An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical...
Kidney DiseaseChronicThis national study was a post-marketing surveillance study conducted in Korea from 29 August 2008 to 28 August 2012 to meet local regulatory requirements for Mircera (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated for safety/risk assessments and effectiveness. No specific study-related procedures are required. Participants were to be followed up as long as possible at the physician's discretion.
Assessment of Plasma and NGAL for the Early Prediction of Acute Kidney Injury After Cardiac Surgery...
Acute Kidney Injury (AKI)Chronic Kidney Disease (CKD)6 moreThe study aims to recruit 156 (54 Acute Kidney Injury (AKI);102 non-AKI) patients undergoing Cardio pulmonary bypass (CPB) surgery, including those with Chronic Kidney Disease (CKD) and multiple co-morbidities. Urine and blood samples collected pre-operatively and then 0, 3, 6 and 18 hours post-CPB will be stored at -80oC until batch analysed for NGAL using the Abbott and BioPorto assays. AKI - defined as a ≥50% rise in serum creatinine (SCr) over baseline, or the requirement for renal replacement therapy (RRT). SCr will be measured pre-operatively (baseline), then 12 hourly for the first 48 hrs post-CPB and thereafter 24 hourly for 5 days. Clinical data collected will include patient demographics, co-morbidities, drug history, pre-operative renal function, surgery details (type, length, CPB time etc.), length of Intensive treatment unit and hospital stay and post-operative complications. Data will then be analysed comparing the two NGAL tests to find out which is superior, whether it is better to use blood or urine and to define optimal NGAL cut-offs and sample timing for predicting AKI. Both the Abbott and BioPorto assays will subject to a laboratory method evaluation prior to the analysis of any patient specimens in order to verify that their performance is acceptable and meets the manufacturer's claims. This will involve measuring the standard parameters used to assess laboratory assay performance e.g. imprecision (reproducibility), linearity, recovery and method comparison etc.
Post-marketing Surveillance of Bixalomer in Patients With Pre-dialysis Chronic Kidney Disease
Chronic Kidney DiseaseThe objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.
Barriers to Peritoneal Dialysis Selection
Chronic Kidney DiseaseThe purpose of this study is to understand what prevents chronic kidney disease patients from making a timely decision about dialysis modality options. This understanding will allow us to develop and implement interventions to assist patients in this turning point so that they can make the right decision for them in a timely enough manner so that each patient can start dialysis in the safest and best way for them. 200 later stage chronic kidney disease patients (20% or less of kidney function remaining) will be asked to participate in the study with the goal of having 150 patients participate in the study. Hypotheses: 50 % of patients will have made a modality decision when interviewed and patients in the action stage of behavior will be more likely to make a modality selection than patients in earlier stages of behavior change. Barriers to modality selection will act at several levels including patient, provider and health system level and will vary by behavioral stage of change 10-15% of patients might choose home dialysis. Knowledge, self efficacy in terms of CKD, education, and income will likely be barriers to home dialysis choice.
ADMA Levels in End-Stage Renal Disease
Chronic Kidney DiseaseHypertensionAsymmetric dimethylarginine, ADMA, in plasma, is significantly elevated in patients with renal disease and associated with cardiovascular morbidity and mortality. We found that whole blood (WB) possesses the metabolic pathways required for both the generation and elimination of ADMA and we have developed ex vivo methods to assess the WB accumulation of ADMA in humans. The over-arching hypothesis is that dysregulation of ADMA metabolic pathways leads to greater ADMA whole blood content and greater capacity to accumulate ADMA, which 1) is not reflected by plasma levels and 2) is a better predictor of cardiovascular outcome than plasma levels in end-stage renal disease (ESRD). The following specific aims will be pursued to characterize whole blood ADMA in ESRD: Compare and contrast baseline free plasma ADMA and total whole blood (free plus protein-incorporated) ADMA concentrations in ESRD patients, matched hypertensive controls and a normal population. Determine the capacity of WB to accumulate (the net balance of generation and elimination) ADMA in ESRD patients, matched hypertensive controls and a normal population. We will use state-of-the-art, high performance liquid chromatography techniques to measure ADMA levels in plasma and whole blood. Samples for ADMA measurements will be obtained from subjects with end-stage renal disease immediately before their dialysis treatments. Samples will also be obtained from volunteers without kidney disease. This group will be matched to the end-stage renal volunteers by age, gender and ethnicity. These volunteers will also be matched for the presence of hypertension and diabetes. The third group will consist of a normal population to measure the normal levels of ADMA and compare to the other two groups. There is growing evidence to support a pathological role of ADMA in humans. These experiments will enhance our understanding of how ADMA is processed in the human body and how it is associated with kidney disease. Potentially, these results will lay the groundwork for new insights into the link between ADMA and the high cardiovascular disease burden in patients with kidney disease.
Prevalence of Proteinuria and Chronic Kidney Disease in Pediatric HIV-Infected Patients
Chronic Kidney FailureAIDS-Associated Nephropathy1 moreAmong adults with Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS), Chronic Kidney Disease (CKD) has previously been reported to occur in approximately 10% of children with HIV-infection. The frequency of CKD, its causes, and its natural history in children and adolescents with HIV-infection have not been systematically studied, particularly in the era of new anti-retroviral medications. The primary aim of this study is to determine the how common pediatric HIV-infected individuals have evidence of persistent proteinuria and CKD.
A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making
Congestive Heart FailureChronic Obstructive Pulmonary Disease4 moreThe goal of this research agenda is to improve the quality of end-of-life care by explicitly identifying values that will guide the decision-making process, with a particular emphasis on the role of ethnic, racial and cultural factors.
Study of South African Dialysis Patients
Chronic Kidney DiseaseReceiving DialysisAn observational study to describe the treatment of anaemia in patients with chronic kidney disease, who are receiving dialysis treatment at selected study centres in South Africa.
Observation of the Immune Response After COVID-19 Additional Vaccine Doses in Chronic Patients in...
Chronic Kidney DiseasesCOVID-191 moreObservation of humoral and cellular immune response after additional dose vaccine with different COVID-19 vaccines in ESKD patients in hemodialysis therapy.
Warfarin Versus Aspirin in Patients With Atrial Fibrillation and Chronic Kidney Disease
Atrial FibrillationChronic Kidney DiseaseIn this study, the investigators examine whether aspirin or warfarin is useful for atrial fibrillation patients with chronic kidney disease.