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165 active trials for Chronic Kidney Diseases

Chronic Kidney Disease (CKD) Platelet Study

This study evaluates how aspirin, clopidogrel and ticagrelor work in people with chronic kidney disease (CKD) compared to people with normal kidneys. In the first part of the study, half of CKD participants will be randomly assigned to ticagrelor and aspirin, while the other half will be assigned to clopidogrel and aspirin in a blinded fashion. The treatment duration will be two weeks. After recruiting CKD participants the investigator will recruit controls with normal kidney function that will receive only ticagrelor and aspirin for two weeks.

Start: November 2018

Shear Wave Elastography in Differentiating Acute or Chronic Kidney Disease

Chronic kidney disease is a common global public health issue and its prevalence increased year by year. Early diagnosis and intervention can prevent further complications and comorbidities of long-term dialysis, cardiovascular events and mortality as well as improve the patients' life quality. To differentiate acute from chronic kidney disease was crucial especially in the setting of crowded and high-risk emergency department. To diagnose acute or chronic kidney disease, physicians usually use blood sample test combined with image studies such as conventional sonography, CT and MRI. However, there was lots of limited factors. The patients may have no previous visit records, poor renal function to receive contrast medium, or critical clinical condition to undergo time-wasting exam. Although the conventional renal sonography is accessible and inexpensive, the judgement is subjective and provide little clinical information. Recent researches of shear wave elastography in evaluating renal parenchymal stiffness showed some correlation with nephropathy. In our study, aiming to facilitating clinical implication, the investigators will use swear-wave elastography combined with conventional renal sonography to benefit patients in diagnosis of acute or chronic kidney disease.

Start: February 2020

Concomitant Renal and Urinary Bladder Allograft Transplantation

The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.

Start: June 2021

Evolocumab In Advanced Chronic Kidney Disease Trial

110 individuals with stage 4-5 Chronic Kidney Disease (CKD) will be randomized to 1-year of blinded Evolocumab or placebo. Subjects will undergo evaluation of circulating lipids at baseline and end of study. A substudy including 50 subjects will assess myocardial rest and stress positron emission tomography (PET) at baseline and at 1-year.

Start: March 2021

Characteristics, Treatment, and Economic Burden of Patients With CVD,CKD or at High Cardiovascular Risk

The heavy disease burden is mainly due to diabetic complications. Diabetes is a major risk factor for cardiovascular disease (CVD) and chronic kidney disease (CKD).China has been the largest absolute disease burden of diabetes in the world recently1. Diabetic patients with established CVD or CKD are bringing growing pressure upon our nation's healthcare expenditure1. However, the characteristic profile of Chinese diabetic patients who has CVD, CKD or at high risk of CVD remains unclear thus is in urgent need for in-depth investigation.In current China, however, the information regarding diabetes or non-diabetes patients who also had other comorbid conditions (e.g. established CV diseases, CKD or at high risk for such problem), is limited; the patient characteristics, treatment patterns and economic burden may not be fully understood.Therefore, based on TianJin regional database, the investigators will describe the demographic, clinical characteristics, treatment, and economic burden of disease of Chinese diabetic/non-diabetic patients with/without established CV disease, CKD, or at high CV risk including hypertension and hyperlipidaemia. And the investigators believe that the resulting findings will inform a comprehensive group of evidence users to achieve better healthcare for diabetes patients with established or at high risk of CVD or CKD.

Start: February 2021

Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease

This study is a 1:1 randomized controlled trial with an intervention for 18 months and a follow up period of 12 months. The purpose of the study is to assess the safety and efficacy of recombinant human parathyroid hormone for treatment of adynamic bone disorder in patients with chronic kidney disease.

Start: May 2021

Sarcopenia, Fall and Osteoporosis in Chronic Kidney Disease

This study is a cross-sectional study that wishes to investigate whether there is an increased incidence of sarcopenia in patients with chronic kidney disease compared to the Danish background population. A possible association between sarcopenia and fall, as well as the incidence of osteoporosis in patients with chronic kidney disease will also be described.

Start: March 2021

MRI Technical Development and Applications in Kidney Disease

Magnetic resonance imaging (MRI), as a non-invasive and non-contrast enhanced technique, has the potential to improve patient health care and management. The overall objective of proposed project is to: develop, customize, and optimize anatomic and functional MRI methods, explore the use of MRI methods to study CKD and evaluate post-transplant kidneys, and investigate the potential of MRI in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction. In addition to direct studies of the kidney, brain MRI studies will also be performed to identify the cerebrovascular and cognitive effects of chronic renal function deficiency and medical treatment (e.g. hemodialysis and immunosuppression). The brain and kidneys have similar vascular bed, and both are susceptible to vascular injury, which provides the pathological basis for the widely recognized association of reduced renal function with prevalent cerebrovascular diseases (CVDs) and cognitive impairment (CI). The MRI methods in the brain will be applied to explore the origins for widely observed CVDs and prevalent cognitive impairment (CI) in kidney disease patients.

Start: August 2017

Propolis for Patients With Chronic Kidney Disease.

