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Peritoneal Dialysis Complication clinical trials

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NCT ID: NCT06398977 Recruiting - Clinical trials for Peritoneal Dialysis Complication

Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients

Start date: March 11, 2024
Phase: N/A
Study type: Interventional

This study aims to explore the role of dagliflozin in preserving the residual renal function(RRF) in peritoneal dialysis (PD) patients.

NCT ID: NCT06350552 Recruiting - Clinical trials for End Stage Renal Disease

Prevalence of Postural Abnormalities in Dialysis Patients

Start date: April 28, 2024
Phase:
Study type: Observational

The goal of this observational study is to investigate and compare the prevalence of forward head , hyper kyphosis and balance in hemodialysis and peritoneal dialysis patients. The main questions it mains to answer are: What is the prevalence of forward head posture in hemodialysis and peritoneal dialysis patients? What is the prevalence of hyper kyphosis in hemodialysis and peritoneal dialysis patients? Is there any relation between postural abnormalities and physical function in hemodialysis and peritoneal dialysis patients? Participants will answer 2 questionnaires and will do some functional tests.

NCT ID: NCT06119373 Not yet recruiting - Survival Clinical Trials

Incremental PD With Single Icodextrin Exchange

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Objectives: To investigate the efficacy and safety of single daily icodextrin exchange for initiation of incremental peritoneal dialysis (PD). Subjects: Seventy-two incident PD patients. Methods: A single-center randomized controlled trial. Primary outcome: Change in residual kidney function in 48 weeks after recruitment.

NCT ID: NCT06045858 Not yet recruiting - Atrial Fibrillation Clinical Trials

SAFETY AND EFFICACY OF APIXABAN VERSUS WARFARIN IN PERITONEAL DIALYSIS PATIENTS WITH NON VALVULAR ATRIAL FIBRILLATION: A PROSPECTIVE, RANDOMISED, OPEN-LABEL, BLINDED END-POINT TRIAL (APIDP2)

APIDP2
Start date: June 30, 2024
Phase: Phase 3
Study type: Interventional

Introduction: Several randomised controlled trials have demonstrated that novel oral anticoagulants (NOACs) are safer compared to vitamin K antagonists for the management of non valvular atrial fibrillation (NVAF) to prevent thromboembolic events, in the general population. There is a growing interest in the use of apixaban in patients with End-Stage Renal-Disease (ESRD) undergoing peritoneal dialysis but there is a lack of randomised data in this population. Design: APIDP2 is a prospective parallel randomised, open-label, blinded endpoint trial. Participants: Patients with ESRD undergoing chronic Peritoneal Dialysis who have NVAF. Setting: A total of 178 participants will be recruited from 20 French peritoneal dialysis centers. Intervention: Eligible patients will be randomly assigned to receive either apixaban at a reduced dose 2.5mg twice daily (dose determined with the previous pharmacokinetic study APIDP1 of apixaban in PD patients) or dose-adjusted to INR target [2-3] coumadin therapy. Anticoagulation to prevent thromboembolic events will be initiated or changed according to the randomisation for a duration of one year. The primary outcome is a major or clinically relevant non-major bleeding from randomisation up to Month 12, assessed according to ISTH score. Secondary outcomes encompass an efficacy composite criterion combining stroke or TIA, cardiovascular death, and thrombosis including myocardial infarction cumulated at 12 months. Bleeding events will be also classified according to GUSTO and TIMI criteria and pharmacodynamics outcomes will evaluate the time within the INR target range of [2-3] in the warfarin arm over one year, and AntiXa apixaban activity in case of bleeding events and at 1, 6, and 12 months of follow-up in the apixaban arm. Primary outcome analysis: To demonstrate that apixaban is safer than warfarin at one year, assuming two interim analyses after 60 and 118 patients, a bilateral alpha risk of 5% and a power of 80%, 178 patients are needed in this randomised trial (effect size found in the ARISTOTLE study among patients with CrCl [25-30]ml/min), i.e. 89 patients per group.

NCT ID: NCT05797181 Completed - Sarcopenic Obesity Clinical Trials

The Effect Of Medical Nutritional Therapy On Patients With Sarcopenic Obesity Receiving Peritoneal Dialysis Treatment

Start date: February 7, 2023
Phase: N/A
Study type: Interventional

In this study, it was aimed to evaluate the effectiveness of medical nutrition therapy to be applied to patients with sarcopenic obesity receiving peritoneal dialysis treatment by measuring anthropometric measurements and blood parameters.

