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The primary objective of this study is to assess in a post-approval clinical setting the safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of Product Characteristics (SmPC) and followed according to the investigator's standard clinical practice management. Each patient will be followed up for 12 months or up to the time they start dialysis, whichever occurs first.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sevelamer carbonate (Renvela®) | Drug | 800 mg tablets or 2.4 g powder for oral suspension should be administered as instructed in the Renvela® SmPC. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of non-serious and Serious Adverse Drug Reaction (ADRs) | Assess safety profile of Renvela tablets and powder | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult Chronic Kidney Disease (CKD) patients not on dialysis with serum phosphorus ≥ 1.78 mmol/L.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graz | Austria | |||||
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| Linz |
| Austria |
| Aalborg | Denmark |
| Cabestany | France |
| Dijon | France |
| Lille | France |
| Saint-Laurent-du-Var | France |
| Toulouse | France |
| Berlin | Germany |
| Dortmund | Germany |
| Hanover | Germany |
| Mettmann | Germany |
| Wiesbaden | Germany |
| Acireale | Italy |
| Milan | Italy |
| Naples | Italy |
| Palermo | Italy |
| Pavia | Italy |
| Pesaro | Italy |
| Rome | Italy |
| Amsterdam | Netherlands |
| Breda | Netherlands |
| Dordrecht | Netherlands |
| Leiden | Netherlands |
| Madrid | Spain |
| Valencia | Spain |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| 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 |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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