Sevelamer Hydrochloride in Peritoneal Dialysis Patients

The University of Hong Kong60 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endstage Renal Disease

Interventions

sevelamer hydrochlorideDRUG

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)

Eligibility

Sex: ALLMin age: 25 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Queen Mary Hospital, Tung Wah Hospital

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Changes in coronary artery, aortic valve, mitral annulus calcium scores

Vascular and valvular calcium scores

Time frame: over 24 months

Secondary Outcomes

Changes in aortic pulse wave velocity

arterial stiffness parameter

Time frame: over 24 months

annualized percentage change in Coronary artery calcium score

annualized percentage change in calcium score

Time frame: over 12 months

Changess in serum T50

serum calcification propensity measure

Time frame: over 24 months

Changes in serum calcium, phosphate

biochemical parameters

Time frame: over 24 months

Changes in alkaline phosphatase

biochemical parameters

Time frame: over 24 months

Changes in intact parathyroid hormone

biochemical parameters

Time frame: over 24 months

Changes in low density lipoprotein-cholesterol

biochemical parameters

Time frame: over 24 months

Changes in C-reactive protein

biochemical parameters

Time frame: over 24 months

Data from ClinicalTrials.gov

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