FindTrial
Sign In

A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease Including Assessment of Quality of Life (EPPIC-2)

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease Including Assessment of Quality of Life

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00501046
Enrollment
1015
Registered
2007-07-13
Start date
2007-07-31
Completion date
2011-10-31
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Kidney Diseases

Brief summary

1\) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate the effects of AST-120 versus placebo, on other measures of renal function and quality of life.

Interventions

DRUGPlacebo

9g /day (3 times a day)

DRUGAST-120

9g /day (3 times a day)

Sponsors

Kureha Corporation
CollaboratorINDUSTRY
Tanabe Pharma Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years or older * Moderate to severe CKD, not anticipated to require dialysis or renal transplant within the next 6 months * Patient survival expected to be no less than one year * Serum creatinine in men \>= 2.0 mg/dL (\>= 177 µmol/L) and \<= 5.0 mg/dL (\<= 442 µmol/L), and in women \>= 1.5 mg/dL (\>= 133 µmol/L) and \<= 5.0 mg/dL (\<= 442 µmol/L) at Screening * Urinary total protein to urinary total creatinine ratio must be \>= 0.5 on a spot void obtained at Screening * Blood pressure \<= 160/90 mmHg at both Screening and Baseline visits. In addition, blood pressure, if measured, must have been stable in hypertensive patients over the 3 months prior to Screening, with no more than 1 blood pressure reading \> 160/90 mmHg * In patients being treated for hypertension, they should be on a stable anti-hypertensive regimen

Exclusion criteria

* Obstructive or reversible cause of kidney disease * Nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine of \> 6.0 as measured on a spot void * Adult polycystic kidney disease * History of previous kidney transplant * History of recent (within the past 6 months) accelerated or malignant hypertension * Uncontrolled arrhythmia or severe cardiac disease within the past 6 months * History of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, or severe GI dysmotility, not attributable to the use of a phosphate binder * Received any investigational agent or participated in a clinical study within the previous 3 months * Presence of any significant medical condition that might create an undue risk with study participation, or significantly confound the collection of safety and efficacy data in this study

Design outcomes

Primary

MeasureTime frame
Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint
Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse EventsApproximately 42 months

Secondary

MeasureTime frame
Number of Participants Who Developed a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death)approximately 42 months
Vitamin A LevelsBaseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 430.293 Days), Final Visit (Mean: 908.486 Days)
Vitamin B12 LevelsBaseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 425.112 Days), Final Visit (Mean: 910.988 Days)
25-Hydroxyvitamin D LevelsBaseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 429.695 Days), Final Visit (Mean: 908.601 Days)
Vitamin E LevelsBaseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 427.067 Days), Final Visit (Mean: 908.715 Days)
Vitamin K LevelsBaseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 432.942 Days), Final Visit (Mean: 910.448 Days)
Serum Folate LevelsBaseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 420.569 Days), Final Visit (Mean: 909.848 Days)

Countries

Argentina, Brazil, Canada, Czechia, Germany, Mexico, Poland, Puerto Rico, Russia, Spain, Ukraine, United States

Participant flow

Participants by arm

ArmCount
AST-120
AST-120: 9g /day (3 times a day)
508
Placebo
Placebo: 9g /day (3 times a day)
507
Total1,015

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event2125
Overall StudyDeath2330
Overall StudyLost to Follow-up1413
Overall StudyPhysician Decision72
Overall StudyPregnancy03
Overall StudyProtocol Violation21
Overall StudyReaching endpoints,Noncompliance,etc119137
Overall StudyWithdrawal by Subject8483

Baseline characteristics

CharacteristicAST-120PlaceboTotal
Age, Continuous54.4 years
STANDARD_DEVIATION 15.52
55.7 years
STANDARD_DEVIATION 14.66
55.1 years
STANDARD_DEVIATION 15.11
Sex: Female, Male
Female
229 Participants226 Participants455 Participants
Sex: Female, Male
Male
279 Participants281 Participants560 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
393 / 507377 / 505
serious
Total, serious adverse events
156 / 507178 / 505

Outcome results

Primary

Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.

