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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT05387187 Enrolling by invitation - Clinical trials for Chronic Kidney Diseases

Evaluate the Effect and Safety of Pu Yang Wan Wu Tang and Western Medicine on Chronic Kidney Disease

Start date: May 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The indication of Pu Yang Wan Wu Tang is stroke sequelae, such as half body paralysis, aphasia and muscle weakness. Pu Yang Wan Wu Tang is proved to have the effect of protecting nerve and blood vessel, anti-inflammation, anti-coagulation, dilating peripheral vessel, promot-ing micro circulation, improving hemodynamics, and activating central nerve system. Huangqi could attenuate podocyte injury by regulating the expression and distribu-tion of nephrin and podocin. Huangqi and Danggui are associated with fewer infiltra-tion of macrophages and limitation of renal intrinsic cell activation, which may lead to earlier and persistent reduction of proteinuria. This research will use the compound Chinese medicine, Pu Yang Wan Wu Tang. Those treatments combined Western medicine to assess the efficacy and drug safety on the CKD cases. Series of blood and urine were collected regularly during study to prove the role of Chinese medicine in the treatment of CKD, and to assess their drug safety. The final goal of the plan is to establish the new indication of Pu Yang Wan Wu Tang and enhance the interaction and cooperation between Chinese and Western medicine.

NCT ID: NCT05374291 Enrolling by invitation - Heart Failure Clinical Trials

The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD

Start date: November 8, 2022
Phase: Phase 3
Study type: Interventional

Rationale: Sodium glucose co transporter 2 (SGLT2) inhibitors are a relatively new class of agents, originally developed as oral antihyperglycemic drugs. SGLT2 inhibitors are clinically available since 2012 for the treatment of patients with diabetes mellitus type 2. Later, SGLT2 inhibitors appeared to have also specific reno- and cardioprotective effects. Remarkably, the trials that have been performed thus far excluded patients with an eGFR below 25 mL/min/1.73m2 at inclusion, prevalent dialysis patients, and kidney transplant recipients. This is unfortunate, because especially these patients are at high risk of reaching kidney failure requiring dialysis, cardiovascular complications and mortality, whereas there are only few proven effective therapies. There is emerging evidence from experimental studies and post hoc-analyses of randomized clinical trials that SGLT2 inhibitors may also be effective in preventing cardiovascular and mortality outcomes in these patients with severe CKD, including patients receiving dialysis or living with a kidney transplant. For instance, subgroup analysis of the DAPA-CKD trial comparing 624 patients with an eGFR<30 to the remainder of the trial population with better kidney function, demonstrated that the efficacy of the SGLT2 inhibitor dapagliflozin in reducing cardiovascular, heart failure and renal outcomes persisted in the population with impaired kidney function. Furthermore, in the DAPA-CKD trial patients continued to use dapagliflozin or placebo when dialysis was initiated. In the subgroup of patients who initiated dialysis, dapagliflozin was associated with a relative risk reduction for mortality of 21%. Finally, in kidney transplant recipients, SGLT2 inhibitors have been shown to be effective in lowering HbA1c, body weight, blood pressure and stabilize kidney function, and these agents were well tolerated and safe. Taken these findings together there is a sound rationale to study the long-term reno- and cardioprotective efficacy and safety of SGLT2 inhibitors in patients with severe CKD. There are two cardiac sub-studies: the cardiac MRI substudy and the echocardiography sub-study. The echocardiography sub-study is referred to as the "SGLT-2-inhibitors to Target Heart Failure in Peritoneal Dialysis" (STOP HF in PD) study. In STOP HF in PD the effect of dapagliflozin on cardiac function will be assessed in a subset of 100 patients treated with peritoneal dialysis.

NCT ID: NCT05359094 Enrolling by invitation - Clinical trials for Chronic Kidney Disease

Probiotic Supplements in Chronic Kidney Disease

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

This research will investigate the effect of oral probiotic supplements on renal function, uremic toxins inflammatory response, nutrition status, gastrointestinal symptoms, and QoL with Chronic kidney disease.

NCT ID: NCT05284656 Enrolling by invitation - Clinical trials for Chronic Kidney Diseases

Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease

Start date: January 8, 2022
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the effect of administration of folic acid and /or pentoxifylline on patients with chronic kidney disease (CKD).

