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End-Stage Kidney Disease clinical trials

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NCT ID: NCT06398002 Not yet recruiting - Clinical trials for Secondary Hyperparathyroidism

The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism and ESKD

CaT50HD
Start date: August 1, 2024
Phase: Phase 2
Study type: Interventional

Patients with end-stage kidney disease (ESKD) have an increased risk of cardiovascular mortality. High parathyroid hormone (PTH) from secondary hyperparathyroidism leads to increased efflux of phosphate and calcium from bone, which exacerbates vascular calcification and increases the risk of bone fractures. The main driving factor for secondary hyperparathyroidism is hypocalcaemia caused by low levels of 1,25-dihydroxy vitamin D and pharmacological supplementation with activated vitamin D and oral calcium-containing phosphate-binders are used to control secondary hyperparathyroidism. The amount of calcium used in this context is controversial, as higher calcium load in blood may theoretically increase vascular calcification. Conversely, by alleviating the efflux of phosphate and calcium from bone due to secondary hyperparathyroidism, increasing the load of calcium might actually prevent vascular calcification. To study this further, we wish to conduct a randomised double-blinded controlled clinical trial of increasing dialysate Ca from 1.25 mmol/L (standard dialysate concentration) to 1.50 mmol/L in patients with ESKD and secondary hyperparathyroidism on maintenance haemodialysis (HD). The overall effect of increased dialysate calcium will be gauged by its effect on serum calcification propensity (T50) and on markers of bone turnover.

NCT ID: NCT06377293 Not yet recruiting - Clinical trials for End-Stage Kidney Disease

Effect of Dialysis-specific Therapeutic Diet on Biochemical Parameters in Dialysis Patients

Start date: November 2024
Phase: N/A
Study type: Interventional

In patients with kidney failure, disturbances in bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, nutrition, and gut microbial metabolites are frequent. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, inflammation, protein-energy wasting and dysbiosis. The investigators hypothesize that therapeutic diet intervention reverses these uremic complications and thereby reduces cardiovascular risk in patients with kidney failure. In this study, the investigators crafted 4-week dialysis-specific therapeutic diet to illustrate the clinical implications of therapeutic diet for dialysis patients.

NCT ID: NCT06356168 Not yet recruiting - Clinical trials for End Stage Kidney Disease

Virtual Reality in End Stage Kidney Disease

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial to compare the social virtual reality and individual virtual reality in patients with end stage kidney disease who are hemodialysis. The main aim is to determine if there are differences in symptoms between the groups. Participants will use virtual reality glasses for 30-45 minutes during dialysis sessions for 4 weeks.

NCT ID: NCT05957146 Not yet recruiting - Clinical trials for End-stage Kidney Disease

Kinetics of Extracellular Vesicles in Hemodialysis

Start date: August 2023
Phase:
Study type: Observational

The aim of this observational study is to gain insight into the kinetics of extracellular vesicles (EVs), derived from both in- (i.e. bio-incompatibility) and outside (tissue-injury) the extracorporeal circuit (ECC), during standard hemodialysis (HD) in adult prevalent end-stage kidney disease (ESKD) patients treated with HD. During a single HD session, blood samples for EV-assessment will be taken at several time points and at different sampling sites in the extracorporeal circuit (sampling point 1: before the rollerpump, arterial line; sampling point 2: after the rollerpump and before the dialyzer, sampling point 3: after the dialyzer, efferent line).

NCT ID: NCT05879302 Not yet recruiting - Clinical trials for End Stage Renal Disease

Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The goal of this pilot randomized trial is to learn about shared decision making in kidney transplant candidates. The aim of this proposal is to evaluate the Donor Plan Donor Choice tool to promote high-quality Shared Decision Making for providers and kidney transplant candidates at two transplant centers. Participants will: - Review an online education tool, Donor Plan Donor Choice. - Discuss a Kidney Offer Plan with a transplant provider. - Answer questions about willingness to consider different donor types. Researchers will compare the Shared Decision Making group to usual care to generate pilot data and implementation outcomes for a larger trial.

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

meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis

CANARY
Start date: June 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: 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.

NCT ID: NCT05558267 Not yet recruiting - Clinical trials for End Stage Kidney Disease

Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease

Start date: July 31, 2024
Phase: N/A
Study type: Interventional

16 individuals with hemodialysis-dependent end stage kidney disease will receive 16 days of a potassium-containing salt-substitute and 16 days of standard table salt in random order. There will be a 19 day wash out period between the salt-substitute and table salt periods. Potassium concentration will be measured bi-weekly prior to HD each week during intervention. The primary endpoint will be the change in potassium from baseline. Additional measurements will include assessment of dietary intake, ambulatory blood pressure, occurrence of peri-dialytic symptoms, and per-dialytic vital signs.