Time frame: Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint

Population: ITT (censored at last contact)

ArmMeasureValue (NUMBER)
AST-120Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.172 participants
PlaceboComposite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.183 participants
Primary

Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events

Time frame: Approximately 42 months

Population: Safety population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
AST-120Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse EventsTreatment-emergent AE438 Participants
AST-120Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse EventsTreatment-emergent SAE156 Participants
PlaceboNumber of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse EventsTreatment-emergent AE425 Participants
PlaceboNumber of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse EventsTreatment-emergent SAE178 Participants
Secondary

25-Hydroxyvitamin D Levels

Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 429.695 Days), Final Visit (Mean: 908.601 Days)

Population: Safety population. This analysis was performed using the data only from patients who had the data at each visit.

ArmMeasureGroupValue (MEAN)Dispersion
AST-12025-Hydroxyvitamin D LevelsWeek 7222.56 ng/mLStandard Deviation 11.326
AST-12025-Hydroxyvitamin D LevelsWeek 4821.10 ng/mLStandard Deviation 10.195
AST-12025-Hydroxyvitamin D LevelsWeek 18033.63 ng/mLStandard Deviation 15.515
AST-12025-Hydroxyvitamin D LevelsWeek 6021.39 ng/mLStandard Deviation 10.139
AST-12025-Hydroxyvitamin D LevelsBaseline21.09 ng/mLStandard Deviation 10.391
AST-12025-Hydroxyvitamin D LevelsWeek 8422.29 ng/mLStandard Deviation 9.967
AST-12025-Hydroxyvitamin D LevelsWeek 15627.30 ng/mLStandard Deviation 14.396
AST-12025-Hydroxyvitamin D LevelsWeek 9622.63 ng/mLStandard Deviation 10.563
AST-12025-Hydroxyvitamin D LevelsWeek 1221.64 ng/mLStandard Deviation 9.981
AST-12025-Hydroxyvitamin D LevelsWeek 10822.97 ng/mLStandard Deviation 10.305
AST-12025-Hydroxyvitamin D LevelsWeek 14425.02 ng/mLStandard Deviation 10.83
AST-12025-Hydroxyvitamin D LevelsWeek 12024.45 ng/mLStandard Deviation 11.315
AST-12025-Hydroxyvitamin D LevelsWeek 2421.70 ng/mLStandard Deviation 10.166
AST-12025-Hydroxyvitamin D LevelsWeek 13225.50 ng/mLStandard Deviation 11.083
AST-12025-Hydroxyvitamin D LevelsEarly Term/ Discontinuation22.18 ng/mLStandard Deviation 13.112
AST-12025-Hydroxyvitamin D LevelsWeek 16828.87 ng/mLStandard Deviation 12.654
AST-12025-Hydroxyvitamin D LevelsFinal Visit24.62 ng/mLStandard Deviation 11.311
AST-12025-Hydroxyvitamin D LevelsWeek 3621.72 ng/mLStandard Deviation 10.441
Placebo25-Hydroxyvitamin D LevelsFinal Visit24.03 ng/mLStandard Deviation 11.099
Placebo25-Hydroxyvitamin D LevelsWeek 7221.58 ng/mLStandard Deviation 11.225
Placebo25-Hydroxyvitamin D LevelsWeek 13222.33 ng/mLStandard Deviation 11.377
Placebo25-Hydroxyvitamin D LevelsWeek 14421.06 ng/mLStandard Deviation 9.96
Placebo25-Hydroxyvitamin D LevelsWeek 15621.46 ng/mLStandard Deviation 10.506
Placebo25-Hydroxyvitamin D LevelsWeek 16823.91 ng/mLStandard Deviation 11.704
Placebo25-Hydroxyvitamin D LevelsBaseline20.36 ng/mLStandard Deviation 10.063
Placebo25-Hydroxyvitamin D LevelsWeek 1221.08 ng/mLStandard Deviation 10.246
Placebo25-Hydroxyvitamin D LevelsWeek 2421.28 ng/mLStandard Deviation 10.1
Placebo25-Hydroxyvitamin D LevelsWeek 3621.00 ng/mLStandard Deviation 9.766
Placebo25-Hydroxyvitamin D LevelsWeek 4820.57 ng/mLStandard Deviation 10.489
Placebo25-Hydroxyvitamin D LevelsWeek 6020.36 ng/mLStandard Deviation 10.25
Placebo25-Hydroxyvitamin D LevelsWeek 8422.30 ng/mLStandard Deviation 10.728
Placebo25-Hydroxyvitamin D LevelsWeek 9621.83 ng/mLStandard Deviation 10.463
Placebo25-Hydroxyvitamin D LevelsWeek 10822.17 ng/mLStandard Deviation 11.535
Placebo25-Hydroxyvitamin D LevelsWeek 12022.55 ng/mLStandard Deviation 12.332
Placebo25-Hydroxyvitamin D LevelsEarly Term/ Discontinuation21.32 ng/mLStandard Deviation 10.752
Placebo25-Hydroxyvitamin D LevelsWeek 18025.72 ng/mLStandard Deviation 8.827
Secondary