NCT ID: NCT05279742 Enrolling by invitation - Clinical trials for Chronic Kidney Diseases

Enhancing the Natriuretic Peptide System in HFpEF

Start date: November 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to look at the differences in how individuals with heart failure with preserved ejection fraction in the presence of chronic kidney disease (HFpEF-CKD) and exercise induced dyspnea without objective findings of fluid retention (HFpEF-EI) bodies function using drugs Sacubatril/Valsartan (Entresto) and MANP.

NCT ID: NCT05273424 Enrolling by invitation - Clinical trials for Chronic Kidney Diseases

Clinical Outcomes of Hemodialysis in Brazil (COHEBRA): a Prospective Cohort Study

COHEBRA
Start date: June 1, 2017
Phase:
Study type: Observational

Introduction: Chronic kidney disease (CKD) is characterized by progressive decrease in glomerular filtration rate (GFR), eventually reaching the end-stage renal disease (ESRD) requiring renal replacement therapy (RRT). The decrease in GFR is associated with a linear increase in cardiovascular mortality. Dysfunction of the autonomic nervous system (ANS) has been well documented in patients with CKD, especially in people with ESRD. The renal ischemia causes both the excessive activation of the renin-angiotensin-aldosterone system (RAAS) by increasing renin release, as sympathetic ANS, through the afferent sympathetic nerves. The overactivated RAAS and sympathetic SNA feedback each other, which contributes to cardiovascular disease (CVD) in CKD. Despite the involvement of these systems in the pathogenesis of CVD in CKD, drugs that block the RAAS or sympathetic SNA have shown heterogeneous effects in CVD in this population. A potential explanation is the genetic heterogeneity, such as the polymorphism in the gene for angiotensin converting enzyme (ACE).In addition, the inflammatory process associated with CKD is regarded as central player in the general degenerative changes backing CKD on HD shorter survival, which in many aspects is like accelerated aging. Skeletal muscles are also affected in a pattern like aging sarcopenia, with loss of function and mass. Objectives: to evaluate the impact of ECA gene polymorphism, HRV, body composition, functional capacity, muscle strength, inflammatory factors and other potential predictors on the survival of patients with CKD treated by HD in a single center in southern Brazil. Methodology: Prospective cohort study. The sample will consist of adult patients with CKD on HD longer than 90 days. Sociodemographic and clinical data is collected from clinical records. HRV analysis is performed using a Micromed@ electrocardiogram device® with a recording of the standard deviation of all normal intervals (SDNN), square root of the mean of the squares of the differences between consecutive intervals (RMSSD), low frequency band (LF) and high frequency (HF) after a midweek HD session. The polymorphism of the ECA gene was evaluated by polymerase chain reaction method in peripheral blood DNA sample. Muscle quality and thickness has been obtained by ultrasound. Functional capacity by 6-minute walking test and muscle strength by dynamometer. The data will be analyzed using Stata 15.0 statistical package.

NCT ID: NCT05227313 Enrolling by invitation - Clinical trials for Chronic Kidney Diseases

Double-Blind, Placebo-Controlled Trial of Eefooton in Patients With Chronic Kidney Disease

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

This phase II study, 24-week, double-blind, study evaluated Eefooton's safety and efficacy for patients with CKD stage 3 to 4 Not on dialysis.

NCT ID: NCT05169411 Enrolling by invitation - Clinical trials for Pediatric Kidney Disease