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: NCT05250752 Enrolling by invitation - Clinical trials for End Stage Renal Disease

Reduction of Peritoneal Glucose Uptake With Use of SGLT2 in Humans Undergoing Peritoneal Dialysis Treatment

PRESERVE
Start date: November 18, 2021
Phase: Phase 2
Study type: Interventional

End stage renal disease is annually diagnosed in about one thousand patients in Denmark, and one of the treatment modalities in renal replacement therapy is peritoneal dialysis with about 25 % of patients assigned to this treatment (Hommel2010). Peritoneal dialysis is based on the principle of filtering waste products to peritoneal fluid and by exchange of peritoneal fluid eliminate waste products from the body. In peritoneal dialysis commonly used fluids contain glucose. Exposure to high glucose levels in peritoneal fluid during peritoneal dialysis has several side effects. Primarily, as glucose passes over and into the peritoneal membrane it causes local inflammation which leads to fibrosis over time (Zhou2016). Fibrosis limits the capacity of the exchange of water and waste products over the peritoneal membrane. The decrease of peritoneal exchange capacity is most commonly the reason for termination of peritoneal dialysis. SGLT2-channels are identified in peritoneal mesothelial cells of rats (Debray-Carcia 2016), and most recently also in humans (Shentu2021). An in vitro model of human peritoneal mesothelial cells incubated with the SGLT2-inhibitor (empagliflozin) has shown significantly decrease in glucose uptake (Zhou2019). Exposure to intraperitoneal empagliflozin in rats, reduced the uptake of glucose over the peritoneal membrane significantly by 78 % and the ultrafiltration was increased (Zhou2019). Currently, to our knowledge, no clinical trials have been conducted in humans attending peritoneal dialysis with the aim of investigating either the effect or safety of SGLT2i, as it is indeed the first of its kind, with the aim of including participants in peritoneal dialysis.

NCT ID: NCT05224466 Not yet recruiting - Clinical trials for Peritoneal Dialysis Complication

Characteristics and Clinical Outcomes of Peritoneal Dialysis Patients

Start date: March 2022
Phase:
Study type: Observational

Peritoneal dialysis patients worldwide account for about 11% of the global dialysis population. The global annual growth rate of peritoneal dialysis is estimated to be 8%, which is listed as the preferred method of renal replacement therapy in most countries. Although peritoneal dialysis has been widely used, due to complications such as peritoneal dialysis related infection, peritoneal ultrafiltration failure and EPS, the failure rate of peritoneal dialysis technology is high, and the 3-year technical survival rate is only 64%. Therefore, this study intends to explore clinical strategies for maintaining the long-term peritoneal dialysis by analyzing the clinical characteristics of patients , as well as the differences of risk factors affecting the survival rate of peritoneal dialysis technology at different time stages of peritoneal dialysis treatment.

NCT ID: NCT04923295 Completed - Clinical trials for Peritoneal Dialysis Complication

The Effect of Dapagliflozin on Ultrafiltration Among Peritoneal Dialysis Patients

Start date: June 2, 2021
Phase: N/A
Study type: Interventional

Patients with average or high average peritoneal glucose transport status be included in the study as mentioned in the inclusion and exclusion criteria. The change in peritoneal glucose transport will be evaluated before and after one month treatment with 10 mg of Dapagliflozin. Peritoneal Equilibration Test (PET) test for patients before and after Dapagliflozin use and volume status of patients as measured by ultrafiltration from peritoneal dialysis exchanges. The aim of the trial is to determine whether dapagliflozin can decrease glucose absorption from peritoneal fluid and reduce plasma glucose absorption from the PD fluid and thus improve ultrafiltration with a reduction in intraperitoneal glucose exposure

NCT ID: NCT04797195 Completed - Clinical trials for Kidney Failure, Chronic

Improving Care for Peritoneal Dialysis Patients With the CKD-PD App

Start date: December 13, 2021
Phase: N/A
Study type: Interventional

Managing the hydration status in patients undergoing peritoneal dialysis (PD) is a key task for nephrologists in Thailand that is made difficult due to lack of timely access to hydration metrics including weight, blood pressure, and ultrafiltration volume. This research project aims to improve the monitoring of hydration status in PD patients from a bimonthly, in-clinic review of a handwritten log-book to a smart phone based app (CKD-PD) with digitized data that allows for near real time monitoring hydration abnormalities, thereby creating the opportunity for earlier treatment of overhydration. The investigators hypothesize that use of the CKD-PD will improve early treatment of overhydration, and potentially reduce the incidence of complications, hospitalizations, and mortality in PD patients.