Number of Participants Who Developed a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death)

Time frame: approximately 42 months

Population: ITT (censored at last contact)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AST-120Number of Participants Who Developed a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death)204 Participants
PlaceboNumber of Participants Who Developed a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death)217 Participants
Secondary

Serum Folate Levels

Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 420.569 Days), Final Visit (Mean: 909.848 Days)

Population: Safety population. This analysis was performed using the data only from patients who had the data at each visit.

ArmMeasureGroupValue (MEAN)Dispersion
AST-120Serum Folate LevelsBaseline15.51 ng/mLStandard Deviation 28.3
AST-120Serum Folate LevelsWeek 1213.46 ng/mLStandard Deviation 23.247
AST-120Serum Folate LevelsWeek 2413.79 ng/mLStandard Deviation 28.539
AST-120Serum Folate LevelsWeek 3613.35 ng/mLStandard Deviation 24.059
AST-120Serum Folate LevelsWeek 4813.84 ng/mLStandard Deviation 24.193
AST-120Serum Folate LevelsWeek 6013.25 ng/mLStandard Deviation 20.655
AST-120Serum Folate LevelsWeek 7212.78 ng/mLStandard Deviation 21.37
AST-120Serum Folate LevelsWeek 8412.67 ng/mLStandard Deviation 19.767
AST-120Serum Folate LevelsWeek 9613.27 ng/mLStandard Deviation 18.484
AST-120Serum Folate LevelsWeek 10812.76 ng/mLStandard Deviation 18.758
AST-120Serum Folate LevelsWeek 12012.34 ng/mLStandard Deviation 13.152
AST-120Serum Folate LevelsWeek 13212.13 ng/mLStandard Deviation 12.813
AST-120Serum Folate LevelsWeek 14414.26 ng/mLStandard Deviation 31.355
AST-120Serum Folate LevelsWeek 15612.12 ng/mLStandard Deviation 12.259
AST-120Serum Folate LevelsWeek 16813.90 ng/mLStandard Deviation 16.225
AST-120Serum Folate LevelsWeek 18016.63 ng/mLStandard Deviation 17.402
AST-120Serum Folate LevelsEarly Term/ Discontinuation12.28 ng/mLStandard Deviation 18.101
AST-120Serum Folate LevelsFinal Visit13.62 ng/mLStandard Deviation 24.37
PlaceboSerum Folate LevelsWeek 15610.04 ng/mLStandard Deviation 10.91
PlaceboSerum Folate LevelsBaseline18.87 ng/mLStandard Deviation 37.577
PlaceboSerum Folate LevelsWeek 10817.10 ng/mLStandard Deviation 42.133
PlaceboSerum Folate LevelsWeek 1218.57 ng/mLStandard Deviation 38.5
PlaceboSerum Folate LevelsFinal Visit18.36 ng/mLStandard Deviation 42.611
PlaceboSerum Folate LevelsWeek 2417.44 ng/mLStandard Deviation 39.95
PlaceboSerum Folate LevelsWeek 12018.93 ng/mLStandard Deviation 46.884
PlaceboSerum Folate LevelsWeek 3616.61 ng/mLStandard Deviation 34.428
PlaceboSerum Folate LevelsWeek 16817.62 ng/mLStandard Deviation 31.941
PlaceboSerum Folate LevelsWeek 4818.16 ng/mLStandard Deviation 40.329
PlaceboSerum Folate LevelsWeek 13214.08 ng/mLStandard Deviation 36.549
PlaceboSerum Folate LevelsWeek 6017.57 ng/mLStandard Deviation 40.427
PlaceboSerum Folate LevelsEarly Term/ Discontinuation23.21 ng/mLStandard Deviation 35.035
PlaceboSerum Folate LevelsWeek 7217.76 ng/mLStandard Deviation 38.679
PlaceboSerum Folate LevelsWeek 1449.93 ng/mLStandard Deviation 9.423
PlaceboSerum Folate LevelsWeek 8414.34 ng/mLStandard Deviation 26.514
PlaceboSerum Folate LevelsWeek 18013.45 ng/mLStandard Deviation 14.884
PlaceboSerum Folate LevelsWeek 9617.20 ng/mLStandard Deviation 37.621
Secondary

Vitamin A Levels

Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 430.293 Days), Final Visit (Mean: 908.486 Days)

Population: Safety population. This analysis was performed using the data only from patients who had the data at each visit.

