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Kidney Failure, Chronic clinical trials

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NCT ID: NCT04072432 Completed - Clinical trials for Kidney Failure, Acute

A Study of RBT-3 in Healthy Volunteers and Volunteers With Stage 3-4 Chronic Kidney Disease

Start date: October 21, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1b, single center, dose-escalating study evaluating the safety, tolerability, and pharmacodynamic effect of RBT-3 in healthy volunteers and in subjects with stage 3-4 chronic kidney disease.

NCT ID: NCT04066140 Completed - Clinical trials for Kidney Failure, Chronic

Patient Activation in Dialysis

PAMD
Start date: June 17, 2019
Phase:
Study type: Observational

Patient activation refers to patients' willingness and ability to make independent actions to manage their health and care and requires knowledge, skill and confidence. This study aims to explore activation levels of incident dialysis patients at start of dialysis and after 3 months of dialysis.

NCT ID: NCT04016311 Completed - Quality of Life Clinical Trials

A Brief Mindful Drinking/Eating Intervention for Hemodialysis Patients With Fluid Restrictions

Start date: June 25, 2019
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to find out whether mindful drinking/eating activities can improve quality of life and help make it easier for people on dialysis to follow their fluid restrictions. The pilot study is a randomized controlled trial with an intervention group and a wait list control group, randomized by cohort days. The intervention occurs during dialysis sessions once a week for 4 weeks. During each intervention session, participants are guided through a mindful eating exercise focused on foods recommended for controlling thirst (e.g., hard candy, frozen grapes) and a mindful drinking exercise. Participants are asked to practice mindful drinking/eating at least once daily at home.

NCT ID: NCT03988270 Completed - Kidney Failure Clinical Trials

Prefistula Forearm Exercise in Pts Requiring Chronic HD Therapy

Start date: June 17, 2019
Phase: N/A
Study type: Interventional

For chronic hemodialysis patients, the creation of a well-functioning arteriovenous (AV) fistula is critical for ensuring that patient receive adequate hemodialysis. Unfortunately, the primary failure rate for AV fistulas after surgery is about 40%, and this percentage has not changed despite a number of trials of pharmaceutical agents and biologic agents. A key to success in the development of a useable AV fistula is an adequate arterial and venous diameter in the access forearm. Although exercise is commonly used to increase vessel diameter after AV fistula placement, Investigators are unaware of published studies that report on the effect of exercise prior to AV fistula placement to assist with the maturation of a newly created AV fistula. In this pilot trial, the Principal Investigator will evaluate the feasibility and possible benefits of pre-surgical exercise on forearm AV fistulas.

NCT ID: NCT03980795 Completed - Clinical trials for Kidney Failure, Chronic

Exercise in Peritoneal Dialysis Patients (PDEX)

PDEX
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Patients with end-stage kidney disease (ESKD) receiving peritoneal dialysis (PD) are physically inactive, resulting in poor physical function and reduced quality of life. The aim of this pilot trial was to test the study feasibility of a combined resistance and cardiovascular exercise program (recruitment and retention rates) and report adherence and adverse events. The intervention (I) group received monthly exercise physiologist consultations, exercise prescription (resistance and aerobic exercise program using exercise bands) and weekly phone calls over 12 weeks. Control (C) group received normal care. Feasibility outcomes were exercise adherence rates and adverse events. Secondary measures included physical function measures and patient-reported outcome measures (PROMs)

NCT ID: NCT03925454 Completed - Kidney Failure Clinical Trials

FREquent DIalysis & Markers of Cardiac Strain and Injury, Physical Fitness, Habitual Physical Activity & Quality of Life