To evaluate the effects of alcoholic propolis extract on inflammation in participants with chronic kidney disease. Specific objectives To assess before and after the intervention period: The expression of transcription factors (nuclear factor-kB), antioxidant enzymes (heme-oxygenase-1), inflammasome receptor, peroxisome proliferator-activated receptor-?, as well as the levels of inflammatory cytokines (IL-6, Tumor nuclear factor-?, C-reactive protein, interleukin 1) and E-selectin adhesion molecules; The levels of protein expression of inflammatory markers and antioxidant enzymes; The profile of the intestinal microbiota of stool samples from the research participants; Plasma levels of substances reactive to thiobarbituric acid and oxidized low density lipoprotein as a marker of oxidative stress; Routine and anthropometric laboratory variables, indicative of the metabolic profile of the research participants; Assess blood pressure, 6-minute walk test, recovery heart rate and chair lift test to assess the functional capacity of the research participants; Assess atherogenic risk; Food intake and nutritional status; Compare data between the intervention and control groups.

Start: January 2021

FGF19 and Chronic Kidney Disease

Sarcopenia in chronic kidney disease (CKD) affects 50% of dialysis patients and 20% of patients with non-dialyzed CKD and reduce quality of life and survival. The pathophysiology of uremic sarcopenia is multifactorial (accumulation of toxins, metabolic disturbances, etc.) and poorly characterized. These pejorative factors are associated with malnutrition and a sedentary lifestyle. Currently, there are no strategies to combat sarcopenia with the exception of physical activity, which is only possible for a limited number of patients due to their comorbidities. Developing new pharmacological strategies to combat sarcopenia is necessary. FGF19 is a growth factor produced in the ileum involved in metabolic homeostasis. In the laboratory, a new function of FGF19 has been discovered. FGF19 acts as a hormonal factor stimulating muscle mass and strength. Preliminary studies had shown a decrease in the concentration and secretion of FGF19 in response to a meal in haemodialysis patients. However, the link between FGF19, muscle mass and CKD has never been demonstrated. The aim of this study is to assess the relationship between the concentration and secretion of FGF19 and muscle function in a large population of patients with CKD of different stages. Given the hormonal communication between the bone and the muscle, the investigators will also recover the bone histological parameters from a bone biopsy if dialysis patients are to benefit from this as part of their follow-up. The investigators hypothesize that a decrease in FGF19 concentration and secretion in CKD is associated with a decrease in muscle mass and strength.

Start: June 2021

Combination of Novel Therapies for CKD Comorbid Depression

The overall goal of the study is to determine if treatment of a Major Depressive Disorder (MDD) improves the outcomes of patients with chronic kidney disease (CKD). We showed that MDD is present in 25% of CKD patients and independently associated with progression to End-Stage Kidney Disease, hospitalization, and death. Depression is also associated with lower quality of life (QOL), fatigue, poor sleep, and non-adherence to diet and medications. However, evidence for efficacy and tolerability of commonly-used antidepressant medications or nonpharmacologic treatments are limited in CKD patients. Our group was the first to conduct a double-blind randomized controlled trial for MDD treatment in 201 patients with non-dialysis CKD, and showed that sertraline, a commonly used selective serotonin reuptake inhibitor (SSRI), was no more efficacious than placebo for improving depressive symptoms. It becomes imperative to test novel strategies to treat MDD in CKD. We propose to compare with a control group, the efficacy and tolerability of two novel treatment strategies - (1) Behavioral Activation Teletherapy (BAT) for 16 weeks, with the addition of bupropion, a non-SSRI antidepressant, at 8 weeks for patients whose depression has not remitted (non-remitters); and (2) bupropion for 16 weeks, with the addition of BAT at 8 weeks for non-remitters. In Aim 1, we will investigate the efficacy and tolerability of these 2 strategies vs. control for improvement in a primary endpoint of depressive symptoms in 201 patients (67 per group) with non-dialysis CKD stages 3b-5 and MDD at 2 sites, randomized 1:1:1 to either strategy or a control group of Clinical Management plus placebo. We hypothesize that either approach vs. control will result in a minimal clinically important difference of 2 points improvement in depressive symptoms, as ascertained blindly by the Quick Inventory of Depressive Symptomatology. In Aim 2 we will investigate the efficacy and tolerability of 8 weeks of (1) single-blind BAT plus placebo or (2) double-blind bupropion plus Clinical Management vs. control for improvement in depressive symptoms. In Aim 3, we will compare the efficacy of these 2 treatments strategies vs. control for improvement in CKD patient-centered outcomes including a. adherence to medications and healthcare visits; b. fatigue; c. sleep; and d. overall functioning. A clinical trial is urgently needed to address the evidence gap that exists for MDD treatment in CKD patients.