ArmMeasureGroupValue (MEAN)Dispersion
AST-120Vitamin A LevelsWeek 1081231.2 ng/mLStandard Deviation 397.68
AST-120Vitamin A LevelsWeek 481117.0 ng/mLStandard Deviation 380.72
AST-120Vitamin A LevelsWeek 1201240.8 ng/mLStandard Deviation 387.79
AST-120Vitamin A LevelsWeek 601162.6 ng/mLStandard Deviation 373.49
AST-120Vitamin A LevelsWeek 1321253.2 ng/mLStandard Deviation 376.03
AST-120Vitamin A LevelsWeek 241106.0 ng/mLStandard Deviation 371.04
AST-120Vitamin A LevelsWeek 1441324.6 ng/mLStandard Deviation 567.01
AST-120Vitamin A LevelsWeek 721157.6 ng/mLStandard Deviation 397.82
AST-120Vitamin A LevelsWeek 1561196.3 ng/mLStandard Deviation 456.16
AST-120Vitamin A LevelsWeek 121098.9 ng/mLStandard Deviation 376.33
AST-120Vitamin A LevelsWeek 1681265.0 ng/mLStandard Deviation 478.26
AST-120Vitamin A LevelsWeek 841225.6 ng/mLStandard Deviation 418.23
AST-120Vitamin A LevelsWeek 1801243.4 ng/mLStandard Deviation 454.73
AST-120Vitamin A LevelsWeek 361118.4 ng/mLStandard Deviation 382.22
AST-120Vitamin A LevelsEarly Term/ Discontinuation1231.2 ng/mLStandard Deviation 442.79
AST-120Vitamin A LevelsWeek 961219.5 ng/mLStandard Deviation 419.49
AST-120Vitamin A LevelsFinal Visit1223.3 ng/mLStandard Deviation 393.07
AST-120Vitamin A LevelsBaseline1143.6 ng/mLStandard Deviation 398.42
PlaceboVitamin A LevelsFinal Visit1274.5 ng/mLStandard Deviation 350.67
PlaceboVitamin A LevelsBaseline1159.4 ng/mLStandard Deviation 404.85
PlaceboVitamin A LevelsWeek 121182.9 ng/mLStandard Deviation 411.38
PlaceboVitamin A LevelsWeek 241180.5 ng/mLStandard Deviation 385.83
PlaceboVitamin A LevelsWeek 361201.6 ng/mLStandard Deviation 401.03
PlaceboVitamin A LevelsWeek 601242.3 ng/mLStandard Deviation 421.19
PlaceboVitamin A LevelsWeek 721243.5 ng/mLStandard Deviation 416.84
PlaceboVitamin A LevelsWeek 841249.3 ng/mLStandard Deviation 379.41
PlaceboVitamin A LevelsWeek 961267.8 ng/mLStandard Deviation 376.38
PlaceboVitamin A LevelsWeek 1081266.6 ng/mLStandard Deviation 427.25
PlaceboVitamin A LevelsWeek 1201198.7 ng/mLStandard Deviation 388.77
PlaceboVitamin A LevelsWeek 1321234.2 ng/mLStandard Deviation 365.55
PlaceboVitamin A LevelsWeek 1441204.5 ng/mLStandard Deviation 414.34
PlaceboVitamin A LevelsWeek 1561193.0 ng/mLStandard Deviation 389.27
PlaceboVitamin A LevelsWeek 1681363.7 ng/mLStandard Deviation 348.93
PlaceboVitamin A LevelsWeek 1801147.8 ng/mLStandard Deviation 254.3
PlaceboVitamin A LevelsEarly Term/ Discontinuation1269.4 ng/mLStandard Deviation 425.09
PlaceboVitamin A LevelsWeek 481196.7 ng/mLStandard Deviation 399.97
Secondary

Vitamin B12 Levels

Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 425.112 Days), Final Visit (Mean: 910.988 Days)

Population: Safety population. This analysis was performed using the data only from patients who had the data at each visit.

