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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT01865526 Completed - Clinical trials for Chronic Kidney Disease

Efficacy of the 6-point Diet

PIS
Start date: March 2010
Phase: N/A
Study type: Interventional

The dietary restriction of proteins and sodium is a cornerstone in the treatment of chronic kidney disease (CKD) and of its metabolic consequences. Dietary adjustments in CKD are complex and the patients' compliance is very low. A dietary interview method is a validated instrument to evaluate the patients' compliance; however, it the presence of a dedicated dietitians. For these reasons, and because of the absence of dedicated dietitians in many nephrology centres, it is usual practice to give standard low protein diets to CKD patients not on dialysis. Aim of this study was to verify if few simple tips were able to reduce protein, phosphate and sodium intake in patients with CKD, as compared to the practice of giving a low protein diet elaborated by a renal dietitian.

NCT ID: NCT01864161 Completed - Clinical trials for Chronic Kidney Disease

Endovenous Versus Liposomal Iron in CKD

Start date: October 2011
Phase: Phase 4
Study type: Interventional

Anemia is a common complication in patients with chronic kidney disease (CKD). In addition to erythropoietin deficiency, many studies have identified iron deficiency as a cause of anemia in CKD patients. Most patients with CKD are iron deficient because of: inadequate intake and absorption, gastroenteric bleeding, urinary iron loss in patient with significant proteinuria. The iron treatment is pivotal to manage anemic patients with CKD: the prescription of iron is usually oral because of practicality and safety, but often it is inevitable to administer intravenous iron because of gastroenteric malabsorption, intolerance to oral administration, irregular intake. There're few randomized controlled studies about the efficacy of oral iron versus intravenous iron in patients not on dialysis; most of them demonstrate superiority of intravenous therapy to restore iron deficiency and hemoglobin levels. A particular formulation of iron, liposomal iron has a high gastroenteric absorption and high bioavailability with lower incidence of side effects. The investigators study aims to evaluate the efficacy of treatment with liposomal oral iron compared to intravenous iron in CKD anemic patients not on dialysis in the presence of iron deficiency.

NCT ID: NCT01862679 Completed - Clinical trials for End Stage Renal Disease

Randomised Study of High-flux Haemodialysis and Haemodiafiltration

Start date: July 2013
Phase: N/A
Study type: Interventional

The most common forms of renal replacement therapy currently in use are high flux haemodialysis (HF-HD) and haemodiafiltration (HDF). Although these techniques appear similar to the patient, there are important differences in what happens to the blood as it travels through the dialysis machine. During HDF, the machine controls hydrostatic pressure across the dialyser to remove additional water together with toxins from the blood and this fluid volume is continually replaced with an ultra-pure solution. HDF has a theoretical advantage removing more waste substances, especially larger molecules, from the blood than HF-HD which may be of benefit to the patient in the medium to long term.Despite the theoretical advantages, trials have so far been unable to find any significant difference in death rates or the development of health problems among patients on HDF or HF-HD. It is therefore important to examine other factors which may help doctors and patients to decide which treatment to use. The investigators have designed a study which aims to answer three main questions: 1. Does HDF make patients feel better? 2. Is blood pressure more stable on HDF in comparison with HF-HD? 3. Are Phosphate levels and other blood parameters better controlled with HDF than HF-HD? The investigators will do this by randomly assigning patients on HF-HD to receive 2 months of either HF-HD or HDF with as equivalent treatment prescriptions as possible and without the patient knowing which treatment they are receiving. After two months the patients will switch to the alternative form of dialysis for a further two months. During the study the investigators will ask the patients how long it took them to recover from the preceding session of dialysis, assess the frequency of symptomatic low blood pressure and also perform blood tests at set intervals to measure specific blood parameters.

NCT ID: NCT01857024 Completed - Clinical trials for Chronic Kidney Disease

Post Authorisation Safety Study of Renvela® in Chronic Kidney Disease Patients Not on Dialysis With Hyperphosphataemia

Start date: September 2010
Phase: N/A
Study type: Observational

The primary objective of this study is to assess in a post-approval clinical setting the safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of Product Characteristics (SmPC) and followed according to the investigator's standard clinical practice management. Each patient will be followed up for 12 months or up to the time they start dialysis, whichever occurs first.

