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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| higher dose sevelamer | Active Comparator | first-line higher dose sevelamer hydrochloride |
|
| low dose sevelamer | Active Comparator | second-line fixed low-dose sevelamer hydrochloride added to calcium carbonate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sevelamer hydrochloride | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in coronary artery, aortic valve, mitral annulus calcium scores | Vascular and valvular calcium scores | over 24 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela YM Wang, MD, PhD | Queen Mary Hospital, University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital, Tung Wah Hospital | Hong Kong | 0000 | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. | |
| 35243302 | Derived | Wang AY, Pasch A, Wong CK, Chu IM, Tang TK, Chu J, Cheuk-Ying Fong C, Yau YY, Lo WK. Long-Term Effects of Sevelamer on Vascular Calcification, Arterial Stiffness, and Calcification Propensity in Patients Receiving Peritoneal Dialysis: The Randomized Pilot SERENE (Sevelamer on Vascular Calcification, Arterial Stiffness) Trial. Kidney Med. 2021 Nov 2;4(2):100384. doi: 10.1016/j.xkme.2021.10.002. eCollection 2022 Feb. |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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|
| 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 |