View clinical trials related to Chronic Kidney Diseases.
Filter by:This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).
Evaluation of Renastep is a 28-day long, prospective nutritional study that will recruit 15 patients aged between 3 and 18 years of age with Chronic Kidney Disease. Participants will incorporate Renastep into their renal specific diet, during which time they will record gastrointestinal symptoms, adherence to recommended intakes and thoughts on its palatability. A Baseline CRF completed by the Investigator at the start of the trial will record demographic information, GI history and the most recent renal bio-marker results. Bio-marker results recorded as part of routine care over the course of the study will be captured in the End of Study CRF. The study is designed to generate acceptability data that will be used to support an application to the Advisory Committee on Borderline Substances for Renastep to be reimbursable on prescription within the NHS.
Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI
The proposed research is clinical study evaluating the therapeutic benefits of resveratrol on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that resveratrol will improve endothelial function and functional performance by reducing oxidative stress and in conjunction with lowering markers of inflammation and oxidative stress.
It is estimated that over 25% of the world's population had hypertension in the year 2000 and that this proportion will reach 30% in the year 2025. With the introduction of the 2017 Guideline for High Blood Pressure in Adults from the American College of Cardiology and the American Heart Association Task Force on Clinical Practice Guidelines, the definition of hypertension became broader and as a result the prevalence is expected to further increase. On the other hand, it is estimated that around 10% of the world's population is affected by chronic kidney disease (CKD) with hypertension being both cause and complication of CKD. It is obvious that hypertension and CKD are interconnected and are both major risk factors for cardiovascular disease (CVD). Hypertension results in increased CVD risk both directly, as an independent factor, and indirectly via its negative impact on renal function. In fact, the deterioration of the renal function is proportional to the degree of hypertension. On the other hand, the more advanced the CKD is, the more challenging the management of hypertension becomes, as patients with CKD present altered patterns of blood pressure (BP) during the day and, additionally, the prevalence of white coat and masked hypertension is significantly higher in this group of patients. To date, hypertensive patients are treated according to the BP recordings that are obtained in the office (OBP) during routine patient visits, which leads to inaccurate estimates of the true burden of hypertension and also affects the efficacy of the therapeutic intervention. It has been suggested that self measured BP (HBP) is a more accurate estimate of the patients' daytime BP compared to the conventional office BP measurements. This has been already confirmed in studies regarding the general population and it has been suggested that the same applies to the patients with CKD. This study aims to check the validity of this hypothesis by comparing the effect of the HBP - guided management versus the conventional OBP - guided management on the 24 hour ambulatory BP monitoring of patients with uncontrolled hypertension and CKD stage 3 and 4.
This is a Phase 2 randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy, safety, and pharmacokinetics of KBP-5074 in patients with moderate-to-severe chronic kidney disease and uncontrolled hypertension.
Introduction: Diabetes mellitus (DM) is a very frequent pathology, which can lead to renal failure and the need for renal replacement therapy. In people with chronic kidney disease (CKD) and diabetes mellitus (DM), glycemic control is very important for the prevention of microvascular injury. In this context, the Nursing Process (NP) is the instrument to guide care, contributing to the attention of individuals' needs. Objective: To evaluate the results of Nursing Outcomes Classification (NOC), obtained through interventions of the Nursing Interventions Classification (NIC) for the glycemic control, in patients with diabetes in renal replacement therapy, with a diagnosis of Unstable Glycemia, of the North American Nursing Diagnosis - International (NANDA-I). Method: Randomized clinical trial in three dialysis services in southern Brazil. Population: Type I and II diabetes patients on hemodialysis. Sample: Over 18 years old, literate, who accept to participate in the study by signing a Term of Consent Free and Clarified. Exclusion criteria: severe uncorrected deficiency in hearing, speech, total amaurosis, degenerative neurological diseases, or score less than 20 in the Mini Mental State Examination. Randomization occurred by clusters, considering dialysis shifts. The CG followed routine treatment and guidelines, while the IG received nursing interventions on a monthly basis for 6 months. Variables related to NOC scores and the knowledge, attitude and self-care tests for DM were applied before and after the intervention period. After the intervention period, a washout period of 06 months will occur, after which the variables will be collected.
