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| ID | Type | Description | Link |
|---|---|---|---|
| SVCARB01508IST | |||
| 2008-003727-23 |
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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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The purpose of this study is to determine whether lowering phosphate in patients with early chronic kidney disease with the phosphate binder sevelamer has beneficial effects on cardiovascular structure and function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks |
|
| 2 | Placebo Comparator | Treatment group: treatment with tablets of placebo three times daily for 36 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevelamer carbonate | Drug | Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular mass | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic compliance as measured by cardiac magnetic resonance imaging | 36 weeks | |
| Arterial stiffness as measured by pulse wave velocity and pulse wave analysis | 36 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles J Ferro, BSc (Hons), MBChB, FRCP, MD | University Hospital Birmingham NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Birmingham NHS Foundation Trust | Birmingham | West Midlands | B15 2TH | United Kingdom |
| 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. | |
| 21288351 | Derived | Chue CD, Townend JN, Steeds RP, Ferro CJ. Evaluating the effects of sevelamer carbonate on cardiovascular structure and function in chronic renal impairment in Birmingham: the CRIB-PHOS randomised controlled trial. Trials. 2011 Feb 2;12:30. doi: 10.1186/1745-6215-12-30. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Treatment group: treatment with tablets of placebo three times daily for 36 weeks |
|
| Arterial elastance as measured by echocardiography |
| 36 weeks |
| Left ventricular systolic and diastolic elastance measured by echocardiography | 36 weeks |
| Bone density on dual-energy x-ray absorptiometry scanning | 36 weeks |
| 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 |