Sevelamer Hydrochloride in Peritoneal Dialysis Patients

Not Applicable

Completed

• Conditions: Endstage Renal Disease
• Interventions: Drug: sevelamer hydrochloride

• Registration Number: NCT00745589
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-01
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Primary Completion: 2014-10
• Study Completion: 2015-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-17
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
higher dose sevelamer	sevelamer hydrochloride	first-line higher dose sevelamer hydrochloride
low dose sevelamer	sevelamer hydrochloride	second-line fixed low-dose sevelamer hydrochloride added to calcium carbonate

Primary Outcome Measures

Name	Time	Method
Changes in coronary artery, aortic valve, mitral annulus calcium scores	over 24 months	Vascular and valvular calcium scores

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Queen Mary Hospital, Tung Wah Hospital; 🇭🇰 Hong Kong, Hong Kong