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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT05189418 Recruiting - Clinical trials for Chronic Kidney Diseases

Sleep-time Blood Pressure and Risk of CKD Progression

SLEEP-BP-CKD
Start date: May 11, 2022
Phase:
Study type: Observational [Patient Registry]

The SLEEP-BP-CKD Study has been designed to specifically test the following primary hypotheses: (i) Specific ABPM-derived parameters, in particular the asleep SBP mean and/or the sleep-time relative SBP decline, are significant prognostic markers of deterioration of kidney function and progression towards ESKD, as well as of the risk of all-cause mortality and major CVD events, in high-risk patients with stage G3b-G4 CKD. (ii) Changes during follow-up in specific ABPM-derived parameters, in particular the increase of the asleep SBP mean and/or decrease of the sleep-time relative SBP decline towards the non-dipper/riser 24h SBP pattern, are significant prognostic markers of deterioration of kidney function and progression towards ESKD, as well as of the risk of all-cause mortality and major CVD events, in high-risk patients with stage G3b-G4 CKD. A novelty of the SLEEP-BP-CKD Study is the incorporation of clinical-grade wearable digital technology to monitor both wake-time and sleep-time BP at home in a subgroup (up to 200) of the total sample; this procedure will provide added useful information to test the following additional hypotheses: (iii) The HBPM self-assessment procedure to obtain BP measurements both during wake-time and sleep-time spans provides reliable data to be used either individually or jointly with periodic ABPM as added potential prognostic marker of deterioration of kidney function and progression towards ESKD, as well as of the risk of all-cause mortality and major CVD events, in high-risk patients with stage G3b-G4 CKD. (iv) The sleep-time BP measurements obtained by HBPM self-assessment and their changes during follow-up are better correlated, compared with wake-time OBPM or wake-time HBPM, to eGFR and albuminuria (measured by the albumin/creatinine ratio) and their changes during follow-up, respectively. (v) The HBPM self-assessment procedure to obtain BP measurements both during wake-time and sleep-time spans increases patient adherence/compliance to prescribed treatment from baseline. The scheduled periodic patient BP assessments during follow-up with OBPM, HBPM, 48h ABPM, along with laboratory urine and blood test data will further allow evaluating and comparing the changes from baseline in all these clinically relevant variables as potential markers for risk of progression towards ESKD, all-cause mortality, and/or CVD morbidity.

NCT ID: NCT05188885 Recruiting - Clinical trials for Chronic Kidney Disease

A Real World, Multi-centric, Observational Registry Study of Chronic Kidney Diseases

Start date: December 27, 2021
Phase:
Study type: Observational

Chronic kidney disease (CKD) refers to a variety of different diseases characterized by impairment of kidney structure and/or renal function. The prevalence of CKD in China is as high as 10.8%. With a population of more than 150 million, China has the largest number of CKD patients all over the world. People with CKD would not only progress to uremia and need renal replace treatment, it also significantly increases risk of cardiovascular disease than non-CKD population. It has created a heavy burden on people's health and national economy. There is an urgent need to establish an effective system for CKD prevention and control in China. Evidences from large sample cohort and real world based research are still rare. This study will provide good experience for reducing the occurrence and development of CKD.

NCT ID: NCT05183815 Not yet recruiting - Clinical trials for Fatigue; Hemodialysis; Chronic Kidney Disease; Quality of Life

Effectiveness of Slow Back Stroke Massage and Murrotal Quran on Fatigue and Quality of Life of Patients Undergoing Haemodialysis

EMQ
Start date: January 25, 2022
Phase: N/A
Study type: Interventional

The study aimed to investigate the effectiveness of slow back stroke massage and murrotal Quran on fatigue and quality of life on patients undergoing hemodialysis.

NCT ID: NCT05183737 Active, not recruiting - Inflammation Clinical Trials

Effects of Microencapsulated Propolis and Turmeric in Patients With Chronic Kidney Disease

Start date: March 7, 2022
Phase: N/A
Study type: Interventional

Oxidative stress and inflammation are correlated with Chronic Kidney Disease (CKD), in a way that they bring several harms to patients, including an increased risk of cardiovascular disease and mortality. Adjuvant therapeutic options such as bioactive compounds present in some foods seem to mitigate inflammation. Turmeric and propolis are foods that have compounds with antioxidant and anti-inflammatory capacity, as they promote the activation of nuclear erythroid transcription factor 2 (Nrf2 - responsible for the synthesis of antioxidant enzymes) and inhibit the activity of nuclear factor Kappa B (NF-κB - which increases the synthesis of inflammatory cytokines). This work aims to evaluate the effects of supplementation of associated propolis and turmeric microcapsules on inflammatory markers in patients with CKD undergoing hemodialysis (HD).

