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The study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients on dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevelamer carbonate | Experimental | Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site. |
|
| Placebo | Placebo Comparator | Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous. | 8 weeks | |
| Frequency of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, and changes in vital signs. | 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol). | 8 weeks |
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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 |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | China | ||||
| Peking University First Hospital |
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| Sevelamer carbonate | Drug |
|
|
|
| Beijing |
| China |
| Sichuan Provincial People's Hospital | Chengdu | China |
| West China Hospital | Chengdu | China |
| Southwest Hospital | Chongqing | China |
| Guangzhou First Municipal People's Hospital | Guangzhou | China |
| Nanfang Hospital | Guangzhou | China |
| Sun Yat-Sen University School of Medicine 1st Affiliated Hospital | Guangzhou | China |
| Zhejiang University School of Medicine 1st Affiliated Hospital | Hangzhou | China |
| Jiangsu Province Hospital | Nanjing | China |
| Zhongda Hospital of Southeast University | Nanjing | China |
| Qingdao Municipal Hospital | Qingdao | China |
| Changzheng Hospital | Shanghai | China |
| Renji Hospital | Shanghai | China |
| Shanghai Ruijin Hospital | Shanghai | China |
| Xinhua Hospital | Shanghai | China |
| Zhongshan Hospital | Shanghai | China |
| Wenzhou College of Medicine 1st Affiliated Hospital | Wenzhou | China |
| 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 |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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