Endstage Renal Disease
Conditions
Keywords
vascular,, valvular calcification,, phosphate binder,, sevelamer,, endstage renal disease, peritoneal dialysis
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.
Interventions
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)
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in coronary artery, aortic valve, mitral annulus calcium scores | over 24 months | Vascular and valvular calcium scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in aortic pulse wave velocity | over 24 months | arterial stiffness parameter |
| Changes in Forearm, femur and spine bone mineral density, T score and Z score | over 24 months | Bone mineral density related parameters |
| 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 diastolic blood pressure | over 24 months | blood pressure |
| 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 alkaline phosphatase | over 24 months | biochemical parameters |
Countries
Hong Kong
Outcome results
None listed