FREDI-CAL
Start date: March 19, 2019
Phase:
Study type: Observational

Individuals with kidney failure are kept alive using dialysis machines designed to remove toxic substances and excess fluid from the blood. Standard dialysis is undertaken three times a week at a dialysis unit, supported by a team of specialist dialysis nurses (so called in-centre haemodiafiltration or ICHDF). Each session lasts approximately 4 hours, during which time the fluid and toxins which have built up since the last session of treatment are removed from the blood. The rapid removal of fluid that takes place using this technique often causes unpleasant symptoms such as cramps and dizziness, as well as a "hangover", which may last several hours. It can also cause problems with the heart in the long-term. In recent years, individuals requiring dialysis have been able to choose between standard ICHDF or having haemodialysis at home (HHD) using a convenient table top machine called NxStage System One. This device is used more frequently than in ICHDF and for shorter sessions. As a result, the amount of fluid removed during each session is less than with ICHDF. This may be beneficial to the heart, but may also make these individuals feel generally better, which may make them want to be more physically active. It may also reduce the time taken to recover from any symptoms experienced after dialysis. Over a 12 month period, markers of heart damage (using blood tests and scans of the heart) in patients receiving frequent HHD will be studied and the results will be compared with a group of patients receiving ICHDF. The study will also compare any symptoms they may have, how fit they are, how physically active they are and how well they sleep. In addition, the investigators will assess how well fluid balance is maintained in each group and measure the changes in their remaining kidney function during this time.

NCT ID: NCT03909698 Completed - Hemodialysis Clinical Trials

Antibiotic Dosing in Patients on Intermittent Hemodialysis

Start date: September 15, 2016
Phase:
Study type: Observational

The adequacy of the currently used dosing regimen of glycopeptides (vancomycin and teicoplanin) and beta-lactam antibiotics (amoxicillin-clavulanic acid, piperacillin-tazobactam, ceftazidim) in patients with end-stage kidney disease receiving intermittent hemodialysis is studied by evaluating pharmacokinetics-pharmacodynamics (PK-PD) target attainment. A population pharmacokinetic study is performed to assist the selection of the optimal individualized dose for patients undergoing intermittent dialysis, taking into consideration as many relevant variables as possible.

NCT ID: NCT03883698 Completed - Hepatitis C Clinical Trials

Safety of Sofosbuvir in People With Advanced Kidney Failure

Start date: March 15, 2019
Phase: Phase 3
Study type: Interventional

Infection with hepatitis C virus (HCV), a hepatotropic RNA virus, is often chronic, and causes liver cirrhosis and liver cancer. The virus is transmitted through parenteral exposure. This infection is particularly common in those on maintenance hemodialysis. Sofosbuvir, an inhibitor of HCV RNA-dependent RNA polymerase, forms the backbone of DAA-based anti-HCV treatment regimens. In pre-clinical pharmacokinetic studies, administration of the usual 400 mg daily dose to in presence of advanced kidney failure (estimated glomerular filtration rate [eGFR] of <30 ml/min) showed that serum levels of the sofosbuvir and GS-331007, the primary metabolite of sofosbuvir, were elevated by several folds. Hence, sofosbuvir is not approved for use in people on maintenance hemodialysis. The newer DAAs (e.g. grazoprevir/elbasvir combination), which have been approved for use in people with eGFR <30 ml/min, are very costly and are not available in Asian countries including India. Hence, as a rescue measures, several physicians, including our group, have tried half-daily dose (i.e, 200 mg daily or 400mg on alternate days) of sofosbuvir and 60 mg daclatasvir in dialysis-dependent people, with good results in terms of both safety and efficacy. In fact, the use of this empirical 200 mg daily dose schedule has become common in clinical practice. However, this use is not based on any pharmacokinetic data. Hence, it is proposed to study the pharmacokinetics of low-dose (200 mg daily or 400 mg alternate day) of sofosbuvir and GS-331007 metabolite in people with eGFR <30/min and active HCV infection.

NCT ID: NCT03873038 Completed - Clinical trials for Kidney Failure, Chronic

Safety and Pharmacokinetics of MK-2060 in Older Participants With End-Stage Renal Disease on Hemodialysis (MK-2060-004)

Start date: April 29, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2060 after intravenous (IV) administration of single and multiple doses in older adult participants with end-stage renal disease (ESRD) on hemodialysis (HD).

NCT ID: NCT03836508 Completed - Clinical trials for Renal Insufficiency, Chronic

Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Double blinded, randomized controlled trial evaluating medium cut-off dialyzer compared to high flux dialyzer in ironic hemodialysis patients over a 6 months period with 3 months crossovers.