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Clinical Trial Details

Trial ID: L0509
Source ID: NCT00745589
Associated Drug: Sevelamer Hydrochloride
Title: Sevelamer Hydrochloride in Peritoneal Dialysis Patients
Acronym: SERENE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Endstage Renal Disease
Interventions: DRUG: sevelamer hydrochloride
Outcome Measures: Primary: Changes in coronary artery, aortic valve, mitral annulus calcium scores, Vascular and valvular calcium scores, over 24 months | Secondary: Changes in aortic pulse wave velocity, arterial stiffness parameter, over 24 months|annualized percentage change in Coronary artery calcium score, annualized percentage change in calcium score, over 12 months|Changess in serum T50, serum calcification propensity measure, over 24 months|Changes in serum calcium, phosphate, biochemical parameters, over 24 months|Changes in alkaline phosphatase, biochemical parameters, over 24 months|Changes in intact parathyroid hormone, biochemical parameters, over 24 months|Changes in low density lipoprotein-cholesterol, biochemical parameters, over 24 months|Changes in C-reactive protein, biochemical parameters, over 24 months|Changes in systolic blood pressure, blood pressure, over 24 months|Changes in diastolic blood pressure, blood pressure, over 24 months|Changes in Forearm, femur and spine bone mineral density, T score and Z score, Bone mineral density related parameters, over 24 months
Sponsor/Collaborators: Sponsor: The University of Hong Kong
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-07
Completion Date: 2015-01
Results First Posted:
Last Update Posted: 2020-06-18
Locations: Queen Mary Hospital, Tung Wah Hospital, Hong Kong, 0000, Hong Kong
URL: https://clinicaltrials.gov/show/NCT00745589