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Renal Insufficiency, Chronic clinical trials

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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: NCT03379571 Completed - Clinical trials for Chronic Kidney Diseases

Competing Risk of Death and ESRD in Incident CKD Patients

EPIRAN
Start date: January 1, 2004
Phase: N/A
Study type: Observational

Although chronic kidney disease (CKD) affects a growing number of people, epidemiologic data on incident CKD in the general population are scarce. Screening strategies to increase early CKD detection have been developed. Methods: From a community-based sample of 4,409 individuals residing in a well-defined geographical area, investigators determined the number of patients having a first serum creatinine value ≥1.7 mg/dL and present for at least 3 months that allowed us to calculate an annual incidence rate of CKD (stages 3 to 5). CKD (stages 3 to 5) was defined by estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Investigators also described the primary care, outcomes and risk factors associated with outcomes using competing risks analyses for these CKD patients.

NCT ID: NCT03378700 Not yet recruiting - Clinical trials for Chronic Kidney Diseases

Effects of a Brief Hope Intervention to the Decision Making

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

Introduction A Hong Kong study found that more than half of the chronic kidney disease (CKD) patients declined peritoneal dialysis (PD) and preferred receiving palliative care, although PD is vital for early preservation of residual kidney functions. Decision-making was found to be influenced by feelings of hopelessness, leading to underestimation and the pursuit of a successful plan of action. Cumulative evidences revealed that hope is a factor that heightens positive expectations in patients, and could lead to consideration of wider alternatives and thorough decision making. Aim The aim of this study is to examine the effectiveness of a brief hope intervention in reducing the decisional conflict and improving the quality of life of CKD patients who have to plan for receiving dialysis therapy. If patients' quality of decision-making could be improved, timely initiation dialysis and less decisional regret is expected. Method This study is a single-blinded randomised controlled trial. On completion of the baseline assessment and the screening procedure, eligible participants will be randomly assigned in equal number into either the experimental group (education programme plus a brief hope intervention) or the control group (education programme) using sets of computer-generated random numbers. Patients attending the outpatient renal clinic of a regional hospital in HK will be approached. Stage 5 CKD patients (GRF equal to or less than 15) who are planned to receive dialysis therapy or palliative care will be invited to join the study. Taking into consideration of attrition and the health status of the palliative care patients, it was appropriate to sign up 36 participants per arm, correlation alpha value 0.6, 0.5 effect size with a power of 0.70. There are four waves of data collection, which will be done before the commencement of the intervention (T1), immediately post-intervention (T2) and one month (T3) and three months (T4) after the completion of programme. Primary Outcomes include the assessing the patients' decisional conflict, strength of preference, on their choice of treatment modalities between peritoneal dialysis and palliative care, and health resources utilization. Secondary outcomes measure hope level change and quality of life. Sociodemographic and socioeconomic information will be collected. Two open-ended questions will be used to explore the perceived impact and benefits of the intervention.

NCT ID: NCT03377413 Completed - Clinical trials for Chronic Kidney Disease

Novel Equation for Estimating Resting Energy Expenditure

Start date: December 14, 2017
Phase:
Study type: Observational

The energy and nutrition states are closely associated with CKD patients complications and outcomes.To reach the energy balance target, we need the accurate resting energy expenditure level of patients. Traditional equations are not applicable to CKD patients,so we aim to develop and validate a equation for estimating resting energy expenditure in CKD patients.

NCT ID: NCT03367338 Completed - Hyperphosphatemia Clinical Trials

Low-Phosphate Diet and Fibroblast Growth Factor-23 Level

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

The aims of the study are to evaluate the effect of low-phosphate diet on FGF23 level and to determine the optimal amount of dietary phosphate restriction in hemodialysis patients. In particular, the investigators will assess the comparing effect of pre-specified low-phosphate diets, very low-phosphate diet, phosphate-to-protein ratio (PPR) value of 8 mg/g, versus low-phosphate diet, PPR value of 10 mg/g, on the change of FGF23 and phosphate level.

