Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
Chronic Kidney DiseaseSecondary Hyperparathyroidism2 moreThis study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK) in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis. This study will also investigate the safety and effects of different strengths of CTA018, on parathyroid hormone (PTH) levels.
Study of the Efficacy of Darbepoetin Alfa in the Treatment of Renal Anemia
AnemiaKidney Failure3 moreAnaemia is a common consequence of chronic renal failure. Darbepoetin alfa is a unique erythropoietic protein that stimulates erythropoiesis by the same mechanism as endogenous erythropietin and conventional recombinant human erythropoietin (rHuEPO). Darbepoetin alfa has been shown to have a serum half-life 3-fold longer than that of rHuEPO, which allows dosing at extended intervals and less frequent injection. The objective is to evaluate the efficacy and safety of darbepoetin alfa therapy given at an extended once monthly dosing interval in the treatment of renal anaemia in continuous ambulatory peritoneal dialysis.
Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal...
Chronic Renal FailureChronic Kidney Disease1 moreThe purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.
Cognitive Behavioral Treatment of Depression in ESRD Patients on Dialysis
End Stage Renal DiseaseDepressionDepression is second in frequency only to hypertension as a comorbid condition for End Stage Renal Disease (ESRD) patients. The presence of depression has been linked to lower quality of life, more medical comorbidities and shorter lifespan. This project represents the first known attempt at a standardized intervention for depression in ethnically diverse ESRD patients. The study will be conducted at the Parkside Center for Dialysis. Patients will be randomly selected for screening until 80 subjects meet entry criteria and agree to be randomized. Once subjects are screened and enrolled in the study they are randomly assigned to either a treatment or wait-list control condition. After 3 months, the intervention will be completed and both groups will be reassessed. After an additional 3 months, both groups will have received the intervention and pre and post measures for both groups will be available as well as 3 month follow-up for the 1st intervention group. The following measures will be collected: to obtain a full DSM-IV diagnosis the SCID I and SCID II will be utilized. The BDI will provide a self-report measure of depression. The Hospital Anxiety and Depression Scale (HADS), a measure designed specifically for medically ill patients, will also be administered. Additionally, the Young Schema Questionnaire, a measure which seeks to identify maladaptive (both depressive and anxious) cognitive styles, will be administered. A quality of life measure designed specifically for dialysis patients (KDQOL-SF) will also be given as a means of measuring patient's overall coping and functioning. To better understand the patient's perceptions of their health and illness the Illness Effects Questionnaire will be administered. A demographic information sheet will be completed by the subject in which personal, ethnic, and illness information is collected. Detailed information about the subject's mental health history and treatment as well as current medications will be gathered. Data from routine dialysis laboratories (hemoglobin, creatinine, albumin, Kt/V) will be extracted from the chart. The intervention will take place in individual format while the subjects are being dialyzed. The intervention will be 10 sixty minute -long weekly sessions spread over not more than 3 months. It will include both cognitive and behavioral skills focused on alleviating depressive affect and identifying maladaptive patterns of thought and behavior. This study would lay the groundwork for future clinical research by helping to develop a culturally competent clinical intervention and demonstrate the feasibility and effectiveness of adapting psychosocial intervention for a medically complex culturally diverse population.
Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity...
HemodialysisChronic Renal Failure1 moreThe purpose of this research study was to determine if the activity of erythropoietin (r-HuEPO) is time dependent when given to chronic renal failure patients at three different times of day.
The Effect of CoQ10 Administration on Hemodialysis Patients
Chronic Renal FailureHemodialysisThe purpose of this study is to examine whether CoQ10 administration is effective as an antioxidant in hemodialysis patients.
Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and...
End-Stage Renal DiseaseHemodialysisThe high rate of cardiovascular complications in the dialysis population cannot be explained by traditional cardiovascular risk factors. One of such factors proposed to contribute to the cardiovascular mortality in dialysis patient population is vascular calcification possibly resulting from disturbances of calcium-phosphate metabolism. The aim of this study is to assess the effects of treatment with dialysate containing 1.75 or 1.5 mmol/L to 1.25 mmol/L calcium regarding coronary artery calcification and bone histomorphometry in hemodialysis patients.
Renal Transplantation and Inhaled Anesthetic Sevoflurane (SEVOREIN)
End-stage Chronic Renal DiseaseSevere Acute Kidney Failure1 moreRenal transplantation is characterized by ischemia-reperfusion lesions in allograft. In a previous study, Julier and al. (Anesthesiology 2003) have demonstrated that sevoflurane reduces glomerular lesions in kidney of patients undergoing a cardiovascular surgery and présenting with ischemia-reperfusion phenomena. The purpose of the study is to evaluate the effects of sevoflurane on the recovery of renal graft function in patients after kidney transplantation. This study will be a randomized, double blinded, controlled clinical trial and 120 patients undergoing renal allograft transplantation will be included. Patients will be divided into 2 groups: one group of patients who will receive sevoflurane (evaluated treatment) for anaesthesia and the other one who will receive propofol (reference treatment). We will evaluate renal function for one year after transplantation. Ours results will confirm or not that sevoflurane protects kidney function from ischemia-reperfusion lesions.
Hemocontrol and Blood Pressure Control in Dialysis Patients
End-Stage Renal DiseaseHemodialysisVolume overload contributes significantly to the pathogenesis of hypertension in hemodialysis patients. The Hemocontrol(HC)system (Gambro), which automatically adjusts ultrafiltration rate and dialysate conductivity according to blood volume variations during dialysis, has been suggested to improve hemodynamic tolerance and thus facilitate fluid removal. This randomized controlled trial was designed to compare the use of HC with standard hemodialysis to test the hypothesis that the use of the HC system may lower home blood pressure in comparison with standard hemodialysis as a primary endpoint. Secondary endpoints are a variation in the percentage of dialysis sessions requiring nurses' interventions for intra-dialytic hypotension and a change in the health-related quality of life of HD patients.
EPO-BUL-01 - Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis...
Chronic Renal FailureThe purpose of the study is to evaluate the effectiveness, safety and clinical outcome of Epoetin alfa with dosing regime in accordance with Summary of Product Characteristics in the treatment of anemia in predialysis.