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End-Stage Kidney Disease clinical trials

View clinical trials related to End-Stage Kidney Disease.

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NCT ID: NCT05828823 Recruiting - Clinical trials for End-Stage Kidney Disease

Incremental Hemodialysis: The TwoPlus Trial

Start date: February 26, 2024
Phase: N/A
Study type: Interventional

This study is to prospectively compare clinical effectiveness between clinically- matched incremental hemodialysis and conventional hemodialysis in patients with incident kidney dysfunction requiring dialysis and residual kidney function.

NCT ID: NCT05806749 Recruiting - Clinical trials for Chronic Kidney Diseases

Immunological Tolerance in Patients With Mismatched Kidney Transplants

Start date: July 7, 2023
Phase: Phase 1
Study type: Interventional

This study seeks to determine if administration of the drug belumosudil (KD025) will be safe and improve transplant tolerance in subjects undergoing combined Human Leukocyte Antigen (HLA) single haplotype-matched related or 0-3 antigen (at A, B, C, DR) HLA mismatched unrelated living donor kidney and hematopoietic stem cell transplantation.

NCT ID: NCT05774392 Not yet recruiting - Clinical trials for End Stage Kidney Disease

An Observational Study of Patients With Chronic Kidney Disease

Start date: May 2023
Phase:
Study type: Observational

TARGET-KIDNEY is an observational research study to conduct a comprehensive review of outcomes for patients with chronic kidney disease (CKD) and end-stage renal disease (ESKD).

NCT ID: NCT05741489 Completed - Clinical trials for End Stage Kidney Disease

Continuous Glucose Monitoring in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes

Start date: August 10, 2022
Phase: N/A
Study type: Interventional

Twenty participants with end stage kidney disease (ESKD) and burnt-out diabetes, and 20 non-diabetic participants with ESKD will wear a continuous glucose monitoring (CGM) device for 10 days to see if the use of CGM is a better tool to assess glycemic control than glycosylated hemoglobin (HbA1c) in patients with ESKD on dialysis.

NCT ID: NCT05738330 Recruiting - Clinical trials for End Stage Kidney Disease

Symptom Monitoring in Hemodialysis

SMaRRT-HD
Start date: June 24, 2023
Phase: N/A
Study type: Interventional

The SMaRRT-HD trial is a cluster randomized trial of symptom monitoring with supported clinician follow-up using the SMaRRT-HD electronic patient reported outcome measure (ePROM) system versus Usual Care. Approximately 2400 patients at 30 geographically and racially diverse US hemodialysis clinics will be enrolled. The primary trial hypothesis is that regular symptom patient reported outcome measure (PROM) administration with supported clinician follow-up in dialysis care will reduce suffering and improve outcomes by prompting treatment of unrecognized symptoms, and enhancing patient-care team communication. Clinics randomized to the SMaRRT-HD group will adopt the use of SMaRRT-HD for 12 months. SMaRRT-HD is a symptom monitoring system that includes 1) tablet-based symptom reporting using a PROM and 2) supported clinician follow-up consisting of symptom alerts, guidances for symptom management, and symptom tracking reports that are shared with patients. Dialysis clinics randomized to Usual Care will not adopt SMaRRT-HD or any other trial-driven procedures. Usual Care clinics will monitor symptoms through clinical care interactions with participants and by administering a Health Related Quality of Life survey that includes questions about symptoms.

NCT ID: NCT05715814 Not yet recruiting - Clinical trials for End Stage Kidney Disease

meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis

CANARY
Start date: February 1, 2024
Phase: Phase 3
Study type: Interventional

The primary aim of this study is to determine the safety and mechanisms of SGLT2 inhibition in individuals on peritoneal dialysis (PD) with residual kidney function (RKF).

NCT ID: NCT05703633 Not yet recruiting - Clinical trials for End-Stage Kidney Disease

Transplantation of Uncontrolled DCD Kidneys REconditioned by a Novel Ex-VIVo Perfusion MEthod

REVIVEME
Start date: August 21, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Eight patient will be transplanted with kidneys from donors dying after uncontrolled circulatory arrest (uDCD), with prolonged warm ischemia (up to 4,5 hours), preserved by a new method based on removal of fibrinogen/fibrin in the capillary systems, leading to an effective oxygenation of the tissue using an ex-vivo hospital manufactured perfusion device, minimizing the risk for ischemia-reperfusion injury (I/R-I) after kidney transplantation.Each patient will be studied for three months, with long-term follow-up data collected at 6 and 12 months