NCT ID: NCT03366337 Completed - IgA Nephropathy Clinical Trials

A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX

PHOENIX
Start date: December 26, 2017
Phase: Phase 2
Study type: Interventional

This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes (T1D), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and autosomal dominant polycystic kidney disease (ADPKD). Patients will be enrolled in disease specific cohorts within the trial, and effectiveness of bardoxolone methyl in treating CKD will be assessed separately by cohort for each rare CKD. All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 1, 2, 4, 6, 8, and 12, and by telephone contact on Days 3, 10, 21, 31, 38, and 45. Patients will also be scheduled to be assessed at an in-person follow-up visit at Week 16, four weeks after the end of treatment.

NCT ID: NCT03365063 Recruiting - Clinical trials for Chronic Kidney Disease

Integrating Risk-based Care for Patients With CKD

Start date: August 24, 2018
Phase: N/A
Study type: Interventional

Chronic kidney disease (CKD) and its end stage of kidney failure are major public health problems in Canada and worldwide. In the primary care setting, accurate prediction of the risk of kidney failure in patients with CKD can improve patient provider communication, assist in appropriate nephrology referral, improve dialysis treatment planning, and identify patients who are most likely to benefit from intervention. To aid in accurately predicting the risk of kidney failure requiring dialysis in patients with CKD, the primary investigator has developed and validated the kidney failure risk equation (KFRE), which is increasingly used in nephrology practices across Canada and the United States. In this current study, a cluster randomized controlled trial (RCT) will be done in collaboration with the Canadian Primary Care Sentinel Surveillance Network (CPCSSN). Primary care clinics that can integrate the KFRE into their electronic medical records will be randomized to receive the intervention (patients and providers receive individualized information explaining kidney failure risk, as well as risk-based criteria for referral, alongside usual care) versus usual care alone (no information on personalized risk and no risk-based referral). In both groups, the investigators will assess management of patients at high risk of kidney failure (patient), timing of referral for patients at high risk of kidney failure (health system), cost of CKD care (health system), CKD-specific health literacy (patient), trust in physician care (patient), and satisfaction with risk prediction tools (provider). The objective of this research study is to develop, implement, and evaluate tools to guide the care of patients with CKD in the community, including appropriate referral using a risk-based approach. Specifically, this study will address the question: "Does providing patients (and their physicians) with information about their risk of kidney failure improve quality of care, health literacy, and trust in the care they are receiving?"

NCT ID: NCT03362983 Completed - Clinical trials for Cardiovascular Diseases

Integrated, Multidisciplinary, Person-centered Care for Patients With Complex Comorbidities: Heart, Kidney and Diabetes

CareHND
Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Patient with complex comorbidities present a growing challenge for health-care providers, that the current system is poorly designed to handle. Concomitant cardiovascular disease, renal dysfunction and diabetes represent almost half of all patients attending cardiac, kidney and diabetes clinics. Patients with all three of these will be randomized to standard care or to a combined, integrated, person-centered, intensified chronic disease management.

NCT ID: NCT03361280 Completed - Clinical trials for Chronic Kidney Diseases

Removal of Beta Blocker Drugs by Hemodialysis

Start date: February 27, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Eight maintenance hemodialysis patients are given one of four beta blocker drugs (atenolol, bisoprolol, carvedilol, metoprolol) three hours prior to a hemodialysis session. Blood samples and spent dialysate are collected during dialysis. On separate dialysis sessions, patients received the other study drugs until they have taken each of the four study drugs. Dialytic clearance is calculated.

NCT ID: NCT03358966 Completed - Clinical trials for Chronic Kidney Diseases

Energy Expenditure in Chronic Kidney Disease

Start date: September 1, 2008
Phase: N/A
Study type: Observational

Patients with kidney disease need accurate advice on their diet. Researchers know very little about energy needs and nutritional requirements in kidney patients. Simple tools are needed to calculate calorie requirements so that good bed-side advice can be given to patients, and to allow cost-effective research. This study aimed to measur energy requirements in kidney disease using a gold-standard safe and very accurate method called the "doubly labelled water technique". The study has compared measurements with less costly measurements obtained using a device which measures oxygen content of air breathed out. The study has also measured physical activity levels with questionnaires.