| Primary | Change in Endotoxin | Change in LPS from baseline to week 8, where baseline value is the average of pre-entry and entry values. | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in primary analysis. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Sign test | | 0.87 | not adjusted for multiple comparisons | | | | | | | | | | | | | Superiority or Other | | |
|
| Primary | Change in Soluble CD14 (sCD14) | Change in soluble CD14 (sCD14) from baseline to week 8, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in primary analysis. | Posted | | Median | Inter-Quartile Range | ug/mL | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Endotoxin | Change in endotoxin from baseline to week 4, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Endotoxin | Change in endotoxin from week 8 to week 16 | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid endpoint at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | pg/mL | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in sCD14 | Change in sCD14 from baseline to week 4, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects have valid data at baseline and week 4 and were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | ug/mL | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in sCD14 | Change in sCD14 from week 8 to week 16 | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects had valid data at both week 8 and week 16 and were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | ug/mL | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in CD4+ T-cell Activation | Change from baseline to week 8 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | percentage | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in CD4+ T-cell Activation | Change from baseline to week 4 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at baseline and week 4 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | percentage | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in CD4+ T-cell Activation | Change from week 8 to week 16 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+ | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 30 subjects with valid data at week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | percentage | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in CD8+ T-cell Activation | Change from baseline to week 4 in CD8+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at baseline and week 4 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | percentage | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in CD8+ T-cell Activation | Change in CD8+ T-cell activation defined as the %CD38+/HLA-DR+ from baseline to week 8, where baseline is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | percentage | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in CD8+ T-cell Activation | Change in CD8+ T-cell activation defined as the %CD38+/HLA-DR+ from week 8 to week 16 | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 30 subjects with valid data at week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | percentage | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Proportion of Cycling CD8+ | Change from baseline to week 4 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects have valid data at baseline and week 4 and were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | percentage | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Proportion of Cycling CD8+ | Change from baseline to week 8 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | percentage | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Proportion of Cycling CD8+ | Change from week 8 to week 16 in cycling CD8+ , defined as the %Ki67+ | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 29 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | percentage | | from week 8 to week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Proportion of Cycling CD4+ | Change from baseline to week 4 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | percentage | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Proportion of Cycling CD4+ | Change from baseline to week 8 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at both baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | percentage | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Proportion of Cycling CD4+ | Change from week 8 to week 16 in cycling CD4+ , defined as the %Ki67+ | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 29 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | percentage | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Blood Phosphate Levels | Change in blood phosphate levels from baseline to week 4, where baseline value is the average of pre-entry and entry | Among 40 subjects enrolled in A5296, 39 subjects with valid data at both baseline and week 4 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | from baseline to week 4 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Blood Phosphate Levels | Change in blood phosphate levels from baseline to week 8 | Among 40 subjects enrolled in A5296, 37 subjects with valid data at both baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| | |
| Secondary | Change in Blood Phosphate Levels | Change in blood phosphate levels from week 8 to week 16 | Among 40 subjects enrolled in A5296, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | from week 8 to week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| | |
| Secondary | Change in log10 HIV RNA Levels | Change in log10 HIV RNA levels from baseline to week 4, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | log10(copies/mL) | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in log10 HIV RNA Levels | Change in log10 HIV RNA levels from baseline to week 8, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | log10(copies/mL) | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in log10 HIV RNA Levels | Change in log10 HIV RNA levels from week 8 to week 16 | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | log10(copies/mL) | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in CD4+ T-cell Counts | Change in CD4+ T-cell counts from baseline to week 4, where baseline is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 4 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | cells/mm^3 | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in CD4+ T-cell Counts | Change in CD4+ T-cell counts from baseline to week 8, where baseline is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | cells/mm^3 | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in CD4+ T-cell Counts | Change in CD4+ T-cell counts from week 8 to week 16 | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | cells/mm^3 | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in IL-6 | Changes in levels of systemic inflammation marker IL-6 from baseline to week 4, where baseline is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All subjects had valid data at both baseline and week 4 and were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in IL-6 | Changes in levels of systemic inflammation marker IL-6 from baseline to week 8, where baseline is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in IL-6 | Changes in levels of systemic inflammation marker IL-6 from week 8 to week 16 | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | pg/mL | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in C-reactive Protein (CRP) | Changes in levels of systemic inflammation marker CRP from baseline to week 4, where baseline is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | ng/mL | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in CRP | Changes in levels of systemic inflammation marker CRP from baseline to week 8, where baseline is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | ng/mL | | Baseline and Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in CRP | Changes in levels of systemic inflammation marker CRP from week 8 to week 16, where baseline is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | ng/mL | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in D-dimer | Change in levels of coagulation biomarker d-dimer from baseline to week 4, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | ng/mL | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in D-dimer | Change in levels of coagulation biomarker d-dimer from baseline to week 8, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | ng/mL | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in D-dimer | Change in levels of coagulation biomarker d-dimer from week 8 to week 16 | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | ng/mL | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Tissue Factor | Change in levels of coagulation biomarker tissue factor from baseline to week 4, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Tissue Factor | Change in levels of coagulation biomarker tissue factor from baseline to week 8, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | pg/mL | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Tissue Factor | Change in levels of coagulation biomarker tissue factor from week 8 to week 16 | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | pg/mL | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Total Cholesterol | Change in total cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Total Cholesterol | Change in total cholesterol from week 8 to week 16 | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in LDL Cholesterol | Change in fasting LDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in LDL Cholesterol | Change in fasting LDL cholesterol from week 8 to week 16 | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in HDL Cholesterol | Change in fasting HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in HDL Cholesterol | Change in fasting HDL cholesterol from week 8 to week 16 | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | from week 8 to week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Non-HDL Cholesterol | Change in non-HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Non-HDL Cholesterol | Change in non-HDL cholesterol from week 8 to week 16 | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Fasting Glucose | Change in fasting glucose from baseline to week 8, where baseline value is the average of pre-entry and entry | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Change in Fasting Glucose | Change in fasting glucose from week 8 to week 16 | This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis. | Posted | | Median | Inter-Quartile Range | mg/dL | | week 8 and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| |
| Secondary | Primary Adverse Events | Number of subjects experiencing primary adverse events, defined as all reported Grade ≥ 2 signs and symptoms, Grade ≥ 2 laboratory abnormalities and other serious adverse events (SAEs) | All 40 subjects enrolled in A5296 were included in this analysis. | Posted | | Number | | participants | | baseline and week 16 | | | | ID | Title | Description |
|---|
| OG000 | Sevelamer Carbonate | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
| | |