Preserving Kidney Function in Children With Chronic Kidney Disease

PRESERVE
Start date: September 22, 2023
Phase: N/A
Study type: Interventional

Pediatric chronic kidney disease (CKD) results from health conditions that reduce kidney function for >3 months. It can progress to end-stage kidney disease (ESKD), which requires dialysis or kidney transplant. In adults, CKD is common and caused mainly by hypertension and diabetes. CKD in childhood is rare and caused primarily by congenital anomalies of the genitourinary system and immune-mediated disorders. The best estimate of pediatric CKD prevalence is <1/15,000 pediatric population. Hypertension occurs in 50% of affected children and is a major risk factor for decline in kidney function. Several clinical practice guidelines have offered recommendations for blood pressure (BP) management in pediatric CKD; however, clinical trial and large-scale observational data are limited, leading to a weak evidence base and substantial practice variation. The purpose of PRESERVE is to provide new knowledge to inform shared decision-making regarding BP management for pediatric CKD. We will leverage the Patient-Centered Outcomes Research network (PCORnet®) infrastructure to conduct large-scale observational studies that will address BP management knowledge gaps for pediatric CKD and sub-groups for whom antihypertensive treatment and outcome associations may be different (e.g., cause of kidney disease and proteinuria). The project's specific aims are: Aim 1-Enhance the PCORnet Common Data Model (CDM) for pediatric and rare kidney disease research. We will expand and improve the PCORnet CDM with new pediatric- and kidney-specific variables, study-specific data quality optimization, and linkage with the chronic kidney disease in children (CKiD) cohort study and the US Renal Data System (USRDS). CKiD directly measures kidney function [ie, glomerular filtration rate (GFR)] and includes Ambulatory Blood Pressure Monitoring (ABPM). The USRDS provides complete capture of renal replacement therapy [(RRT) dialysis and transplant], two components of the primary clinical outcome. Aim 2-Describe and examine the effectiveness of consistent BP and urine protein monitoring for preserving kidney function. We will describe the consistency of BP and urine protein monitoring and will contrast clinic BP assessments with ABPM. In longitudinal analyses, we will evaluate the effects of consistent monitoring of BP and urine protein on kidney function decline. Aim 3-Compare the effectiveness of BP medication strategies for preserving kidney function. We will compare the effects of (1) BP levels when treatment was started, (2) choice of first-line therapies, and (3) ongoing BP control on kidney function decline. We will also assess adverse events related to hypertension management. Aim 4-Assess patients' lived experiences related to BP management. We will field a survey that examines patient-centered outcomes by level of BP control and medication management approaches. This Aim will provide information on experiences with BP management from the perspectives of patients, parents, and clinicians that will complement the clinical outcomes studied in Aims 2 and 3.

NCT ID: NCT05161078 Enrolling by invitation - Acute Kidney Injury Clinical Trials

ICONIC: Improving Carpediem Outcomes in Neonates and Infants Through Collaboration

ICONIC
Start date: December 16, 2021
Phase:
Study type: Observational [Patient Registry]

To date, little knowledge exists related to the use of hemodialysis (HD) in infants and has been limited to mainly single center studies. The CARPEDIEM (CArdio-Renal PEdiatric Dialysis Emergency Machine) device, which can be used to provide hemodialysis in infants, has been launched in the United States. This study/registry is designed to obtain data on critically ill infants who require HD using the CARPEDIEM device to understand the indications for initiation, best practice in prescribing and performing treatment, expected treatment course, and outcomes of a dedicated infant continuous renal replacement therapy (CRRT) machine.

NCT ID: NCT05086185 Enrolling by invitation - Hyperkalemia Clinical Trials

Effect of Viscous Fiber on Postprandial Kalemic Response in Hemodialysis Patients

Start date: June 29, 2021
Phase:
Study type: Observational

High blood potassium levels (hyperkalemia) is a major problem for people with kidney failure undergoing hemodialysis treatment. In order to reduce the risk of hyperkalemia, people with kidney failure are advised to limit or avoid high-potassium foods. However, high-potassium foods comprise many healthy food choices, including commonly consumed fruits and vegetables that are key sources of dietary fiber, and other important nutrients. Risk of hyperkalemia from dietary potassium intake is most notable in the first few hours after a meal when ingested potassium enters the bloodstream. In general, dietary potassium is very well absorbed. However, dietary fiber has been shown to increase the proportion of dietary potassium that is excreted in stool. Based on these findings, it has been proposed that fiber may help to lower the risk of hyperkalemia in people with kidney disease. It remains unclear whether dietary fiber increases potassium excretion in stool by reducing the absorption of dietary potassium, or by drawing body potassium into the bowels by increasing stool bulk. The distinction may be important, as reducing potassium absorption would be expected to be of greater benefit in preventing hyperkalemia caused by eating high-potassium foods. In this study, the investigators will assess whether a fiber supplement can reduce the effect of dietary potassium from orange juice on blood potassium levels in people with kidney disease undergoing maintenance hemodialysis treatment.