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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN012606000380594 |
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Approximately 45 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 20 sites within Europe and 5-10 in Australia. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 14 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sevelamer Carbonate Tablets Dosed Three Times A Day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevelamer carbonate (Renvela®) | Drug | Sevelamer Carbonate Tablets Dosed Three Times A Day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels | Up to day 70 | |
| Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals. | Up to day 70 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum calcium-phosphorus product | Up to day 70 | |
| Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol] | Up to day 70 | |
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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 |
|---|---|---|---|---|---|---|
| Nephrology Department, Princess Alexandra Hospital | Wooloongabba | Queensland | 4102 | Australia | ||
| Renal Unit, The Queen Elizabeth Hospital |
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| Percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.87 and 1.49 mmol/L) inclusive] at Day 56/ET |
| Up to day 70 |
| Woodville |
| South Australia |
| 5011 |
| Australia |
| Renal Research Unit, Launceston General Hospital | Launceston | Tasmania | 7250 | Australia |
| The Royal Melbourne Hospital, Department of Nephrology | Parkville | Victoria | 3050 | Australia |
| Melbourne Renal Research Group, Epworth Medical Centre | Richmond | Victoria | 3121 | Australia |
| Nyremedicinsk Afdeling, Medicinerhuset | Aalborg | DK-9100 | Denmark |
| Medicinsk Afdeling | Copenhagen | DK-2100 | Denmark |
| Nefrologisk Afdeling, Hilleroed Sygehus | Hilleroed | DK 3400 | Denmark |
| Medicinsk Afdeling, nefrologisk, Roskilde Sygehus | Roskilde | DK-4000 | Denmark |
| George Pompidou, European Hospital | Paris | 75908 | France |
| Universitätsklinikum Aachen, Medizinsche Klinik II | Aachen | D-52074 | Germany |
| Universitätsklinikum Hamburg Eppendorf | Hamburg | D-20246 | Germany |
| Heimdialysezentrum | Heidelberg | D-69115 | Germany |
| KfH Nierenzentrum | Nuremberg | D-90431 | Germany |
| Stadt Klinken Solingen, Klinik für Nephrologie und Allgemeine Innere Medizin | Solingen | D 42653 | Germany |
| Nephrologisches Zentrum | Villingen-Schwenningen | D 78054 | Germany |
| Birmingham Hospital, Queen Elizabeth Medical Centre | Birmingham | England | B15 2PR | United Kingdom |
| Southmead Hospital | Bristol | England | BS10 5NB | United Kingdom |
| Addenbrooke's Dialysis Centre | Cambridge | England | CB2 2QQ | United Kingdom |
| Leicester General Hospital | Leicester | England | LE5 4PW | United Kingdom |
| Renal Department, The Royal London Hospital | London | England | E1 1BB | United Kingdom |
| Renal & Urology SDU Offices | London | England | SE1 9RT | United Kingdom |
| Renal Dialysis Unit, Manchester Royal Infirmary | Manchester | England | M13 9WL | United Kingdom |
| Department of Renal Medicine, Hope Hospital | Manchester | England | M6 8HD | United Kingdom |
| Renal Unit, Queen Alexandra Hospital | Portsmouth | England | PO6 3RY | United Kingdom |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D054559 | Hyperphosphatemia |
| 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 |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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