NCT ID: NCT05685394 Recruiting - Clinical trials for End-stage Kidney Disease

DApagliflozin Cardiovascular Effects on Patients at End-stage REnal Disease

Dare-Esrd
Start date: January 24, 2023
Phase: Phase 4
Study type: Interventional

Treatment with sodium glucose co-transporter type 2 inhibitors (Sglt2i) reduced the incidence of cardiovascular death and hospitalization for heart failure by 29% in individuals with moderate chronic kidney disease. Recent observations found that beyond its effect on natriuresis, Sglt2i directly interacts with cardiomyocytes inducing improvement of myocardial function. This effect is not mitigated as glomerular filtration rate declines. Therefore, plausibly treatment with Sglt2i may attenuate heart failure in individuals end-stage kidney disease (ESKD) requiring dialysis, in whom cardiovascular disease remains the leading cause of death. In this context, this project was designed to estimate the effect of dapagliflozin on myocardial function of dialysis subjects. Individuals with diagnosed ESKD on dialysis for at least 3 months, from both sexes, aged more than 18 years of age are eligible. Exclusion criteria are pregnant woman, hepatic failure, and known allergy to study medications. Eligible patients will be recruited from the Nephrology Division of the Clinics Hospital of the University of Campinas (Unicamp). The study was designed as a prospective, randomized, open-label, phase 4 clinical trial. Patients will be randomized, 1:1, for a 6-months treatment with either dapagliflozin 10mg/day (n=40) add to standard treatment or standard treatment alone (n=40). At the randomization visit, all patients will undergo a detailed interview and medical examination by the physician-researcher, echocardiogram and blood samples will be collected for further biochemical analysis and follow up visits will be scheduled every month for endpoints disclosure and medications dispensation until the end of study participation at the 6th month visit when echocardiogram and blood sample collection will be repeated. Primary goal will be the difference between groups in mean change of NTproBNP levels during treatment. Secondary endpoints encompass the mean change in ejection fraction, e/e' ratio, global longitudinal and radial strain and indexed left ventricle mass. Changes in bone metabolsm and structure, assessed by serum levels of FGF-23 and α-Klotho, and changes in bone mineral density will be compared between groups as an exploratory analysis.

NCT ID: NCT05656040 Recruiting - Clinical trials for Kidney Failure, Chronic

A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011)

Start date: February 8, 2023
Phase: Phase 1
Study type: Interventional

This is a three-part study of MK-2060 in participants with chronic and/or end-stage kidney disease. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) or stage 5 chronic kidney disease (CKD5) participants in Part 1, of multiple subcutaneous doses in CKD4 or CKD5 participants in Part 2, and of a single subcutaneous dose of MK-2060 in participants with end-stage kidney disease in Part 3. The primary hypothesis is that, in Part 1, the true geometric mean of the area under the concentration-time curve from 0 to infinity (AUC0-inf) after a single-dose of MK-2060 in adult CKD4 or CKD5 participants is at least 11300 nM*hr.

NCT ID: NCT05642364 Not yet recruiting - Depressive Symptoms Clinical Trials

Virtual Reality in Hemodialysis to Improve Psychological Well-being

Start date: January 2023
Phase: N/A
Study type: Interventional

The long-term goal is to create behavioral health technologies to advance the science that leverages state-of-the-art technology to delivery psychotherapeutic treatment to individuals on hemodialysis (HD) to improve their emotional well-being, quality of life, and overall health. The objective in this small R01 study is to design a virtual reality (VR) platform, that fully immerses users into a fictitious lifelike environment, to deliver an evidence-based positive psychological intervention and to test whether it improves the emotional well-being of individuals on HD with comorbid depression. In this proposed 2-arm randomized controlled trial, the investigators hypothesize that delivery of psychotherapy in individuals on HD using a VR environment will prove feasible and will result in significant improvements in depressive symptoms, quality of life, and treatment adherence, along with reduced rates of hospitalization when compared to an active control condition-all while serving as a cost-effective and far-reaching platform for expansive dissemination. The Specific Aims are: Aim #1: To develop VR software to immersively deliver the skills taught in a 5-week evidence-based positive psychological intervention in individuals on HD to improve their emotional well-being. Aim #2: To evaluate the acceptability and feasibility of a 5-week positive psychological intervention, delivered using a VR platform through consideration of rates of recruitment, refusal, retention, (non)compliance, and adherence. Aim #3: To test initial efficacy of the VR-based psychotherapeutic intervention, compared to a control arm, on outcomes of depression, psychological well-being, quality of life, treatment adherence, HD sessions missed, and hospitalizations in HD patients. Knowledge gained from completion of the proposed research will result in the first VR software application to deliver psychotherapy to individuals on HD, while simultaneously allowing them to leave the confines of the clinic and virtually travel to distant regions of the world. This new therapeutic approach can be used to successfully address the added burden of psychological distress experienced by individuals on HD, with the potential to positively impact their quality of life, engagement in healthful behaviors, and overall healthy longevity. And, these findings will yield data essential for a fully-powered trial testing important health outcomes and biomarkers in individuals on HD.