NCT ID: NCT01855295 Completed - Clinical trials for End Stage Renal Disease

Protein Supplementation in Dialysis Patients

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

Poor nutritional status as evidenced by low body mass index, low muscle mass or low serum albumin is a strong predictor of morbidity and mortality in dialysis patients. Hypercatabolism induced by inflammation is widely considered the cause of uremic malnutrition even though there is no clear evidence that hemodialysis patients with elevated C-reactive protein (CRP) levels are at greater risk of losing weight or muscle mass. Conversely, there is little data on whether dialysis patients with malnutrition and elevated C-reactive protein levels would gain muscle mass with protein supplementation. The hypothesis is that protein supplementation during dialysis will improve muscle mass, functional status and quality of life in inflamed malnourished hemodialysis patients. Therefore, the objectives of the current proposal are to examine in malnourished (body mass index < 23 kg/m2 or serum creatinine < 8 mg/dL) hemodialysis patients with inflammation (high sensitivity CRP > 3 mg/dL), the effects of protein supplementation on 1. Muscle mass as determined by creatinine kinetics 2. Functional status as assessed by 6 min walk 3. Quality of life as assessed by Short Form -12 survey

NCT ID: NCT01850901 Completed - Hypertension Clinical Trials

Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension

SYMPATHY
Start date: May 2013
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess whether renal denervation (RD) added to usual care compared to usual care alone reduces blood pressure (BP) as determined with ambulatory BP monitoring (ABPM) after 6 months in subjects with an average day-time systolic BP of at least 135 mmHg as determined with use of ABPM, despite use of three or more BP lowering agents or with documented intolerance or contraindication for to 2 or more of the 4 major classes of antihypertensive drugs (ACEi/ARB, calcium channel blockers, betablockers and diuretics) obstructing use of 3 antihypertensives Further aims are to assess the effect of renal denervation on the use of BP lowering agents, to explore the effect of renal denervation in strata of estimated glomerular filtration rate (eGFR) (eGFR 20-60 mL/min per 1.73m2 and eGFR>60 mL/min per 1.73m2) and according to baseline office BP. Randomization will be stratified by hospital and eGFR and will be at a 2:1 ratio.

NCT ID: NCT01847092 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

Start date: May 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.

NCT ID: NCT01846468 Completed - Clinical trials for Chronic Renal Insufficiency

An Ascending Dose Study to Assess Safety, Tolerability, PK/PD of LHW090 in Healthy Volunteers and in Subjects With Renal Dysfunction

Start date: March 1, 2013
Phase: Phase 1
Study type: Interventional

The purpose of the study is to provide pertinent information to enable decisions regarding the developability of LHW090 for use in patients with chronic renal insufficiency, including a comparison of the potential risk-benefit ratio of several doses of the study drug to enable optimal doses to be tested in later studies.

NCT ID: NCT01845402 Completed - Clinical trials for Chronic Kidney Failure

Chronic Kidney Disease in Teenagers With Congenital Cardiac Disease

PRECARDIO
Start date: April 2, 2013
Phase: N/A
Study type: Observational

The prevalence of chronic kidney injury (CKD) following cardiac surgery during childhood is not known, but there is evidence of CKD in young adults. In the present study assumption is made that CKD can already by diagnosed in patients at or just before adolescence, and the aim is calculate its prevalence according to the KDIGO criteria by a cross-sectional study, which will enroll patients aged 10 to 15 years. The second hypothesis is that events occurring peri-operatively during initial surgery or during follow-up could by chart review and regression analysis.

NCT ID: NCT01844882 Completed - Clinical trials for Chronic Kidney Disease

The Effects of Dietary Fiber in CKD: A Systematic Review and Meta-analysis

Start date: January 2012
Phase: N/A
Study type: Observational

Chronic kidney disease (CKD) is a debilitating condition in which there is a gradual decline of renal function associated with increased overall mortality. Most dietary guidelines for CKD focus on limiting protein intake (nitrogen) and high phosphorus-containing foods. However, increasing dietary fiber has been proposed to increase fecal nitrogen excretion which may ameliorate the progress of CKD. We therefore plan to conduct a systematic review and meta-analysis on clinical trials to assess the effect of fiber on urea and creatinine as classical markers of a state of uremia in individuals with CKD. We hypothesize that increasing fiber intakes will improve urea and creatinine levels in individuals with CKD.