NCT ID: NCT05182840 Completed - Clinical trials for Kidney Disease, Chronic

A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease

Start date: January 11, 2022
Phase: Phase 2
Study type: Interventional

This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study. The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin. In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine. In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05180604 Completed - Clinical trials for Cardiovascular Diseases

The Application and Evaluation of eHealth Literacy (eHL) Concept

eHL
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

This study aims to explore the effectiveness of experience learning program of eHealth care to improve the chronic patients' eHL in engaging with the eHealth care system on the indicators on eHealth literacy, patient health engagement, e-Health usage status among Chronic disease patients included type 2 diabetes patients, Chronic kidney disease, and Cardiovascular Diseases.

NCT ID: NCT05179668 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

SGLT2 Inhibition in Hemodialysis

DAPA-HD
Start date: October 1, 2022
Phase: Phase 2
Study type: Interventional

The study is designed as a prospective randomized, controlled, double-blinded phase II trial to examine the effect of the SGLT2 inhibitor dapagliflozin, in comparison with placebo on cardiovascular outcome parameters in kidney failure patients undergoing replacement therapy with hemodialysis. The primary endpoint is the change (∆) in left ventricular mass indexed to body surface area (LVMi) from baseline to 6 months measured by cardiac magnetic resonance imaging. Null and alternative hypotheses: H0: There is no difference in the ∆ Left Ventricular Mass indexed to BSA after six months of treatment, comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo. H1: There is a difference in the ∆ Left Ventricular Mass indexed to BSA comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo.

NCT ID: NCT05176730 Completed - Clinical trials for Chronic Kidney Diseases

Mindfulness Meditation For Hemodialysis Patients

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Objective: This study aimed to examine the effects of mindfulness meditation on trait mindfulness, perceived stress, emotion regulation, and quality of life in end-stage renal disease patients undergoing hemodialysis. Method: An experimental repeated measures design was used among a sample of 74 end-stage renal disease patients undergoing hemodialysis at a dialysis center at Jahra hospital, Kuwait. The patients were randomly assigned to the experimental (n=37) and control groups (n=37). The experimental group participated in 30-minute mindfulness meditation sessions (three sessions a week for five weeks) held during their hemodialysis sessions. The dependent variables of both groups were measured at baseline, middle of intervention, and end of intervention using the Mindful Attention Awareness Scale (MAAS), Perceived Stress Scale (PSS), Emotion Regulation Questionnaire (ERQ), and Kidney Disease Quality of Life (KDQOL-36) questionnaire.

NCT ID: NCT05173714 Recruiting - Obesity Clinical Trials

Sit Less, Interact and Move More (SLIMM) 2 Study

Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

- Prolonged sitting (sedentary behavior) is a risk factor for decreased kidney function, obesity, diabetes and mortality. Prolonged sitting is associated with decreased kidney function and increased risk of diabetes, heart disease and death. - In a previous pilot study funded by NIH, it was shown that a Sit Less, Interact and Move More (SLIMM) intervention targeting sedentary behavior in people with kidney disease was able to decrease prolonged sitting but that effect was not sustained. - Therefore, the researchers are currently conducting a follow-up study named Sit Less, Interact and Move More (SLIMM) 2. - This NIH funded study is conducted at the University of Utah and Stanford University. - The purpose of this study is to see if guided resistance training (to improve muscle strength) and semaglutide (FDA approved diabetes and weight loss medication that might also improve physical function) can boost adherence to the SLIMM Intervention and reduce sedentary behavior.

NCT ID: NCT05171686 Recruiting - Hypertension Clinical Trials

Diuretics and Volume Overload in Early CKD

DOCK
Start date: February 1, 2023
Phase: Phase 4
Study type: Interventional

Almost 15% of Americans have chronic kidney disease (CKD), with an even higher rate in Veterans due to common risk factors such as high blood pressure and diabetes. People with CKD have a high risk of cardiovascular (CV) diseases, such as heart attacks, heart failure, and strokes. Extra fluid in the body, called volume overload, may lead to CV disease in people with CKD. It is unknown if volume overload develops in the earliest stages of CKD, when treating it with common, inexpensive medicines called diuretics may improve long-term CV outcomes. This study will lay important groundwork to answer this question in Veterans with early CKD by comparing two ways to measure volume overload and studying the change in common symptoms like fatigue and short-term CV function after treatment with diuretic medicines.