long investigator-initiated study is designed to determine effects of MK-0677, a GH secretagogue, in renal patients. It is a double-blind, placebo-controlled trial employing the following procedures: Informed consent process, followed by evaluation and screening tests to confirm patients' eligibility. Patients whose screening laboratory results for glycated hemoglobin level, thyroid function, or liver function exceed protocol eligibility criteria will not be randomized. Other exclusions are Congestive Heart Failure Class III or IV by the New York Heart Assocation's (NYHA) Guidelines and specified cardiovascular disorders within six months of baseline visit and muscle weakness associated with neuromuscular or neurological disorders. Before the subject begins taking the experimental drug MK-0677 or placebo, baseline assessments of subjects' hormone and cytokine levels, physical condition, body mass (determined by a DEXA scan), strength and functionality, and appetite will be obtained. In addition, quality of life assessments (SF-36) will be administered. This study's primary outcome is an increase in lean body weight. Secondary outcomes are cytokine and hormone levels, including, leptin, insulin, ghrelin, TNF- alpha, CRPs, IL-1, IL-6, and IL-10, ghrelin associated esterase and adiponectin, nutritional status, quality of life (QoL), food appreciation, physical function and economic impact. 70 subjects will be the enrollment target. This number was determined to offset projected screen failure and early withdrawal rates, and to ensure that 42 subjects complete the study.

NCT ID: NCT00585429 Withdrawn - Clinical trials for Liver Transplantation

Evaluation of Kidney Disease in Liver Transplant Recipients

Start date: September 2006
Phase: N/A
Study type: Observational

A non-invasive urinary test that detects kidney injuries in liver transplant (LT) candidates would be useful for monitoring of kidney damage. Particularly, the ability to predict irreversibility of such renal damage or progressive nature of renal disease in LT candidates would be of importance to determine the need for dual kidney-liver transplantation (KLT) versus LT alone. We will correlate kidney histology with cytokine/chemokine profile expression in the urine as a potentially useful noninvasive diagnostic tool.