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Chronic Kidney Diseases clinical trials

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NCT ID: NCT06112821 Recruiting - Clinical trials for Chronic Kidney Diseases

Arteriovenous Fistula Maturation in Hemodialysis Patients With or Without Positive Antiphospholipid Antibodies

Start date: July 1, 2022
Phase:
Study type: Observational

Hemodialysis (HD) is one of the most often used modalities of blood epuration in ends-stage renal diseases (ESRD) and requires the creation of a patent vascular access such as an arteriovenous fistula (AVF). Native AVF is associated with lower morbidity and mortality compared to hemocatheters. AVF need a maturation process before its use. This process usually requires less than 6 weeks and consists in a complex vascular remodeling process. Maturation can be considered as the process leading to a newly created AVF being usable for hemodialysis; it encompasses enlargement and thickening of the draining fistula vein, increasing the blood flow in the absence of thrombosis and bleeding. According to the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, AVF is considered matured (and therefore usable for HD) if 6 weeks after AVF creation surgery: (a) its diameter is at least 6mm, (b) its depth less than 6mm, (c) flow rate is at least 600ml/min and (d) its length is at least 6cm in order to allow a two needles cannulation. Delayed AVF maturation is a major complication that affects more than half of the AVF. It can be defined as the delay or absence of maturation according to KDOQI guidelines. The pathophysiology of delay or absence of AVF maturation is complex and multifactorial. It mainly involves thrombosis, stenosis, endothelial dysfunction, and hypercoagulability states. In order to promote AVF maturation, the 2019 ERA-EDTA Clinical practice guidelines on peri- and postoperative care of native AVF and grafts for HD in adults, propose some medical treatments. Antiphospholipid syndrome (APS) is an autoimmune disease, characterized by a prothrombotic state affecting both arterial and venous vasculature. Classification criteria have been proposed in 2006. In HD patient, up to 37% of patients have persistent aPL positivity. aPL positivity has been associated with vascular access thrombosis in retrospective studies. The investigators performed a retrospective analysis of 113 patients in the HD department of the Brugmann Hospital between 01/01/2019 and 01/08/2019. Unpublished data that are currently under evaluation for publication, showed that the prevalence of APS and antiphospholipid antibody positivity (aPL) without APS, was 18.5% and the prevalence of APS was 10.7%. Antiphospholipid antibody positivity was identified as a risk factor for delayed AVF maturation. In multivariate analysis, antiphospholipid antibody positivity and stenosis were both independent risk factors for delayed maturation. There is a statistically significant association between delayed native AVF maturation and antiphospholipid antibody positivity. This association was independent of arteriovenous stenosis. This data suggest a potential non-stenotic and/or non-thrombotic mechanism of aPL related delayed maturation of the AVF in HD patients. More interestingly, a significant association between aPL positivity (with or without antiphospholipid syndrome) and delayed AVF maturation was found. This association was independent of stenosis. Considering this association between aPL and failure of native AVF maturation, the aim of the present study is to further evaluate this association in a prospective cohort and to further identify a potential treatment option in order to reduce the prevalence of this very common complication '(i.e. AVF delay or absence of maturation).

NCT ID: NCT06110130 Recruiting - Clinical trials for Chronic Kidney Diseases

Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD

NDKD
Start date: February 2, 2024
Phase: Phase 4
Study type: Interventional

Primary Objective:To study podocyte specific injury markers in African American Veterans with non-diabetic kidney disease(NDKD), on empagliflozin therapy. Primary Endpoint: Assess the effect of Empagliflozin on podocyte-specific proteins in exosomes isolated from subjects' urine, such as nephrin, podocalyxin and Wilms'Tumor (WT-1) protein. Secondary Objective: 1. Correlate changes in exosome-based podocyte specific proteins with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR. 2. Correlate systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12) , hs-CRP and arterial stiffness measures with urine exosome-based podocyte protein estimation. 3. Correlate urine podocyte-specific protein markers with APOL1 mRNA expression levels in blood mononuclear cells (MNC)

NCT ID: NCT06109493 Recruiting - Depression Clinical Trials

Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease

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

Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of patients with chronic kidney disease.

NCT ID: NCT06094231 Recruiting - Diabetes Mellitus Clinical Trials

Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study

Start date: September 25, 2023
Phase: N/A
Study type: Interventional

This randomized controlled trail will evaluate the efficacy and safety of a simultaneous therapeutic carbohydrate restriction and treatment with the Sodium-Glucose-Transporter-2-Inhibitor dapagliflozin in comparison to the standard of care treatment in patients with chronic kidney disease and prediabetes or type 2 diabetes mellitus. Participants will be randomized 1:1. The interventional group will be educated on how to implement a therapeutic carbohydrate restriction (50-100 grams of carbohydrates per day). Regarding safety, the patients of the interventional group will be provided with continuous glucose monitoring systems and blood ketone meters. The participants of the control group will continue to receive the standard of care therapy for the treatment of chronic kidney disease and prediabetes or type 2 diabetes mellitus. Both groups will be treated with dapagliflozin.

