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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT01364688 Recruiting - Clinical trials for Vascular Calcification

Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

Start date: May 2011
Phase: Phase 2
Study type: Interventional

Active vitamin D at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it.

NCT ID: NCT01364402 Recruiting - Diabetes Clinical Trials

Prevention of Contrast Induced Nephropathy by Erythropoietin

Start date: August 2011
Phase: Phase 3
Study type: Interventional

This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule for primary PCI or elective PCI will randomly allocated to receive either a single dose of EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI. The investigators assume that the incidence rate of CIN will be significantly lower in the EPO group compared to placebo. In addition, EPO administration will result in a decrease of infarct size.

NCT ID: NCT01363336 Completed - Hypertension Clinical Trials

Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease

Start date: November 2009
Phase: N/A
Study type: Observational

This study is a post-marketing surveillance in Japan, and it is a local prospective, company sponsored and observational study of patient who have been treated by Adalat CR for hypertension with diabetes and/or chronic kidney disease. The objective of this study is to assess safety and efficacy profile of using Adalat CR in real clinical practice. A total 2,000 patients will be recruited and be observed for 6 months. Then, patient of whom microalbumin urea and serum creatinine are continuously monitored are additionally followed for 6 months.

NCT ID: NCT01362569 Completed - Acute Renal Failure Clinical Trials

Endotoxin, Neutrophil Function and Albumin in Renal Insufficiency

ENARI
Start date: July 2011
Phase: N/A
Study type: Observational

Chronic kidney disease is widespread in the western world with bacterial infection and sepsis as common complication. It has been shown that innate immune defence, represented by dysfunction of neutrophil granulocytes, is impaired in chronic kidney disease. Another impact of chronic kidney disease on innate immunity is the chronic activation of neutrophils leading to high levels of inflammatory cytokines, thus contributing to protein oxidation. Oxidation of human serum albumin (HSA), the major plasma protein, occurs in chronic kidney disease and leads to further activation of neutrophils. Another important impact of HSA oxidation is the decrease of its binding capacity leading to impaired detoxification ability of albumin. This includes reduced clearance of endotoxin, a major component of the gram negative bacterial cell wall. Circulating endotoxin is recognized by complex formation with lipopolysaccharide binding protein (LBP) followed by binding to CD14 and toll-like receptor (TLR) 4. High systemic endotoxin levels occur in chronic kidney disease and may be the result of decreased clearance ability of HSA and increased gut permeability in combination with intestinal bacterial overgrowth. High systemic endotoxin is associated with worse outcome in several diseases and could be used as predictor for mortality in chronic kidney disease patients. Endotoxemia in renal insufficiency leads to impaired neutrophil function and to increased albumin oxidation. Oxidized albumin is not able to bind endotoxin adequately any more, which leads to a further increase in oxidative stress and neutrophil dysfunction, resulting in a vicious cycle. 195 patients with renal dysfunction will be enrolled and divided into 5 groups. Additionally, samples of 25 age and sex-matched healthy controls will be collected. This concept will change the understanding of several aspects of chronic kidney disease and will potentially help to stratify patients into different groups at risk according to their endotoxin status, and their immune and albumin dysfunction. The results of this study will have important implications into the development of novel therapeutic strategies

NCT ID: NCT01357317 Recruiting - Clinical trials for Chronic Kidney Disease

Study Comparing Effects of Lanthanum Carbonate Versus Calcium Acetate Versus Dietary Phosphorus Restriction

Start date: June 2011
Phase: Phase 3
Study type: Interventional

Objective: To examine the effects of three commonly applied treatments of disordered phosphorus homeostasis on biochemical markers and vascular characteristics in patients with moderate and advanced non-dialysis dependent chronic kidney disease.

NCT ID: NCT01356849 Completed - Clinical trials for Chronic Kidney Disease

Evaluate the Efficacy and Safety of Once Daily Administration of Atrasentan Tablets (Low and High) Compared to Placebo in Reducing Residual Albuminuria in Type 2 Diabetic Patients With Nephropathy Who Are Treated With the Maximum Tolerated Labeled Dose of a Renin Angiotensin System (RAS) Inhibitor

RADAR
Start date: April 2011
Phase: Phase 2
Study type: Interventional

Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study. The objective of the study is to evaluate the efficacy and safety of once daily administration of atrasentan tablets (low dose and high dose) compared to placebo in reducing residual albuminuria in Type 2 diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose of a Renin Angiotensin System (RAS) inhibitor. If the patient is already receiving a maximum tolerated labeled daily dose of RAS inhibitor and a diuretic, he/she will complete 4 weeks of the Run-in Period on a dose that has not been adjusted. If the patient is currently not receiving a maximum labeled daily dose of a RAS inhibitor then the dose will be titrated up to the maximum tolerated labeled dose over the course of 4 to 8 weeks during the Run-in Period. It is expected that subjects not receiving a diuretic will have a diuretic added or titrated during this period to maximize RAS inhibition. Following titration to the maximum tolerated labeled dose, the patient will complete an additional 4 weeks of Run-In Period on an unchanged doses of RAS inhibitor and diuretics, unless medically contraindicated. The randomization will be stratified based on country where subjects are enrolled into the study, and the Week -1 Urinary Albumin to Creatinine Ratio (UACR) levels (< or = 1000 mg/g [113 mg/mmol], or > 1000 mg/g [113 mg/mmol]). Within each stratum, subjects will be randomly assigned in a 1:2:2 ratio to one of the following blinded treatment groups: Group A - Placebo once daily (QD) Group B - low dose atrasentan QD Group C - high dose atrasentan QD After the 12 weeks of study drug treatment, subjects will be followed up to 30 days.

NCT ID: NCT01356394 Completed - Obesity Clinical Trials

Weight Loss Improves Renal Hemodynamics

Start date: January 2010
Phase: Phase 4
Study type: Interventional

Metabolic syndrome (MS) is a clustering of risk factors for cardiovascular disease (CVD) such as hypertension, hypertriglyceridemia, low HDL-cholesterol levels, disorders of glucose metabolism, and insulin resistance. A number of associated conditions are included in the MS spectrum such as abdominal obesity, systemic inflammatory activation, endothelial dysfunction, non-alcoholic fatty liver disease, hyperuricemia, polycystic ovarian syndrome, and microalbuminuria. As a consequence, the diagnosis of MS identifies patients who are at increased risk for type 2 diabetes mellitus and CVD. In the last few years, the potential for MS to trigger renal damage and accelerate the progression of pre-existing nephropathy has become a focus of research. Some studies have suggested that MS can influence the development of CKD, although the underlying mechanisms are not well understood. In this study, the investigators hypothesized that modifying a key component of the MS, namely obesity, could attenuate renal damage. The investigators examined the impact of weight loss on creatinine clearance and urinary albumin excretion in non-diabetic obese patients with MS.

NCT ID: NCT01353417 Completed - Clinical trials for Chronic Kidney Insufficiency

Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection

Start date: April 2011
Phase: N/A
Study type: Observational

This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.

NCT ID: NCT01351675 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes

BEACON
Start date: June 30, 2011
Phase: Phase 3
Study type: Interventional

This study assesses the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care.

NCT ID: NCT01351636 Completed - Clinical trials for Chronic Kidney Disease

Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients

AHOCEP
Start date: April 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to ascertain whether Arotinolol Hydrochloride reduces mortality and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.