A Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the...
AnemiaThis 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With...
Iron Deficiency AnemiaStudy evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).
External Ionizing Radiation to Prevent Restenosis on Haemodialysis Vascular Access
Renal InsufficiencyChronic4 moreAlthough ionizing radiations have been proposed for the prevention of intimal hyperplasia in coronary and peripheral arteries, information is lacking on how irradiation may prevent neointimal smooth-muscle cell proliferation and restenosis on prosthetic haemodialysis vascular access. We will assess the preventive effect of one dose of radiations (14 Gy) administered transcutaneously one day after dilatation of stenosis on prosthetic haemodialysis vascular access in a randomized controlled trial with a standardized clinical and ultrasonographic one-year follow-up.
ODYSSEE-vCHAT Mental Health Program for Heart Failure and Kidney Disease Patients
Chronic Heart FailureChronic Kidney DiseasesINTRODUCTION Psychological distress and reduced quality of life are prevalent in patients with chronic heart failure (CHF) and advanced chronic kidney disease (CKD). In addition, persons with CHF or CKD live with increased risk of primary or secondary complications associated with COVID-19, including mortality. International task force committees report that medical therapy combined with counselling for CHF and CKD self-care optimizes clinical outcomes. Digital health initiatives present an effective solution in light of the recent issue of declining patient attendance in essential outpatient appointments due to the increased risk of COVID-19 exposure. HYPOTHESES At study completion (up to 16 months), it is hypothesized that there will be a significant increase from baseline in the proportion of participants with clinically improved or sustained positive mental health. Additionally, greater engagement with the ODYSSEE-vCHAT program is expected to be linked with improved self-reported health- and wellbeing-related outcomes at months 4 and 8 and study completion (up to 16 months). RECRUITMENT Patients with CHF or CKD who are at least 18 years old were recruited from the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, The Ottawa Hospital, and the community. Accrual of the sample (N = 215) occurred over a 14-month period. DESIGN This is a single group, open label, pre-post study with assessments at baseline, months 4 and 8, and study completion (up to 16 months). ODYSSEE-vCHAT contacted subjects each week inviting them to participate or partake in digital counselling resources, chatrooms, and presentations with group discussions. Participation in supplemental mental health programs was monitored by self-report. ANALYSES A binomial logistic regression will evaluate if there is a greater proportion of participants with positive mental health at study completion. This analysis will assess if the proportion of participants with positive mental health at study completion (up to 16 months) is independently associated with ODYSSEE-vCHAT engagement (login minutes). General linear models will test secondary outcomes, adjusting for baseline assessments and potential covariates. Significance in all tests will be p < 0.05, 2-sided. Any unplanned analyses will be adjusted for using the Bonferroni procedure.
National Unified Renal Translation Research Enterprise - Chronic Kidney Disease
Chronic Kidney DiseasesChronic Kidney Disease (CKD) affects around 10% of the adult population and is associated with an increased risk of heart attack, stroke and end stage kidney disease (ESKD). This study aims to better predict who is most likely to progress to ESKD using previously identified risk factors and novel biomarkers in blood and urine samples, along with kidney biopsy tissue. Resources can then be directed to those most at risk of disease progression and other associated conditions such as heart attack and stroke, while those at lower risk can be offered less frequent monitoring.
Clinical Efficacy of Two Erythropoietin Drug in Participants With Secondary Anemia to Chronic Kidney...
Chronic Kidney DiseaseAnemiaThis is a prospective, randomized, multicenter, parallel, placebo-controlled, phase III study for evaluation of clinical efficacy and immunogenicity of drug Eritromax® - (rHuEPO Blau Farmacêutica S/A.) compared to Eprex® (Janssen-Cilag rHuEPO) for the treatment of patients with secondary anemia to chronic kidney disease (CKD), throughout the correction phase by assessing the change in hemoglobin levels.
PD-HF: A Trial of Peritoneal Dialysis in Patients With Severe Heart Failure and Chronic Kidney Disease...
Heart FailureChronic Kidney DiseaseThis trial is to establish whether ultrafiltration by peritoneal dialysis is a clinically effective treatment for patients with severe heart failure and moderate chronic kidney disease, thus improving quality of life and symptoms.
Effect of Epinephrine on Systemic Absorption of Mepivacaine in Uremic Patients
Renal InsufficiencyChronicThe aim of this study is to determine the effect of epinephrine on systemic absorption of local anaesthetic mepivacaine administered for brachial plexus block in uremic patients scheduled for creation or repair of an arteriovenous fistula. Furthermore, an impact of epinephrine on the central circulation and peripheral tissue oxygenation will be evaluated.
A Glomerular Filtration Rate (GFR) Measuring Study of RTA 402 in Chronic Kidney Disease (CKD) Patients...
Chronic Kidney DiseaseType 2 DiabetesA Phase 2 glomerular filtration rate (GFR) measuring study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.
Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor...
AnaemiaDaprodustat has demonstrated an ability to effectively raise hemoglobin concentrations with lower erythropoietin (EPO) levels than those observed after administration of recombinant human erythropoietin (rhEPOs). Therefore, daprodustat has the potential to treat anemia of chronic kidney disease (CKD) with a lower cardiovascular (CV) risk than is observed with the rhEPOs. While the effect of rhEPOs on endothelial function has been assessed, to date the effect of daprodustat or other prolyl hydroxylase inhibitor (PHI) compounds on endothelial function has not. Therefore, the purpose of this study is to compare the effect of daprodustat to darbepoetin alfa on endothelial function by assessing FBF in participants with anemia of CKD by using venous occlusion plethysmography as a means to estimate the potential for daprodustat to have a lower risk of CV events as compared to rhEPO. This study will use a randomized, repeat dose, open label, parallel group design, in adult, not on-dialysis, male and female participants with anemia of CKD that are currently not treated with rhEPOs. The study will comprise of three study periods: a screening period starting up to 30 days prior to Day 1, a 42 day (6 week) treatment period, and a follow-up visit up to 14 days later. The total duration of participants involvement is up to 14 weeks (including screening and follow up visit). Approximately 50 participants will be randomized to either daprodustat or darbepoetin alfa.