A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21,...
Chronic Kidney Disease Requiring Chronic DialysisThis is a Phase 3, randomised, active controlled, multicentre extension study to investigate the long-term safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A (NCT01324128), subjects have already been enrolled and have been treated with study medication for at least 24 weeks.
Omega-3 Fatty Acid Supplementation in Children
Chronic Kidney DiseaseHypertriglyceridemiaChildren with Chronic Kidney Disease (CKD) are at very high risk for cardiovascular morbidity and mortality. Hyper-lipidemia, a traditional risk factor for Cardiovascular Disease (CVD), occurs early in the progression of kidney failure; timely identification and intervention is prudent. Currently, there is no known effective therapy for hypertriglyceridemia, the most common lipid abnormality. n-3FA, in doses ranging from 2-6 g/day have effectively lowered elevated triglyceride (TG) levels by 20-50% in a variety of adult populations; however, their use in children with CKD has not been tested in a randomized controlled fashion. This study will provide important information on the safety, efficacy and tolerance of n-3FA in lowering elevated TG levels in children and adolescents with CKD.
Pilot Study of Velcade® in IgA Nephropathy
Chronic Kidney DiseaseIgA NephropathyThe primary objective of this study is to investigate the ability of Velcade® (bortezomib) to induce complete or partial remission in patients with severe IgA nephropathy. The secondary objectives are to assess clinical outcomes relating to safety and efficacy, such as infection, malignancy, preservation of renal function, partial responders, relapse rate, and to study mechanistic assays to predict remission.
Aliskiren Combined With Losartan in Proteinuric, Non-diabetic Chronic Kidney Disease
Kidney DiseaseStudy objective: To investigate the potential anti-proteinuric and renoprotective efficacy of aliskiren in addition to losartan in patients at risk of developing end-stage renal disease (ESRD) Methods: This will be a randomized, double-blind study in which proteinuric, non-diabetic patients with chronic kidney disease (CKD) will be assigned in a 1:1 ratio to one of the following treatment groups for 3 years: Group A: Losartan (Control arm: conventional treatment)* Group B: Aliskiren plus Losartan (Intervention arm)* With optional addition of other anti-hypertensive agents to achieve an optimal target blood pressure of <130/80 mmHg.
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease
Kidney FailureKidney DiseasesMuscle wasting is common in advanced chronic kidney disease (CKD) and adversely affects morbidity and mortality. In 2/3 of males with advanced CKD serum testosterone (TT) levels are reduced, and likely contributes to the wasting. As TT in relatively safe physiologic replacement doses, increases muscle mass in otherwise normal TT deficient subjects, we hypothesize that physiologic TT replacement will be effective in preventing and treating the loss of muscle mass and function in CKD patients, will improve quality of life and may reduce some cardiovascular disease (CVD) risk factors.
Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving...
AnemiaChronic Renal Failure1 moreThe purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any treatment to increase their red blood cell production.
Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease...
Chronic Kidney DiseaseThe primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. This study incorporates a Washout Period and two treatment periods - an active comparison phase and a placebo-controlled withdrawal phase.
Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With...
Chronic Kidney DiseaseMultivessel Coronary Artery DiseasePercutaneous coronary intervention (PCI) with bare metal stent (BMS) in patients with renal insufficiency has shown unsatisfactory results. Indeed, drug-eluting stents (DES) might reduce the incidence of restenosis and therefore of target lesion revascularization procedures in these patients. We therefore designed a prospective, randomized, multicenter, not-sponsored study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (Xience V) and bare-metal stent (Vision) (both 2nd-generation DES and BMS, respectively), both implanted in the same patient with multivessel disease and renal insufficiency in order to obviate for the multiple and unpredictable characteristics of this high-risk population.
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD)...
Secondary HyperparathyroidismChronic Kidney DiseaseSecondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. This study will randomize patients with SHPT and stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of SHPT treatment.
Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment...
Essential HypertensionCardiovascular Disease2 moreThe HYGIA study was designed to investigate prospectively the prognostic value of ambulatory blood pressure (BP) monitoring among subjects primarily evaluated at primary care settings the impact of changes in ambulatory BP during follow-up in cardiovascular, cerebrovascular, metabolic, and renal risk in hypertensive patients the influence of circadian time of treatment in cardiovascular, cerebrovascular, metabolic, and renal risk in hypertensive patients the prevalence of an altered BP profile as a function of antihypertensive treatment, circadian time of treatment, age, and presence of diabetes, among other factors.