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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT04659525 Recruiting - Clinical trials for Hypercholesterolemia

Evolocumab Plus Ezetimibe in Haemodialized Statin-intolerant Patients With Hypercholesterolemia

Start date: November 1, 2020
Phase: Phase 4
Study type: Interventional

Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol, reducing in turn the risk of cardiovascular events. Whether evolcumab is effective in haemodialized patients is uncertain. The investigators will conduct a randomized, double-blind, placebo-controlled trial to assess the feasibility, safety, and LDL-C-lowering efficacy of evolocumab in high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia. Patients will be randomly assigned to receive evolocumab (140 mg subcutaneous every 2 weeks + ezetimibe 10 mg per os daily) or matching placebo (subcutaneous every 2 weeks + ezetimibe 10 mg per os daily) for 24 weeks. The primary efficacy end point will be the proportion of patients that will reduce LDL-C < 55 mg/dL in the evolocumab group compared to placebo at 24 weeks. The key secondary efficacy end points will be: the reduction of LDL-C from baseline at 4, 6 and 12 weeks; the reduction of HDL-C, non-HDL cholesterol and triglycerides from baseline at 24 weeks. Every adverse event (serious and non-serious) correlated to drug infusion will be recorded (safety end-point).

NCT ID: NCT04646408 Recruiting - Clinical trials for Cardiovascular Diseases

Determinants of Cardiovascular Disease, Kidney Disease and Diabetes

Start date: October 1, 2020
Phase:
Study type: Observational

Cardiovascular disease (CVD), chronic kidney disease (CKD), diabetes mellitus (DM) and HIV infection are long-term conditions (LTC) with major health implications for people of African ancestry. These LTC often arise in the setting of an adverse demographic, social, biologic and genetic environment, although this remains poorly understood. The investigators plan to conduct a comprehensive syndemic evaluation in individuals with and without CVD, CKD and DM in people of African ancestry with HIV to obtain novel insights into the development of LTC in this population. In addition, the investigators will conduct focus groups to explore the role of syndemic factors in the development of LTC and develop and pilot an educational programme to improve knowledge about LTC in the African/Caribbean community.

NCT ID: NCT04626323 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease

OBESE-DKD
Start date: May 25, 2021
Phase: Phase 2
Study type: Interventional

Proven therapy for DKD is primarily limited to RAAS blockers and SLGT2i. Weight reduction has the potential to become an additional and much needed treatment option. Of all the weight reduction strategies metabolic surgery is suited to be the most effective. Yet no study has of yet compared the effect of metabolic surgery against best medical treatment on the progression of DKD. This pilot trial is designed to be the first determine the efficacy of metabolic surgery in slowing progression of DKD as compared to best medical therapy. The study design will address all the major limitations previously documented, including the major dilemma of estimating versus measuring GFR. Of note, the study's design will allow its sample size to be adjusted upward using an adaptive design if necessary, to achieve statistical significance. It will also inform study design and sample size issues for all future studies in this field. The payoff of establishing metabolic surgery as a new and effective intervention to slow progression to ESRD would be great in terms of reducing patient suffering and societal costs. This will be an open-label, randomized trial involving sixty (60) patients with diabetic kidney disease (DKD) and obesity who will undergo Roux-en-Y gastric bypass (RYGB) in the intervention arm or receive best medical treatment (BMT) in the control arm. The aim of this prospective, open, randomized study is to evaluate the efficacy and safety of RYGB surgery versus best medical treatment on the progression of DKD in patients with type 2 diabetes and obesity.

NCT ID: NCT04626167 Recruiting - Clinical trials for Chronic Kidney Diseases

Concomitant Renal and Urinary Bladder Allograft Transplantation

Start date: June 1, 2021
Phase: Early Phase 1
Study type: Interventional

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

NCT ID: NCT04611334 Recruiting - Clinical trials for Chronic Kidney Diseases

The Effects of HRV Biofeedback on Chronic Kidney Disease Patient.

