Sevelamer Hydrochloride in Peritoneal Dialysis Patients

Overview

To test the hypothesis that second-line fixed low-dose sevelamer hydrochloride therapy is as effective as first-line high-dose sevelamer hydrochloride therapy in limiting the progression of cardiovascular calcification.

Full Title of Study: “Use of Sevelamer Hydrochloride to Control Hyperphosphatemia and Reduce Calcification Burden in the Poor Peritoneal Dialysis Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

Detailed Description

Cardiovascular disease accounts for nearly 50% of the mortality and is the most frequent cause of hospitalization in ESRD patients. Hyperphosphatemia is increasingly recognized to be an important predictor of mortality and cardiovascular death in ESRD patients and is largely attributed to the increased prevalence of vascular calcification.

Interventions

  • Drug: sevelamer hydrochloride
    • First-line higher dose (that is, 800mg TDS and up to a maximum of 1200mg TDS) sevelamer hydrochloride will be compared against low dose second-line sevelamer hydrochloride (that is, fixed dose of 400mg TDS)

Arms, Groups and Cohorts

  • Active Comparator: higher dose sevelamer
    • first-line higher dose sevelamer hydrochloride
  • Active Comparator: low dose sevelamer
    • second-line fixed low-dose sevelamer hydrochloride added to calcium carbonate

Clinical Trial Outcome Measures

Primary Measures

  • Changes in coronary artery, aortic valve, mitral annulus calcium scores
    • Time Frame: over 24 months
    • Vascular and valvular calcium scores

Secondary Measures

  • Changes in aortic pulse wave velocity
    • Time Frame: over 24 months
    • arterial stiffness parameter
  • annualized percentage change in Coronary artery calcium score
    • Time Frame: over 12 months
    • annualized percentage change in calcium score
  • Changess in serum T50
    • Time Frame: over 24 months
    • serum calcification propensity measure
  • Changes in serum calcium, phosphate
    • Time Frame: over 24 months
    • biochemical parameters
  • Changes in alkaline phosphatase
    • Time Frame: over 24 months
    • biochemical parameters
  • Changes in intact parathyroid hormone
    • Time Frame: over 24 months
    • biochemical parameters
  • Changes in low density lipoprotein-cholesterol
    • Time Frame: over 24 months
    • biochemical parameters
  • Changes in C-reactive protein
    • Time Frame: over 24 months
    • biochemical parameters
  • Changes in systolic blood pressure
    • Time Frame: over 24 months
    • blood pressure
  • Changes in diastolic blood pressure
    • Time Frame: over 24 months
    • blood pressure
  • Changes in Forearm, femur and spine bone mineral density, T score and Z score
    • Time Frame: over 24 months
    • Bone mineral density related parameters

Participating in This Clinical Trial

Inclusion Criteria

  • ESRD patients receiving long-term peritoneal dialysis treatment with hyperphosphatemia currently receiving aluminum-based phosphorus binders or whose phosphorus control remains suboptimal with calcium-based binders only – Patients who cannot afford to self-pay sevelamer hydrochloride. – Patients who provided informed consent for the study Exclusion Criteria:

  • Patients with underlying active malignancy – Patients with cyanotic congenital heart disease – Patients with poor general condition – Patients with plan for living related kidney transplant within coming 1 year – Female patients with pregnancy

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Hong Kong
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Angela Yee-Moon Wang, Dr. – The University of Hong Kong
  • Overall Official(s)
    • Angela YM Wang, MD, PhD, Principal Investigator, Queen Mary Hospital, University of Hong Kong

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