Trial Outcomes & Findings for Sevelamer for Reducing Endotoxemia and Immune Activation (NCT NCT01543958)
NCT ID: NCT01543958
Last Updated: 2018-10-11
Results Overview
Change in LPS from baseline to week 8, where baseline value is the average of pre-entry and entry values.
COMPLETED
PHASE2
40 participants
baseline and Week 8
2018-10-11
Participant Flow
A5296 accrual opened under protocol version 1.0 on 11/21/11, and the first subject was enrolled on 12/29/11. Accrual to the study closed on 8/1/12, with a total of 40 subjects enrolled from 15 sites within the US.
Participant milestones
| Measure |
Sevelamer Carbonate
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Sevelamer Carbonate
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Overall Study
Loss to follow-up
|
3
|
|
Overall Study
ART initiation
|
1
|
Baseline Characteristics
Sevelamer for Reducing Endotoxemia and Immune Activation
Baseline characteristics by cohort
| Measure |
Sevelamer Carbonate
n=40 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
44 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
10 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
24 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic (regardless of Race)
|
6 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
|
Log10 HIV-1 RNA
|
3.58 copies/mL
n=99 Participants
|
|
CD4 count
|
580 cells/mm^3
n=99 Participants
|
PRIMARY outcome
Timeframe: baseline and Week 8Population: 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.
Change in LPS from baseline to week 8, where baseline value is the average of pre-entry and entry values.
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Endotoxin
|
0.20 pg/mL
Interval -4.06 to 5.81
|
PRIMARY outcome
Timeframe: baseline and week 8Population: 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.
Change in soluble CD14 (sCD14) from baseline to week 8, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Soluble CD14 (sCD14)
|
-0.02 ug/mL
Interval -0.18 to 0.06
|
SECONDARY outcome
Timeframe: baseline and week 4Population: 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.
Change in endotoxin from baseline to week 4, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Endotoxin
|
1.08 pg/mL
Interval -2.51 to 7.71
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Change in endotoxin from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=33 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Endotoxin
|
-2.39 pg/mL
Interval -8.04 to 2.65
|
SECONDARY outcome
Timeframe: baseline and week 4Population: 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.
Change in sCD14 from baseline to week 4, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in sCD14
|
-0.09 ug/mL
Interval -0.23 to 0.11
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Change in sCD14 from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=34 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in sCD14
|
0.06 ug/mL
Interval -0.03 to 0.24
|
SECONDARY outcome
Timeframe: baseline and week 8Population: 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.
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
Outcome measures
| Measure |
Sevelamer Carbonate
n=33 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in CD4+ T-cell Activation
|
0.050 percentage
Interval -0.65 to 2.6
|
SECONDARY outcome
Timeframe: baseline and week 4Population: 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.
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
Outcome measures
| Measure |
Sevelamer Carbonate
n=35 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in CD4+ T-cell Activation
|
0.4 percentage
Interval -0.95 to 1.2
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Change from week 8 to week 16 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+
Outcome measures
| Measure |
Sevelamer Carbonate
n=30 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in CD4+ T-cell Activation
|
0.45 percentage
Interval -0.8 to 1.6
|
SECONDARY outcome
Timeframe: baseline and week 4Population: 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.
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
Outcome measures
| Measure |
Sevelamer Carbonate
n=35 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in CD8+ T-cell Activation
|
-0.05 percentage
Interval -4.35 to 3.15
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
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
Outcome measures
| Measure |
Sevelamer Carbonate
n=33 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in CD8+ T-cell Activation
|
-0.450 percentage
Interval -1.75 to 1.95
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Change in CD8+ T-cell activation defined as the %CD38+/HLA-DR+ from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=30 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in CD8+ T-cell Activation
|
-0.15 percentage
Interval -1.9 to 6.0
|
SECONDARY outcome
Timeframe: baseline and week 4Population: 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.
Change from baseline to week 4 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Proportion of Cycling CD8+
|
-0.125 percentage
Interval -0.55 to 0.275
|
SECONDARY outcome
Timeframe: baseline and week 8Population: 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.
Change from baseline to week 8 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=32 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Proportion of Cycling CD8+
|
0.1 percentage
Interval -0.425 to 0.775
|
SECONDARY outcome
Timeframe: from week 8 to week 16Population: 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.
Change from week 8 to week 16 in cycling CD8+ , defined as the %Ki67+
Outcome measures
| Measure |
Sevelamer Carbonate
n=29 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Proportion of Cycling CD8+
|
0.300 percentage
Interval -0.5 to 0.9
|
SECONDARY outcome
Timeframe: baseline and week 4Population: 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.