Start date: September 17, 2020
Phase: N/A
Study type: Interventional

The prevalence and incidence of end-stage renal disease in Taiwan ranks highest in the world, and it is based on the 2018 health welfare According to statistics from the Ministry of Foreign Affairs, kidney disease is the ninth leading cause of death in Taiwan. As the course of chronic kidney disease (CKD) progresses, autonomic nervous system dysfunction, inflammation, and physical and psychological symptoms (such as fatigue, sleep disturbance, and depression) will increase, which will further damage the structure and function of the kidney Intensified, increasing the demand for dialysis treatment and the risk of cardiovascular disease, which consumes social and medical costs. If the investigators can intervene in a feasible measure to effectively regulate the autonomic nervous function of CKD patients, reduce inflammation and physical and psychological symptoms, and delay the progression of the disease, it will be the main goal of caring for CKD patients. To explore the intervention of heart rate variability biofeedback, which can improve the autonomic nervous function (heart rate variability [Heart Rate Variability]), inflammatory response (interleukin-6 [Interleukin-6, IL-6], C-reactive protein [ C reaction protein, CRP]) and physical and psychological symptoms (such as reducing fatigue, sleep disturbance and depression).

NCT ID: NCT04584905 Recruiting - Clinical trials for Nutrition Disorders, Child

Nutritional Assessment of Children With Chronic Kidney Disease

Start date: January 1, 2021
Phase:
Study type: Observational

Primary outcome is assessment of nutritional status of children with CKD. Secondary outcome is assessment STAMP screening tool for detection of malnutrition of CKD children.

NCT ID: NCT04581694 Recruiting - Renal Failure Clinical Trials

Transcatheter Implantation of Aortic Bioprosthesis Without the Use of Iodinated Contrast in Patients With Chronic Kidney Disease

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Acute renal failure (ARF) after transcatheter aortic valve implantation (TAVI) is a frequent complication, with significant clinical consequences. History of chronic kidney disease and the use of a large amount of iodinated contrast for planning and procedure are among the main risk factors for the development of this complication. The present study aims to: (1) define the role of non-contrast imaging modalities in pre-procedure planning; (2) evaluate the feasibility and safety of a new TAVI technique without using iodinated contrast; (3) to determine the incidence of acute renal failure in patients with aortic stenosis and chronic kidney disease undergoing TAVI, using the new technique without contrast. The study will be divided into two stages. In the pilot phase, 25 consecutive patients with chronic kidney disease (stage ≥ 3a) will have the TAVI planning and procedure performed without the use of iodinated contrast, but with all the steps subjected to verification by the standard technique, to ensure the safety of the patient. The occurrence of the combined primary safety outcome composed of adverse clinical events within 30 days (defined by the VARC-2 criteria) in less than 20% of cases will be used to define the continuity of the study. In the second phase, 50 patients with chronic kidney disease stage ≥ 3b will be submitted to TAVI with the "zero contrast" technique. The primary outcome assessed at this stage of the study will be the incidence of AKI within 7 days after TAVI using the new technique in this high-risk population.

NCT ID: NCT04564924 Recruiting - Clinical trials for Chronic Kidney Disease-Mineral and Bone Disorder

To Investigate the Bone and Muscle Abnormalities in Patients With Chronic Kidney Disease With MRI

Start date: September 2, 2020
Phase:
Study type: Observational

Patients with chronic kidney disease (CKD) have a higher risk of fractures than those without. The purpose of this study is to develop a non-invasive Magnetic resonance imaging (MRI) method that can improve fracture risk prediction and provide early diagnosis for bone abnormalities in patients with CKD.

NCT ID: NCT04542304 Recruiting - Clinical trials for Chronic Kidney Disease

Efficacy of Diuretics in Kidney Disease

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

This study will determine the efficacy of diuretics in patients with chronic kidney disease.

NCT ID: NCT04523727 Recruiting - Clinical trials for Hyperphosphatemia Related to Chronic Kidney Disease

Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease

Start date: June 8, 2023
Phase: Phase 3
Study type: Interventional

This study will be conducted to assess the safety and tolerability of ferric citrate in pediatric participants with hyperphosphatemia related to chronic kidney disease (CKD).