Sevelamer Hydrochloride in Peritoneal Dialysis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Sevelamer Hydrochloride to Control Hyperphosphatemia and Reduce Calcification Burden in the Poor Peritoneal Dialysis Patients

Conditions
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Endstage Renal Disease

Intervention / Treatment
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* Drug: sevelamer hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: higher dose sevelamer<br>first-line higher dose sevelamer hydrochloride | Drug: sevelamer hydrochloride<br>* 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)<br>* Other names: Renagel;|
| Active Comparator: low dose sevelamer<br>second-line fixed low-dose sevelamer hydrochloride added to calcium carbonate | Drug: sevelamer hydrochloride<br>* 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)<br>* Other names: Renagel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in coronary artery, aortic valve, mitral annulus calcium scores | Vascular and valvular calcium scores | over 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular,, valvular calcification,, phosphate binder,, sevelamer,, endstage renal disease, peritoneal dialysis