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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT04999436 Enrolling by invitation - Clinical trials for Chronic Kidney Diseases

APOL1 Genetic Testing Program for Living Donors, Part 2

Start date: July 19, 2022
Phase: N/A
Study type: Interventional

Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly using APOL1 testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counseling with LD candidates about APOL1 due to a lack of knowledge and skill in counseling about APOL1. Without proper counseling, APOL1 testing will magnify LD candidates' decisional conflict about donating, jeopardizing their informed consent. Given their elevated risk of ESRD post-donation, and AAs' widely-held cultural concerns about genetic testing, it is ethically critical to protect AA LD candidates' safety through APOL1 testing in a culturally competent manner to improve informed decisions about donating. No transplant programs have integrated APOL1 testing into LD evaluation in a culturally competent manner. Clinical "chatbots," mobile apps that use artificial intelligence to provide genetic information to patients and relieve constraints on clinicians' time, can improve informed treatment decisions and reduce decisional conflict. The chatbot "Gia," created by a medical genetics company, can be adapted to any condition. However, no chatbot on APOL1is currently available. No counseling training programs are available for nephrologists to counsel AA LDs about APOL1 and donation in a culturally competent manner. Given the shortage of genetic counselors, increasing nephrologists' genetic literacy is critical to integrating genetic testing into practice. The objective of this study is to culturally adapt and evaluate the effectiveness of an APOL1testing program for AA LDs at two transplant centers serving large AA LD populations (Chicago, IL, and Washington, DC). The APOL1 testing program will evaluate the effect of the culturally competent testing, chatbot, and counseling on AA LD candidates' decisional conflict about donating, preparedness for decision-making, willingness to donate, and satisfaction with informed consent. The specific aims are to: 1. Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice 2. Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design 3. Evaluate the implementation of this intervention into clinical practice by using the RE-AIM framework to longitudinally evaluate nephrologist counseling practices and LDs' satisfaction with informed consent. The impact of this study will be the creation of a model for APOL1 testing of AA LDs, which can then be implemented nationally via implementation science approaches. APOL1 will serve as a model for integrating culturally competent genetic testing into transplant and other practices to improve patient informed consent.

NCT ID: NCT04872933 Enrolling by invitation - Clinical trials for Chronic Kidney Diseases

The Kidney BEAM Trial

Start date: April 21, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04502784 Enrolling by invitation - Anemia Clinical Trials

Investigation of Hypophosphataemia Following Intravenous Iron

Start date: October 7, 2019
Phase:
Study type: Observational

Anaemia (low haemoglobin levels) can develop in a number of conditions, including chronic kidney disease (CKD) and intestinal conditions (e.g. inflammatory bowel disease, intestinal failure). Intravenous iron can be given to patients with these conditions to help correct their aneaemia. However, intravenous iron has been associated with the development of low phosphate levels - hypophophosphataemia. The aim of this study is to determine potential causes of hypophosphataemia following administration of intravenous iron.

NCT ID: NCT04491227 Enrolling by invitation - Covid19 Clinical Trials

Global Assessment of Acute and Chronic Kidney Disease Incidence and Outcomes in Patients With COVID-19 Infection

Start date: May 5, 2020
Phase:
Study type: Observational

The coronavirus (COVID-19) pandemic has created a significant strain on health care resources across the world for managing critically ill patients. Emerging reports from China, South Korea and Italy have reported varying incidence of acute kidney (AKI) ranging from 5-15% with a mortality of 60-80% however there is no systematic assessment of the risk factors, recognition, course and outcomes in patients with and without kidney disease whose course is complicated by AKI1-4. Patients with underlying CKD, immunosuppressed patients with renal transplants and ESKD patients are at high risk for COVID-19 infection and there is limited information on the effect of COVID-19 on the course and outcomes of these patients. The requirement for renal support including IHD, CRRT and sorbent based therapies has been variable and has contributed to the intense pressure on the nephrology and critical care providers for delivering these therapies. As the COVID-19 pandemic expands in the USA and abroad, there is an intense need to understand the epidemiology of the disease and the resources needed for renal support to inform clinical management and public health interventions. In this study, the investigators aim to investigate health care facilities across the world (hospital wards, ICU, outpatient clinics, nursing homes, healthcare centers) to draw a global picture of incidence, risk factors, resources available for treatment and prognosis of acute and chronic kidney disease in patient with COVID 19 confirmed infection. The aim is to identify trends in patients with acute and chronic kidney disease, determine its incidence, treatment and outcomes in different settings across the world. This information will be used to develop and implement educational tools and resources to prevent deaths from AKI and progression of CKD in this and following pandemics.