Start: September 2020

American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)

Despite many advances in our understanding of the natural history and progression of chronic kidney disease (CKD) and cardio vascular disease (CVD) in the parent CRIC study over the past 15 years, important questions about key risk factors for these diseases remain unanswered in the AI population. To address this burden of CKD in AI communities Investigators formed a consortium of investigators with extensive experience in conducting research of chronic diseases including diabetes, cardiovascular and kidney disease in AIs of Southwestern US. The proposed CRIC ancillary cohort study of 500 AIs (AI-CRIC) will rapidly improve our understanding of both potential risk factors for CKD progression, as well as the scope of this disease among AIs. This study leverages the current CRIC study and incorporates the planned activities of the next phase of the study - "CRIC 2018" - by implementing contemporary CRIC protocols for kidney and cardiovascular measurement and outcomes.

Start: August 2020

Troponin Excretion in Urine in Patients With and Without Chronic Kidney Disease

In this study, in order to better understand the mechanism of troponin clearance and the reason for elevated troponin levels in patients with CKD, we aim to evaluate quantitatively the excretion of troponin in the urine in patients with and without CKD, and with and without myocardial injury. We will compare urinary troponin levels with blood troponin levels in these patients. In addition, we will compare the levels of hs-cTnT and hs-cTnI in the patients' sera and urine.

Start: January 2020

Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role?

This study aims at evaluating, in chronic kidney disease patients on dialysis, the effect of acute per- or pre-dialytic physical exercise on regional myocardial function and myocardial stunning, blood viscosity, arterial stiffness, variability of sinus rhythm, dialysis efficacy, inflammation, mineral and bone disorders, myokines and cardiac remodeling markers.

Start: September 2021

Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury

Multi-center randomized trial to assess the safety and performance of low-frequency therapeutic ultrasound for maintaining renal function after contrast exposure.

Start: July 2021

Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease

The purpose of this study to test whether n-of-1 trial-guided clinical decision-making improves blood pressure control in hypertensive children with chronic kidney disease (CKD) and end-stage renal disease (ESRD).

Start: January 2021

Long Term Efficacy and Safety of COVID-19 (SARS-CoV-2) Vaccination in Kidney Disease Patients

Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with chronic kidney disease stage G4-G5 and patients on dialysis or after kidney transplantation. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded these patients so-far. Literature data indicate that vaccination may be less effective in these patient groups. Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, patients on dialysis or after kidney transplantation during two years follow-up after vaccination. Study design: prospective single center observational cohort study. Study population: all Dutch patients on dialysis with data registered in the Dutch Dialysis registry (RENINE) all Dutch patients after kidney transplantation with data registered in the Dutch national kidney transplant registry (NOTR). All Dutch patients with chronic kidney disease stage G4-G5 registered in the Santeon hospitals. Intervention: After SARS-CoV-2 vaccination according to standard of care, blood will be drawn for antibody response measurements at day 28 and month 6 after 2nd vaccination at by mailer-based finger-prick in 3400 hemodialysis patients, 600 peritoneal dialysis patients, 4000 patients after kidney transplantation and 4000 patients with chronic kidney disease stage G4-G5 Main study parameters/endpoints: The primary endpoint is efficacy of SARS-CoV-2 vaccination determined as: - the incidence of COVID-19 after vaccination. Secondary endpoints are the antibody based immune response at 28 days after completion of vaccination. the duration of antibody based immune response at 6 months compared to at 28 days after completion of vaccination. mortality adverse events of specific interest according to (inter)national authorities in collaboration with LAREB presence of HLA-antibodies in dialysis patients on the waiting list for a first kidney transplantation acute rejection and graft failure in patients after kidney transplantation The incidence of these endpoints will be compared, if applicable, to those: in the general population who are vaccinated in patients on dialysis or after kidney transplant who are not vaccinated Within these patient groups endpoints will be compared between recipients of different vaccines.

Start: April 2021

The Kidney BEAM Trial

This is a multi-centre single-blind waitlist randomised controlled trial (RCT) that will examine the clinical value and cost-effectiveness of an online physical and emotional wellbeing resource for the improvement of health-related quality of life in people with CKD. Physical inactivity and poor mental health are very real concerns for people living with kidney disease, and they report multiple symptoms that impact upon the physical component of health-related quality of life (HRQoL). A decrease in the physical component of HRQoL is independently associated with mortality and morbidity. In people living with end stage kidney disease (ESKD), systematic reviews indicate that a range of exercise training interventions improve physical function and alleviate disability symptoms. The physical component of HRQoL can be targeted with interventions to enhance physical activity, however people living with kidney disease are still not routinely offered specialist physical activity or mental health support in the NHS. Kidney Beam is a new wellbeing digital health intervention platform that was developed, and launched, to help people with kidney disease manage their physical and mental health through the Coronavirus 2019 (COVID-19) pandemic, resulting lockdown and beyond. It involves a digital health intervention platform to support people with health conditions to stay physically active. Patients will have access to live-on demand or recorded physical activity classes that they will use for 12 weeks with 2 sessions per week. The study aims to recruit 304 patients.

Start: April 2021

Rural Home Hospital: Proof of Concept

This study examines the implications of providing hospital-level care in rural homes.

Start: February 2021

Stem Cell Therapy for Chronic Kidney Disease

The purpose of this study is to assess the safety and tolerability of allogeneic mesenchymal stem / stromal cell therapy in individuals with chronic kidney disease.

Start: May 2021