An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis...
Kidney DiseaseChronicThis observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by treating physician and followed for approximately 36 months.
The Effect of Diuretics on Mineral and Bone Disorder in Chronic Kidney Disease Patients
Secondary HyperparathyroidismChronic Kidney DiseaseChronic kidney disease (CKD) patients often have associated systemic hypertension due to volume retention, as one of the mechanisms, therefore the use of diuretics is widespread in this population. One of the major complications of CKD is mineral and bone metabolism disorder (CKD-MBD), which include changes in the levels of calcium, phosphorus, vitamin D deficiency, increased circulating levels of fibroblast growth factor (FGF-23) and parathyroid hormone (PTH). These alterations are responsible for fractures, cardiovascular disease and mortality among patients with CKD. According to diuretic mechanism of action, sometimes increasing serum calcium (in the case of furosemide), sometimes decreasing it (in the case of thiazide), it is expected that the serum calcium may be altered, even within the range of normality, with consequent impact on the levels of PTH. Although most studies have shown that the use of thiazide diuretics decreases the risk of fractures, some showed the opposite. Similarly, although most studies have shown increased risk of fracture in association to loop diuretics use, some have failed in demonstrated this outcome. Only one study, a cohort study in a population of CKD, showed that furosemide was directly related to increased calciuria and PTH levels and the use of thiazide, in turn, showed completely opposite effect. However, certain issues are still not completely solved, for example, the interference of renal function itself on calciuria. It is possible that calciuria is not a so simple explanation that justifies the PTH levels changes, as no correlation was seen between calciuria and PTH levels. Better understanding of the exact relationship between the use of diuretics and the impact on CKD-MBD may be an alternative intervention, easily accessible and relatively inexpensive. The purpose of this study is to evaluate the impact of diuretic, specifically hydrochlorothiazide and furosemide, on bone architecture and mineral metabolism.
Iron Deficiency and FGF23 Regulation in CKD and HF
Chronic Kidney DiseasesChronic Heart Failure1 moreThis study investigates the effects of intravenous (IV) iron sucrose therapy on blood levels of Fibroblast Growth Factor 23 (FGF23, a protein that regulates the amount of phosphate in the body) in iron deficiency anemia in healthy participants, participants with Congestive Heart Failure (CHF, where the heart does not pump adequate blood supply to the body), participants with Chronic Kidney Disease (CKD, where the kidney function is reduced), and participants with CKD and CHF.
Registry to Evaluate Maintenance Treatment With Venofer in Pediatric Patients With Chronic Kidney...
Chronic Kidney DiseaseThe current registry is being undertaken to assess the long-term (12 month) safety and tolerability of Venofer in the pediatric population with chronic kidney disease that requires intravenous iron maintenance therapy.
Observational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous...
CKD (Chronic Kidney Disease) Stage 5TDiabetes Mellitus1 moreA single-centre, prospective, observational study to evaluate the safety and efficacy of Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients.
The Kidney and The Brain Study - Assessment of Cognitive Impairment in Advanced CKD
Cognitive ImpairmentChronic Kidney Diseases5 morePatients with failed kidneys need Renal Replacement Therapy (RRT) to remove fluid and toxins from the body. The 3 types of RRT are kidney transplant or removal of waste by dialysis, either via the blood (haemodialysis) or via the stomach area (peritoneal dialysis). 27,000 patients currently receive dialysis in the UK and some endure reduced quality-of-life, depression, and thinking and memory difficulties. Some of these symptoms reflect undiagnosed dementia. Indeed up to 7/10 dialysis patients suffer moderate to severe brain impairment or dementia - much more frequently than in the general population. This study will assess brain function just before starting dialysis/transplant and at 3 and 12 months afterwards with face to face assessments and with brain scans in some patients. Changes in brain function will be compared between people treated with the different forms of dialysis and transplant. The Investigators hope to evaluate whether these tests are acceptable to patients, whether affected sub-groups with cognitive impairment can be identified early, and if certain dialysis methods are better for patients with cognitive impairment/dementia, so that a larger study to try to improve brain function after RRT can be developed.
