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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT01951248 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea

Central and Peripheral 24-h Blood Pressure Before and After 3 Month of CPAP Treatment in Obstructive Sleep Apnea

NOSI
Start date: December 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of 3 months of continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) in moderate to severe cases in patients with chronic kidney disease. The effect is evaluated on blood pressure levels, particularly nocturnal blood pressure, both central and peripheral, and renal function, including the kidneys treatment of salt and water. Hypothesis: 1. Central 24-h blood pressure measuring is a reveals fluctuations in blood pressure during the day more accurately than peripheral 24-h blood pressure measuring because the measurement is painless and does not interfere with the patient activities during the daytime or nighttime sleep. 2. Central blood pressure is elevated in patients with OSA and falls during treatment with CPAP. 3. The renal tubular function relating to the treatment of water and sodium is abnormal in patients with OSA with increased tubular absorption of water via the U-aquaporin 2 (u-AQP2) and of sodium by epithelial sodium channel (ENAC) and is normalized during treatment with CPAP. 4 Quality of life is improved during treatment with CPAP.

NCT ID: NCT01951196 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea

Nocturnal Blood Pressure - Central and Peripheral 24-h Blood Pressure in Chronic Kidney Disease.

NOSA
Start date: October 2013
Phase: N/A
Study type: Observational

A new study have shown that high nighttime blood pressure (BP) and/or non-dipping (lack of fall in blood pressure during nighttime) is a strong predictor for the risk of cardiovascular disease and mortality in patients with hypertension. Three factors seem to affect the night time blood pressure: chronic kidney disease, obstructive sleep apnea (OSA) or the way ambulatory blood pressure is monitored. The aim of this study is to analyse the importance of these three factors on nighttime bloodpressure. Hypothesis: Central 24 hour blood pressure monitoring provides another measure of daily fluctuations in blood pressure than peripheral 24 hour blood pressure monitoring, because measurement is painless and does not interfere with activities during the daytime or night-time sleep In chronic kidney disease and OSA the decrease in nocturnal BP is lower than in healthy subjects. In chronic kidney disease the decrease in the nocturnal BP is inversely correlated to the severity of OSA, the severity of kidney disease, and blood pressure during daytime.

NCT ID: NCT01950819 Completed - Hemodialysis Clinical Trials

Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)

TRANSFORM
Start date: December 3, 2013
Phase: Phase 4
Study type: Interventional

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.

NCT ID: NCT01949532 Completed - Clinical trials for End-stage Renal Disease

Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Multiple Myeloma and Renal Disease

Start date: January 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see how the body and the cancer react to carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with normal kidney function and those with end-stage renal disease to see if they respond differently to the study drug.

NCT ID: NCT01946841 Withdrawn - Quality of Life Clinical Trials

Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life

AL-EN-PHED
Start date: August 2013
Phase: Phase 2
Study type: Interventional

The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.

NCT ID: NCT01942460 Completed - Inflammation Clinical Trials

Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients

Start date: September 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the efficacy of ferumoxytol for the repletion of iron stores and correction of iron deficiency anaemia in patients with severe chronic kidney disease or end-stage chronic kidney disease on peritoneal dialysis, and to assess the impact of the administration of a ferumoxytol dose on various markers for iron stores, as well as on various markers for inflammation and oxidative stress.

NCT ID: NCT01940484 Completed - Anemia Clinical Trials

An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage V Chronic Kidney Disease Patients on Haemodialysis

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

This observational study will evaluate the efficacy and use of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with Stage V chronic kidney disease on haemodialysis receiving an erythropoietin prior to study entry. Attending physicians should have made the decision of placing the patient on Mircera in advance and not related to the study. The therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site. Eligible patients will be followed for 6 months.

NCT ID: NCT01933412 Active, not recruiting - Clinical trials for Chronic Kidney Disease

Efficacy and Safety of Hepatitis B Vaccine in Chronic Kidney Disease Patients

Start date: March 2012
Phase: Phase 3
Study type: Interventional

This is an open label clinical study designed to evaluate the safety and immunogenicity of Sci-B-Vac Hepatitis B Vaccine compared to Engerix-B Hepatitis B Vaccine in dialysis patients. The study hypothesis is that vaccination with Sci B Vac will achieve a higher seroprotection rate and a higher anti-Hepatitis B surface antibody serum titer level than vaccination with Engerix-B Dialysis patients will be categorized as "naïve" or "previously vaccinated" and each group will be randomized to treatment. Naïve patients randomized to Sci-B-Vac Hepatitis B vaccine will receive vaccination in three doses, 10 μg each, at 0, 1, and 6 months, or Engerix-B Hepatitis B vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months. Previously vaccinated patients randomized to Sci-B-Vac Hepatitis B vaccine will receive vaccination in three doses, 20 μg each, at 0, 1, and 6 months, or Engerix-B Hepatitis B vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months. All vaccines will be administered via intra-muscular injection to the deltoid muscle. The study will consist of three periods: a screening period of up to four weeks, a 24-week open-label treatment period, and a 24-week safety follow-up period. The total expected duration of the study per subject is 52 weeks as follows: Screening period: approximately 4 weeks; treatment period: 24 weeks; and follow up period: 24 weeks. The primary endpoint is the by-vaccine difference in the proportion of subjects attaining seroprotective immune response (anti-Hepatitis B surface antibody ≥ 10 IU/mL) 4 weeks after the last vaccination with either Sci-B-Vac or Engerix-B. Secondary endpoints include anti-Hepatitis B surface antibody geometric mean concentrations calculated for all subjects upon last active dose; the proportion of subjects with anti-Hepatitis B surface antibody concentrations equal to or above 10 IU/mL for all subjects at 12 weeks following the first vaccine dose; the by-treatment difference in serum titer levels of anti-Hepatitis B surface antibodies at 12, 24 and 52 weeks following the first vaccination. A by-vaccine comparison of adverse events will also be performed.

NCT ID: NCT01932268 Completed - Clinical trials for Chronic Kidney Disease

A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin

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

The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin.

NCT ID: NCT01932008 Completed - Clinical trials for Chronic Kidney Disease

Evaluation of the Bone Mineral Density and Muscle Mass in Patients Post Coronary Artery Bypass Graft Surgery With Chronic Kidney Disease

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

The purposes of this study are: (1) to compare the body composition, physical activity, physical function, and quality of life between patients with and without CKD after CABG; and (2) to analyze the relationships among body composition, physical activity, and physical function in this population. It is expected that patients after CABG with CKD have the worse body composition, physical function, and quality of life than patients after CABG without CKD; and patients with higher physical activity levels have the better body composition, physical function, and quality of life.