NCT ID: NCT04470063 Enrolling by invitation - Clinical trials for Anemia Associated Chronic Kidney Disease

Multi-dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DDO-3055 Tablets in Patients With Anemia of Non-dialysis Chronic Kidney Diseases.

Start date: November 17, 2020
Phase: Phase 1
Study type: Interventional

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in patients with anemia of non-dialysis chronic kidney diseases.

NCT ID: NCT04297592 Enrolling by invitation - Diabetes Clinical Trials

Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Start date: June 11, 2020
Phase: Phase 4
Study type: Interventional

To determine the effectiveness of a 7-day course of an oral, prophylactic antibiotic on the incidence of periprosthetic joint infection and wound complications following primary total hip and knee arthroplasty in a high-risk patient population.

NCT ID: NCT03451929 Enrolling by invitation - Clinical trials for Chronic Kidney Diseases

Kidney Function and Cardiovascular Events: Cohort Study in General Population

EPIRCE
Start date: January 9, 2015
Phase: N/A
Study type: Observational

Prospective multicenter follow-up study of 10 years. Cohort established between 2005-2007 with stratified random sample of general population older than 20 years (Census 2001), N= 2746 subjects.

NCT ID: NCT02887391 Enrolling by invitation - Clinical trials for End Stage Renal Failure on Dialysis

Comparing Nutritional Status of In-centre Nocturnal Hemodialysis Patients to Conventional Hemodialysis Patients

Start date: January 2016
Phase: N/A
Study type: Observational

Although hemodialysis is life-saving, unfortunately, people on dialysis often have declining health, quality of life as well as poor nutritional status. Hemodialysis patients must follow a very restrictive diet, and many patients do not eat well and usually report poor appetites. A new approach to dialysis is being used in some hospitals in Alberta and elsewhere, called in-centre nocturnal hemodialysis. This in-centre nocturnal dialysis allows people to receive their dialysis at a hospital or clinic while they sleep. Since this in-centre nocturnal dialysis gives people 8-hour hemodialysis treatment 3 times per week (24 hours of dialysis per week) the patients have better removal of the waste products from their bodies than conventional hemodialysis (an average of 12 hours per week). Also of importance, when using in-centre nocturnal dialysis, people will have more time during the day to work, spend with family, as well as have time to shop for food, to cook and even to eat, which in turn will likely result in improvement in the quality of their lives. This study will follow 10 patients on conventional dialysis and 10 patients on in-centre nocturnal dialysis for 6 months and compare their food intake, muscle mass, weight, body mass index (BMI) and nutrition-related lab tests. The purpose of this study is to determine whether there is an improvement in the nutritional status of the in-centre nocturnal hemodialysis patients compared to the nutritional status of conventional hemodialysis patients.

NCT ID: NCT02848131 Enrolling by invitation - Clinical trials for Chronic Kidney Disease

Senescence in Chronic Kidney Disease

Start date: July 2016
Phase: Phase 2
Study type: Interventional

The study goal is to assess the effect of senescent cell clearance on senescence burden, physical ability or frailty, and adipose tissue-derived mesenchymal stem cell (MSC) functionality in patients with chronic kidney disease (CKD).

NCT ID: NCT02648126 Enrolling by invitation - Clinical trials for Renal Insufficiency, Chronic

Pure Red Cell Aplasia in Patients With Chronic Kidney Disease and in Use of Epoetin Alfa

Start date: November 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine occurrence of pure red cell aplasia in a group of participants with chronic renal insufficiency and with resistance criteria to epoetin alfa treatment.The investigational product is producted by Bio-Manguinhos / Fiocruz (BIO-EPO) and it is provided by the Unified Health System.