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Clinical Trial Details

Trial ID: L1273
Source ID: NCT01315314
Associated Drug: Balance, Fresenius Medical Care, Germany
Title: Effect of Glucose Degradation Products (GDP) on Endothelial Dysfunction
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic|Disorders Associated With Peritoneal Dialysis
Interventions: DRUG: Balance, Fresenius Medical Care, Germany
Outcome Measures: Primary: Inflammation-endothelial-dysfunction index (IEDI), Inflammation-endothelial-dysfunction index (IEDI) is a composite score derived from measurement of serum levels of CRP (high sensitivity assay), soluble VCAM-1 and soluble ICAM-1. Changes between the groups will be tested by analysis of covariance (ANCOVA) with baseline values as covariates. Serial data will also be analyzed using a linear mixed model., Baseline and 12 months | Secondary: Individual component markers of IEDI, individual component markers of the IEDI including sICAM-1, sVCAM-1, and hs-CRP, Baseline and 12 months|RRF, residual renal function (RRF) as average of urea and creatinine clearances by 24 hour urine collection, Baseline and 12 months|peritoneal clearance, peritoneal clearance as weekly Kt/V urea and creatinine clearance, Baseline and 12 months|peritoneal ultrafiltration, peritoneal ultrafiltration volume, Baseline and 12 months|peritoneal transport status, dialysate-to-plasma ratio of creatinine at 4 hours of peritoneal equilibration test, Baseline and 12 months|serum albumin, Baseline and 12 months|LBM, lean body mass (LBM) estimated from creatinine kinetics, Baseline and 12 months|nPNA, normalized protein equivalent of nitrogen appearance (nPNA), Baseline and 12 months|SGA, subjective global assessment (SGA) with a four item and seven-point scale, Baseline and 12 months|Blood pressure, systolic and diastolic blood pressure, Baseline and 12 months|use of antihypertensive medications, number of antihypertensive medications, Baseline and 12 months|peritonitis rates, peritonitis rates, 12 months|technique survival, technique survival by Kaplan-Meier survival analysis with Log-Rank test., 12months|patient survival, patient survival by Kaplan-Meier survival analysis with Log-Rank test., 12 months
Sponsor/Collaborators: Sponsor: Kyungpook National University Hospital | Collaborators: Ministry of Health & Welfare, Korea|Fresenius Medical Care Korea
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 146
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2005-10
Completion Date: 2008-04
Results First Posted:
Last Update Posted: 2011-03-17
Locations: Division of Nephrology and Department of Internal Medicine, Kyungpook National University Hospital, Daegu, 700-721, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT01315314