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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT03535922 Active, not recruiting - Clinical trials for Chronic Kidney Disease Requiring Chronic Dialysis

Evaluation of Routinely Measured Patient-reported Outcomes in Hemodialysis Care

EMPATHY
Start date: September 17, 2018
Phase: N/A
Study type: Interventional

Patient-reported outcome measures (PROMs) are reports coming directly from patients about how they function or feel in relation to a health condition and its therapy, without interpretation of the patient's responses by a clinician or anyone else. PROMs capture patients' experiences of symptoms and impact of disease on functioning and can support clinicians to monitor disease progression and facilitate patient-centered care. The EMPATHY trial will determine the effects of routinely measuring PROMs on the experiences of patients undergoing hemodialysis in Alberta and Ontario. In this study, two kinds of PROMs will be used: a disease-specific PROM and a generic PROM. The disease-specific PROM focuses on health symptoms related to kidney failure and the generic PROM focuses on general health. In the trial, patients will be invited to complete the PROMs, and results of the measures will be linked to treatment aids for clinicians, providing specific information on how symptoms can best be managed. These care pathways will also be available to patients not receiving PROMs. The main outcome of this study will be patient-clinician communication, which will be assessed using a questionnaire called the "Communication Assessment Tool". In addition to assessing the effect of using these questionnaires on patient-provider communication, this study will allow us to explore whether their use affects patient management and symptoms, use of healthcare services, and the overall cost of implementing these questionnaires in clinical practice. Each dialysis unit (including all patients) will be randomized to one of four study groups: 1) Patients will complete the disease-specific PROM; 2) Patients will complete the generic PROM; 3) Patients will complete both the disease-specific and generic PROM; 4) Patients will receive usual care. Clinicians (in dialysis units randomized to PROMs, groups 1-3) will receive the results of the questionnaires completed by the patients. This is intended to trigger the clinician to ask the patient about certain symptoms if any exist. All clinicians in all study groups will have access to the clinical "treatment aids", which are tools that help identify and manage certain symptoms that patients might have. For example, people with severe itching will be cared for based on a step-wise treatment algorithm. Patients will also receive a report of their questionnaire(s) results, with an explanation of what it means.

NCT ID: NCT03474367 Active, not recruiting - Clinical trials for Chronic Kidney Disease Requiring Chronic Dialysis

Cost-effectiveness of Urgent-start Therapies Hemodialysis and Peritoneal Dialysis

Start date: April 1, 2017
Phase:
Study type: Observational

This study will evaluate the cost-effectiveness of unplanned dialysis (peritoneal dialysis and hemodialysis) in chronic kidney disease (CKD) during the first year of therapy in a single center.

NCT ID: NCT03470961 Active, not recruiting - Diabetes Mellitus Clinical Trials

Observational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients

PAISPK
Start date: March 1, 2018
Phase: Phase 4
Study type: Interventional

A single-centre, prospective, observational study to evaluate the safety and efficacy of Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients.

NCT ID: NCT03386539 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score

TEAMMATE
Start date: January 29, 2018
Phase: Phase 3
Study type: Interventional

The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years. Half of the participants will receive everolimus and low-dose tacrolimus and the other half will receive tacrolimus and mycophenolate mofetil. The trial will determine which treatment is better at reducing the cumulative risk of coronary artery vasculopathy, chronic kidney disease and biopsy proven-acute cellular rejection without an increase in graft loss due to all causes (e.g. infection, PTLD, antibody mediated rejection).

NCT ID: NCT03385902 Active, not recruiting - Clinical trials for Chronic Kidney Disease

Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation

ADIFE
Start date: April 14, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the impact of the optimal and late initiation of dialysis on the mortality and quality of life in end-stage renal disease (ESRD) patients by the Dialysis Initiation based on Fuzzy mathematics Equation (DIFE), which is a novel equation for the assessment of timing of dialysis initiation established by Fuzzy mathematics.