Change from baseline to week 4 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Proportion of Cycling CD4+
|
0.125 percentage
Interval -0.375 to 0.575
|
SECONDARY outcome
Timeframe: baseline and week 8Population: 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.
Change from baseline to week 8 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=32 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Proportion of Cycling CD4+
|
0.025 percentage
Interval -0.575 to 0.4
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Change from week 8 to week 16 in cycling CD4+ , defined as the %Ki67+
Outcome measures
| Measure |
Sevelamer Carbonate
n=29 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Proportion of Cycling CD4+
|
0.2 percentage
Interval -0.3 to 0.8
|
SECONDARY outcome
Timeframe: from baseline to week 4Population: Among 40 subjects enrolled in A5296, 39 subjects with valid data at both baseline and week 4 were included in this secondary analysis.
Change in blood phosphate levels from baseline to week 4, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=39 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Blood Phosphate Levels
|
0 mg/dL
Interval -0.2 to 0.6
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Among 40 subjects enrolled in A5296, 37 subjects with valid data at both baseline and week 8 were included in this secondary analysis.
Change in blood phosphate levels from baseline to week 8
Outcome measures
| Measure |
Sevelamer Carbonate
n=37 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Blood Phosphate Levels
|
-0.1 mg/dL
Interval -0.3 to 0.2
|
SECONDARY outcome
Timeframe: from week 8 to week 16Population: Among 40 subjects enrolled in A5296, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.
Change in blood phosphate levels from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=34 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Blood Phosphate Levels
|
0.10 mg/dL
Interval -0.3 to 0.4
|
SECONDARY outcome
Timeframe: baseline and week 4Population: 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.
Change in log10 HIV RNA levels from baseline to week 4, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in log10 HIV RNA Levels
|
0.02 log10(copies/mL)
Interval -0.09 to 0.14
|
SECONDARY outcome
Timeframe: baseline and week 8Population: 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.
Change in log10 HIV RNA levels from baseline to week 8, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in log10 HIV RNA Levels
|
-0.02 log10(copies/mL)
Interval -0.12 to 0.1
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Change in log10 HIV RNA levels from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=34 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in log10 HIV RNA Levels
|
0.16 log10(copies/mL)
Interval -0.11 to 0.31
|
SECONDARY outcome
Timeframe: baseline and week 4Population: 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.
Change in CD4+ T-cell counts from baseline to week 4, where baseline is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=35 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in CD4+ T-cell Counts
|
-25 cells/mm^3
Interval -86.0 to 40.0
|
SECONDARY outcome
Timeframe: baseline and week 8Population: 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.
Change in CD4+ T-cell counts from baseline to week 8, where baseline is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in CD4+ T-cell Counts
|
-14 cells/mm^3
Interval -70.0 to 45.0
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Change in CD4+ T-cell counts from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=34 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in CD4+ T-cell Counts
|
-1 cells/mm^3
Interval -93.0 to 69.0
|
SECONDARY outcome
Timeframe: baseline and week 4Population: 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.
Changes in levels of systemic inflammation marker IL-6 from baseline to week 4, where baseline is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in IL-6
|
0.28 pg/mL
Interval -0.13 to 0.72
|
SECONDARY outcome
Timeframe: baseline and week 8Population: 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.
Changes in levels of systemic inflammation marker IL-6 from baseline to week 8, where baseline is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in IL-6
|
-0.02 pg/mL
Interval -0.58 to 0.63
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Changes in levels of systemic inflammation marker IL-6 from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=34 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in IL-6
|
0.19 pg/mL
Interval -0.43 to 1.07
|
SECONDARY outcome
Timeframe: baseline and week 4Population: 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.
Changes in levels of systemic inflammation marker CRP from baseline to week 4, where baseline is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in C-reactive Protein (CRP)
|
-141 ng/mL
Interval -1283.5 to 845.0
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: 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.
Changes in levels of systemic inflammation marker CRP from baseline to week 8, where baseline is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in CRP
|
45.5 ng/mL
Interval -652.5 to 1539.5
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Changes in levels of systemic inflammation marker CRP from week 8 to week 16, where baseline is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=34 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in CRP
|
-34 ng/mL
Interval -493.0 to 527.0
|
SECONDARY outcome
Timeframe: baseline and week 4Population: 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.
Change in levels of coagulation biomarker d-dimer from baseline to week 4, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in D-dimer
|
5.95 ng/mL
Interval -28.87 to 55.02
|
SECONDARY outcome
Timeframe: baseline and week 8Population: 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.
