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The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevelamer Hydrochloride (Renagel®) | Experimental |
| |
| Calcium acetate (PhosLo® ) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevelamer Hydrochloride (Renagel®) | Drug | Sevelamer hydrochloride three times per day with each meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum calcium- phosphorus (CaxPO4) product | 12 weeks | |
| Serum lipids - total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides | 12 weeks | |
| Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gasthuisberg | Leuven | B-3000 | Belgium | |||
| Aarhus University Hospital |
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| Calcium acetate (PhosLo® ) | Drug | Calcium acetate three times per day with each meal |
|
| 12 weeks |
| Århus N |
| DN-8200 |
| Denmark |
| Fredericia Sygehus | Fredericia | DN-7000 | Denmark |
| Copenhagen University Hospital | Herlev | DN-2730 | Denmark |
| CHRU Clémenceau | Caen | FR-14033 | France |
| Ospedale civico e benfratelli | Palermo | IT-90127 | Italy |
| Ospedale San Bortolo | Vicenza | IT-36100 | Italy |
| AMC | Amsterdam | NL-1105 AZ | Netherlands |
| Fundacion Jimenez Diaz | Madrid | ES-28040 | Spain |
| Hospital Universitario La Paz | Madrid | ES-28046 | Spain |
| University Hospital ,Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| High Wycombe Hospital | Buckinghamshire | HP11 2TT | United Kingdom |
| University of Wales College of Medicine | Cardiff | CF 14 4XN | United Kingdom |
| Glasgow Western Infirmary | Glasgow | G11 6NT | United Kingdom |
| Royal Hospital The Royal London | London | E1 1BB | United Kingdom |
| Milton Keynes General Hospital | Milton Keynes | MK6 5LD | United Kingdom |
| The Churchill Hospital, Oxford Radcliffe Hospitals NHS Trust | Oxford | OX3 7LJ | United Kingdom |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| C120662 | calcium acetate |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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