NCT ID: NCT03381950 Active, not recruiting - Clinical trials for Renal Insufficiency, Chronic

Chronic Kidney Disease - Renal Epidemiology and Information Network

CKD-REIN
Start date: July 2013
Phase:
Study type: Observational

Preserving kidney function and improving the transition from CKD to End stage renal disease (ESRD) is a research and healthcare challenge. The Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) cohort was established to identify the determinants, biomarkers and practice patterns associated with chronic kidney disease outcomes. The study includes 3,033 adult patients with moderate to advanced CKD from a representative sample of 40 nephrology clinics in France with respect to regions and legal status. Patients are recruited during a routine visit and followed up for 5 years, before and after starting renal replacement therapy. Patient-level clinical, biological, and lifestyle data are collected annually, as well as provider-level data on clinical practices, coordinated with the International Chronic Kidney Disease Outcomes and Practice Pattern Study (CKDopps). Blood and urine samples are stored in a biobank. The overall objective is to develop a research platform to address key questions regarding the determinants and biomarkers associated with adverse outcomes in CKD and to assess its effective management. It has the following hypotheses and specific aims: 1. to evaluate a large set of social, environmental, bioclinical, and genetic factors, and their interactions in relation with CKD outcomes including progression to ESRD, mortality, metabolic and vascular complications, and the onset of a number of chronic and acute events; 2. to assess several new biomarkers to predict adverse outcomes of CKD and its complications; 3. to evaluate the associations of provider practices (management of hypertension, anemia, nutritional abnormalities, mineral and bone disorder, nutritional status, timing of dialysis initiation and transplant wait-listing) with achievement of clinical practice guidelines, clinical and patient-reported outcomes (PRO). 4. to evaluate the associations of health care organization and clinic services (e.g., for nutrition, educational programs) with clinical and patient-reported outcomes, and achievement of clinical practice guidelines; 5. to estimate the relative cost-effectiveness of different provider practices and clinic services.

NCT ID: NCT03356990 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

Effects of Resistant Starch Diet on the Gut Microbiome in Chronic Kidney Disease

Start date: February 12, 2018
Phase: N/A
Study type: Interventional

The investigators want to learn more about how to help people who have chronic kidney disease (CKD). This study will increase the investigators understanding of how diet affects factors that can slow the progression of kidney disease. The investigators are asking 30 adults and 30 children with stage 3 CKD to be part of this study. Participants will supplement their diet with resistant starch for two weeks. The investigators anticipate that the resistant starch will change the bacteria in the intestines to a more beneficial type of bacteria. The investigators will measure a product of these beneficial bacteria called butyrate. The investigators will also determine changes in the gut bacteria and products of the bacteria in the blood.

NCT ID: NCT03350425 Active, not recruiting - Pneumonia Clinical Trials

Duration of Protection From Pneumonia After Pneumococcal Vaccination in Hemodialysis Patients

DOPPIO
Start date: December 21, 2017
Phase:
Study type: Observational

The investigators compare two strata of vaccinated patients: those recently vaccinated and those vaccinated more than two years ago. The primary objective is to compare pneumonia rates between the groups. As exploratory objectives, the investigators will describe the anti-pneumococcal antibody titers in hemodialysis patients as a function of time since vaccination, and determine factors influencing antibody kinetics. Further exploratory objectives investigate the relationship between antibody titers and the incidence of pneumonia in hemodialysis patients and extrapolate a possible cut-off for protection from pneumonia.

NCT ID: NCT03348592 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

Gut Microbiome and p-Inulin in CKD - TarGut CKD Study

TarGut
Start date: October 2016
Phase: N/A
Study type: Interventional

The purpose of this Phase 1, 3-period crossover with repeated measures feasibility study is to characterize the gut microbiome of individuals with chronic kidney disease, and to explore effects of p-inulin on the gut microbiome. The nature of the study will provide information about the feasibility of stool sample collection for future multicenter studies of the gut microbiome.

NCT ID: NCT03285854 Active, not recruiting - Clinical trials for Chronic Kidney Disease Mineral and Bone Disorder

Calcium Balance Studies in Children With CKD and on Dialysis

Cal-Bal
Start date: February 1, 2017
Phase:
Study type: Observational

This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope fractionation.