Change in levels of coagulation biomarker d-dimer from baseline to week 8, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in D-dimer
|
20.30 ng/mL
Interval -16.08 to 74.9
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Change in levels of coagulation biomarker d-dimer from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=34 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in D-dimer
|
-17.15 ng/mL
Interval -66.0 to 25.8
|
SECONDARY outcome
Timeframe: baseline and week 4Population: 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.
Change in levels of coagulation biomarker tissue factor from baseline to week 4, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Tissue Factor
|
-2.47 pg/mL
Interval -6.03 to 0.15
|
SECONDARY outcome
Timeframe: baseline and week 8Population: 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.
Change in levels of coagulation biomarker tissue factor from baseline to week 8, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Tissue Factor
|
-2 pg/mL
Interval -6.7 to -0.1
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Change in levels of coagulation biomarker tissue factor from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=34 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Tissue Factor
|
3.8 pg/mL
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: baseline and week 8Population: 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.
Change in total cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=35 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Total Cholesterol
|
-12.5 mg/dL
Interval -28.5 to 5.5
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Change in total cholesterol from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=33 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Total Cholesterol
|
9 mg/dL
Interval -4.0 to 25.0
|
SECONDARY outcome
Timeframe: baseline and week 8Population: 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.
Change in fasting LDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=34 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in LDL Cholesterol
|
-18.25 mg/dL
Interval -32.2 to 1.5
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Change in fasting LDL cholesterol from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=32 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in LDL Cholesterol
|
14.20 mg/dL
Interval -0.5 to 32.5
|
SECONDARY outcome
Timeframe: baseline and week 8Population: 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.
Change in fasting HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=35 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in HDL Cholesterol
|
0.50 mg/dL
Interval -5.0 to 4.0
|
SECONDARY outcome
Timeframe: from week 8 to week 16Population: 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.
Change in fasting HDL cholesterol from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=33 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in HDL Cholesterol
|
1 mg/dL
Interval -3.0 to 5.0
|
SECONDARY outcome
Timeframe: baseline and week 8Population: 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.
Change in non-HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=35 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Non-HDL Cholesterol
|
-12 mg/dL
Interval -25.0 to 2.0
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Change in non-HDL cholesterol from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=33 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Non-HDL Cholesterol
|
4 mg/dL
Interval -2.0 to 24.0
|
SECONDARY outcome
Timeframe: baseline and week 8Population: 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.
Change in fasting glucose from baseline to week 8, where baseline value is the average of pre-entry and entry
Outcome measures
| Measure |
Sevelamer Carbonate
n=36 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Fasting Glucose
|
-2 mg/dL
Interval -12.75 to 2.92
|
SECONDARY outcome
Timeframe: week 8 and week 16Population: 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.
Change in fasting glucose from week 8 to week 16
Outcome measures
| Measure |
Sevelamer Carbonate
n=34 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Change in Fasting Glucose
|
3.5 mg/dL
Interval -3.0 to 15.0
|
SECONDARY outcome
Timeframe: baseline and week 16Population: All 40 subjects enrolled in A5296 were included in this analysis.
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)
Outcome measures
| Measure |
Sevelamer Carbonate
n=40 Participants
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Primary Adverse Events
|
28 participants
|
Adverse Events
Sevelamer Carbonate
Serious adverse events
| Measure |
Sevelamer Carbonate
n=40 participants at risk
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.5%
1/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
Other adverse events
| Measure |
Sevelamer Carbonate
n=40 participants at risk
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
|
|---|---|
|
Eye disorders
Conjunctivitis
|
5.0%
2/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
2/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Gastrointestinal disorders
Constipation
|
5.0%
2/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
2/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
2/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Investigations
Blood bicarbonate decreased
|
22.5%
9/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Investigations
Blood calcium decreased
|
20.0%
8/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Investigations
Blood cholesterol increased
|
27.5%
11/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Investigations
Blood glucose decreased
|
12.5%
5/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Investigations
Blood glucose increased
|
22.5%
9/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Investigations
Blood phosphorus decreased
|
25.0%
10/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Investigations
Blood sodium decreased
|
7.5%
3/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Investigations
Haemoglobin decreased
|
5.0%
2/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Investigations
Low density lipoprotein increased
|
15.0%
6/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
|
Investigations
Neutrophil count decreased
|
5.0%
2/40 • AEs reported from study enrollment until study completion at week 16
AE reporting followed DAIDS reporting level
|
Additional Information
ACTG ClinicalTrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place