Introduction: Chronic Renal Failure affects a large part of the world population, being characterized by irreversible renal tissue damage, resulting in systemic disturbances that negatively affect the patient's life. The most commonly used treatment is hemodialysis, which also has certain deleterious effects, so it is necessary to look for therapies that minimize these complications. Objective: To analyze the influence of physical exercise during hemodialysis on the autonomic heart rate modulation, quality of life and physical functional ability in individuals with Chronic Renal Failure at Hospital das Clínicas Gaspar Vianna. Method: The intervention consists on performing aerobic exercise during hemodialysis. For the evaluation will be applied the KDQOL-SF ™ 1.3 questionnaire, for quality of life; 6-Minute Walk Test for physical functional ability; and cardiofrequencimeter for the autonomic heart rate modulation. Data will be stored in Microsoft Excel® spreadsheets, it will also be used for making graphs and tables. Statistical analysis will be performed in the Bioestat 5.3® program and the choice of tests will depend on the distribution and homogeneity of the data.
Background and importance: Hypertension is highly prevalent among Canadians with non-dialysis dependent chronic kidney disease (CKD). It is a modifiable risk factor for both cardiovascular (CV) events and CKD progression. Exercise is an effective strategy for blood pressure (BP) reduction in the general population but in people with CKD, hypertension is mediated by different causes (i.e. vascular stiffness, volume expansion) and it is unclear whether exercise will reduce BP in this population. Consequently, exercise resources are not offered in the routine multidisciplinary care of people with CKD and the prevalence of sedentary behaviour remains double that of the general population. The role of exercise in CKD management is also an important question for patients. From CIHR-supported workshops with patients, the role of lifestyle, such as exercise in CKD was a top research priority. Research aims: i.To determine the effect of exercise on mean ambulatory systolic blood pressure (SBP) in people with CKD compared to usual care. The investigators hypothesize that exercise training will significantly reduce BP compared to control. ii.To inform the design of a larger, multi-center trial evaluating the effect of exercise on the risk of CKD progression. Methods: A 160 participant, single center randomized trial of adults from Alberta Kidney Care North CKD clinics, Edmonton, Albert, Canada. Participants with an estimated glomerular filtration rate (eGFR) of 15-44 ml/min per 1.73m2 and SBP >130 mmHg will be randomized, stratified by eGFR (<30 versus ≥ 30) to an exercise intervention or usual care. The main outcome is the difference in 24-hour ambulatory SBP after eight weeks of exercise training between groups. Secondary outcomes include: BPs at eight and 24 weeks, dose of anti-hypertensives, aortic stiffness, CV-risk markers, CV fitness, 7-day accelerometry, quality of life, safety, and in an exploratory analysis, eGFR and proteinuria. The intervention is thrice weekly moderate intensity aerobic exercise supplemented with isometric resistance exercise, targeting 150 minutes per week and delivered over 24-weeks. Phase 1: one supervised weekly sessions and home-based sessions (eight weeks). Phase 2: home-based sessions (16 weeks). To detect a clinically important BP reduction of 5 mmHg between groups requires 128 patients (two sample t-test, alpha 0.05, beta 0.2, common standard deviation of 10 mmHg). Assuming 20% dropout requires 160 patients. For the primary outcome, the investigators will use a mixed linear regression model in which BP is regressed on group, baseline SBP and eGFR, and time point. Expected outcomes: The findings from this study will address a significant knowledge gap in hypertension management in CKD, inform care-delivery and the design of a larger study on CKD progression. This proposal aligns with priorities for both patients and decision makers: to identify the role of exercise in CKD management and to reshape the delivery of renal care so that it is more consistent with patient values and preferences.
Background: Patient with stage 3 or 4 chronic kidney disease (CKD) usually has normal level of serum phosphate, due to increased serum fibroblast growth factor-23 (FGF23) level that resulted in increased phosphate urine excretion. On the other hand, serum FGF23 elevation was related to CKD progression, vascular calcification, cardiomegaly, and mortality. This double blind, randomized controlled trial study was conducted to evaluate effectiveness and safety of calcium carbonate administration in stage 3 or 4 CKD patients with normophosphatemia. Hypothesis: Calcium carbonate administration is effective and safe in chronic kidney disease (CKD) with normophosphatemia.