NCT ID: NCT06071143 Recruiting - Clinical trials for Chronic Kidney Diseases

Safety and Efficacy of KDSTEM Inj. in Patients With Chronic Kidney Disease

Start date: February 29, 2024
Phase: Phase 1
Study type: Interventional

A Single arm, Open-labelled, Dose-escalation, Single-center, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Autologous Urine-derived Stem Cells, 『KDSTEM Inj.』, in Patients with Chronic Kidney Disease. The aim of this study is to evaluate the safety and preliminary efficacy of KDSTEM Inj. in the treatment in Patients with Chronic Kidney Disease.

NCT ID: NCT06056245 Recruiting - Clinical trials for Chronic Kidney Diseases

Methadone Pharmacokinetics in End-stage Renal Disease

MCKD
Start date: April 5, 2024
Phase:
Study type: Observational

The goal of this observational study is to describe the influence of renal function on the pharmacokinetics of methadone used through an intravenous patient-controlled analgesia (IV-PCA) pump for the management of acute postoperative pain. After surgery the participants will use an IV-PCA of methadone and blood samples will be withdrawn to measure the plasmatic levels of it. The main question the study aims to answer is: • Is the pharmacokinetic of methadone used in an IV-PCA pump impaired in patients with chronic kidney disease?

NCT ID: NCT06019871 Recruiting - Clinical trials for Chronic Kidney Diseases

The Danish Symptomburden Study Among Patients With Advanced Kidney Disease

Start date: March 15, 2023
Phase:
Study type: Observational

Patients with chronic kidney disease stage five have a high symptom burden regardless of whether they are treated with dialysis or without dialysis, a conservative kidney management pathway (CKM). Previously, there has not been a validated tool in Danish to collect information about symptoms. The Integrated Palliative Outcome Scale Renal (IPOS-Renal) has now been validated and translated into Danish. IPOS-Renal aims to identify symptoms among patients with chronic kidney disease stage five. The purpose of the study is to investigate whether there is a correlation between treatment - dialysis (haemodialysis or peritoneal dialysis) or CKM for patients >75 years of age with chronic kidney disease stage V and their symptom burden measured with IPOS-Renal. In addition, it is investigated whether there is a correlation between treatment - dialysis or CKM for patients >75 years of age with chronic kidney disease stage V and their mortality. The study will be conducted as an observational prospective cohort study over a two-year period, and based on a power calculation, it is expected to include 341 patients with data originating from 11 hospitals in Denmark. Comparison of change in symptom burden over time measured by IPOS-Renal for the two forms of treatment will be examined as continuous data, and then the t-test or Mann-Whitney test will be used. A cox proportional hazard regression analysis will be used to examine mortality for patients in dialysis treatment and patients on CKM pathway.

NCT ID: NCT06006819 Recruiting - Clinical trials for Chronic Kidney Diseases

Prognostic Markers of Acute Heart Failure With Chronic Kidney Disease

Start date: January 1, 2023
Phase:
Study type: Observational

Acute heart failure (AHF) is defined as new or worsening of symptoms and signs of heart failure and is the most frequent cause of unplanned hospital admission in elderly patients. N-terminal pro-brain natriuretic peptide (NT-pro-BNP) is one of the most developed prognostic markers for AHR patients and. NT-pro-BNP has limitations in terms of diagnostic or predictive accuracy in patients with chronic kidney disease (CKD). Plasma proteomics have the potential to examine underlying pathophysiological and prognostic roles, so we compared the plasma proteomic signature to predict outcomes of patients with or without CKD hospitalized for AHF.

NCT ID: NCT06001827 Recruiting - Clinical trials for Chronic Kidney Diseases

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

SAVE-FistulaS
Start date: November 20, 2023
Phase: N/A
Study type: Interventional

This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.

NCT ID: NCT05991089 Recruiting - Hypertension Clinical Trials

Tunisian Clinical Registry on Chronic Kidney Disease in Hypertensive Patients

TUN-CKDH
Start date: January 8, 2024
Phase:
Study type: Observational [Patient Registry]

In Tunisia, high blood pressure (HTN) is a public health problem whose prevalence varies from 28.7% to 34.7%. Hypertension can be both, cause and consequence of chronic kidney disease, and its prevalence is quite high in this population. It is both a risk factor for mortality and cardiovascular morbidity, but also a major cause of terminal chronic kidney disease becoming an additional public health concern. Detecting and diagnosing chronic kidney in all hypertensives at an early stage remains a global public health challenge. A well-conducted treatment makes it possible to reach the blood pressure objective but also to reduce the risk of occurrence of a cardiovascular event and to slow the progression of chronic kidney disease. In Tunisia, few data exists concerning the prevalence of chronic kidney disease in hypertensive subjects, thus limiting the development and elaboration of preventive measures. A national survey will thus be conducted by the "Kidney and Metabolic Diseases" Working Group under the aegis of the Tunisian Society of Nephrology, Dialysis and Kidney Transplantation. The main objective is to estimate the prevalence of chronic kidney disease in hypertensive tunisian patients.