SOP's for CKD-MBD-Biomarkers
Chronic Kidney DiseasesCKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) is an extensive disease and includes dysfunction of the mineral metabolism, the bone metabolism and cardiovascular diseases in the context of renal insufficiency. Clinical pictures of peripheral artery occlusive disease (PAOD), Coronary artery disease (CAD) and arterial hypertension favours among other main risk factors (smoking, obesity, etc.) additional cardiovascular complications. For this reason it makes sense to monitor these patients regularly. For this purpose the determination of different biomarkers would be appropriate for control of the course of disease. During various studies the biomarkers FGF23, s-klotho, sclerostin, DKK1, BMP2, YKL-40 und MGP were established as indicators for the disease activity, as diagnostic criteria for the existence of CKD-MBD or as risk markers for the incidence of adverse events (incl. death) within the scope of CKD-MBD. For the clinical routine care application of these parameters standard operating procedures (SOP) are missing for the determination method relating to optimal pre-analytic and analytic procedures. These analyses are necessary to ensure the reproducibility of study results and to transfer these parameters in the clinical daily routine for risk stratification.
Feasibility of Enhanced Dialysis Education (EDU) Intervention for Chronic Kidney Disease (CKD) Patients...
Chronic Kidney DiseasesThe investigators are studying the feasibility, acceptability, and outcomes of an intervention called Enhanced Dialysis Education (EDU) Intervention. CKD-EDU is a palliative care-based dialysis decision-making intervention that involves educating patients and caregivers about dialysis and engaging them in shared decision-making. Half of the enrolled patients will receive CKD-EDU and the other half will receive Usual Care.
Small-fiber Neuropathy in Chronic Kidney Disease
Small-Fiber NeuropathyChronic Kidney DiseaseNeurological dysfunction is a common complication of late stage chronic kidney disease (CKD) and peripheral nerve system is often involved in such complication. Sensory disturbances such as paresthesia and hypoesthesia are the predominant symptoms in uremic polyneuropathy and it is traditionally thought the uremic polyneuropathy mainly involve large-diameter sensory nerves. However in uremic patients the abnormal thermal thresholds, the sensory symptoms like numbness, burning, paradoxical heat, cold or freezing, and pain, and the frequent symptoms of autonomic dysfunction suggest that small-fiber neuropathy should be a clinical entity in patients of CKD. But there are still few investigations with emphasis on the changes of small-fiber nerves in CKD, and little is known about the characteristics and mechanism of small-fiber neuropathy in CKD. Skin biopsy with evaluation of epidermal nerve density and the morphology of epidermal nerves and the subepidermal nerve plexus is an effective and minimally invasive test for assessment of small-fiber neuropathy. Contact heat evoked potential (CHEP) recording the brain responses evoked by contact heat stimuli on the skin is a non-invasive technique to investigate the thermo-nociceptive pathways mediated by small-fiber nerves. In the current study, we will use an integrated approach by combining the skin biopsy, quantitative sensory testing, autonomic function tests, and CHEP to investigate the pathological, psychophysical and physiological aspects of small-fiber neuropathy in patients of CKD. The aims of the current study is to address the following issues: (1) the changes of small fiber nerves in uremia and CKD of different stage; (2) the correlation of skin innervation with clinical manifestations, thermal thresholds, and autonomic function; (3) the influence of dialysis therapy, the type of dialysis therapy, or renal transplantation on the small fiber neuropathy in uremia; (4) the roles of blood chemical substances, metals, and endocrine profiles on the development of small-fiber neuropathy; (5) the relationship between the small-fiber neuropathy and pruritus or restless leg syndrome; and (6) the pathological and physiological correlates of painful symptoms by skin biopsy and CHEP in CKD related neuropathy. The results of the study will provide important insights in the understanding of the pathogenesis, and the prevention and new treatments of small-fiber neuropathy in CKD.
Pharmacokinetic Study in Patients With Chronic Kidney Disease and Healthy Volunteers
Kidney DiseaseThe purpose of this study is to find out how chemicals in the blood of patients with chronic kidney disease affect how medications are removed from the body. The patient will take one dose of three different drugs, one on each week, for a total of three single doses. The investigators want to find out if these three different medications are affected in different ways by the chemicals in the blood of patients with kidney disease.