ArmMeasureGroupValue (MEAN)Dispersion
AST-120Vitamin B12 LevelsWeek 48455.2 pg/mLStandard Deviation 371.17
AST-120Vitamin B12 LevelsWeek 108700.2 pg/mLStandard Deviation 2110.74
AST-120Vitamin B12 LevelsWeek 12497.6 pg/mLStandard Deviation 1466.88
AST-120Vitamin B12 LevelsWeek 120509.9 pg/mLStandard Deviation 726.72
AST-120Vitamin B12 LevelsWeek 60444.4 pg/mLStandard Deviation 332.65
AST-120Vitamin B12 LevelsWeek 132657.7 pg/mLStandard Deviation 1428.09
AST-120Vitamin B12 LevelsWeek 36631.8 pg/mLStandard Deviation 2079.77
AST-120Vitamin B12 LevelsWeek 144416.3 pg/mLStandard Deviation 211.52
AST-120Vitamin B12 LevelsWeek 72601.6 pg/mLStandard Deviation 1882.39
AST-120Vitamin B12 LevelsWeek 156601.5 pg/mLStandard Deviation 744.06
AST-120Vitamin B12 LevelsWeek 24608.4 pg/mLStandard Deviation 2016.76
AST-120Vitamin B12 LevelsWeek 168552.7 pg/mLStandard Deviation 570.85
AST-120Vitamin B12 LevelsWeek 84465.2 pg/mLStandard Deviation 637.01
AST-120Vitamin B12 LevelsWeek 180494.5 pg/mLStandard Deviation 389.57
AST-120Vitamin B12 LevelsEarly Term/ Discontinuation1186.2 pg/mLStandard Deviation 4148.5
AST-120Vitamin B12 LevelsWeek 96444.8 pg/mLStandard Deviation 364.9
AST-120Vitamin B12 LevelsFinal Visit764.2 pg/mLStandard Deviation 2392.88
AST-120Vitamin B12 LevelsBaseline651.7 pg/mLStandard Deviation 1961.13
PlaceboVitamin B12 LevelsFinal Visit505.5 pg/mLStandard Deviation 1063.91
PlaceboVitamin B12 LevelsBaseline747.9 pg/mLStandard Deviation 2521.02
PlaceboVitamin B12 LevelsWeek 12464.3 pg/mLStandard Deviation 650.01
PlaceboVitamin B12 LevelsWeek 24681.0 pg/mLStandard Deviation 2127.01
PlaceboVitamin B12 LevelsWeek 36618.7 pg/mLStandard Deviation 2031.35
PlaceboVitamin B12 LevelsWeek 48728.4 pg/mLStandard Deviation 2412.07
PlaceboVitamin B12 LevelsWeek 60637.8 pg/mLStandard Deviation 1911.72
PlaceboVitamin B12 LevelsWeek 72741.3 pg/mLStandard Deviation 2281.81
PlaceboVitamin B12 LevelsWeek 84740.9 pg/mLStandard Deviation 2492.87
PlaceboVitamin B12 LevelsWeek 96459.5 pg/mLStandard Deviation 548.84
PlaceboVitamin B12 LevelsWeek 108505.6 pg/mLStandard Deviation 771.7
PlaceboVitamin B12 LevelsWeek 120689.1 pg/mLStandard Deviation 1864.4
PlaceboVitamin B12 LevelsWeek 132476.9 pg/mLStandard Deviation 483.88
PlaceboVitamin B12 LevelsWeek 144721.3 pg/mLStandard Deviation 1543.37
PlaceboVitamin B12 LevelsWeek 1561046.6 pg/mLStandard Deviation 3595.42
PlaceboVitamin B12 LevelsWeek 168750.2 pg/mLStandard Deviation 1385.54
PlaceboVitamin B12 LevelsWeek 1801062.7 pg/mLStandard Deviation 2386.4
PlaceboVitamin B12 LevelsEarly Term/ Discontinuation1174.8 pg/mLStandard Deviation 3403.8
Secondary

Vitamin E Levels

Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 427.067 Days), Final Visit (Mean: 908.715 Days)

Population: Safety population. This analysis was performed using the data only from patients who had the data at each visit.

ArmMeasureGroupValue (MEAN)Dispersion
AST-120Vitamin E LevelsBaseline16.55 ug/mLStandard Deviation 6.204
AST-120Vitamin E LevelsWeek 1216.59 ug/mLStandard Deviation 6.152
AST-120Vitamin E LevelsWeek 2416.87 ug/mLStandard Deviation 6.146
AST-120Vitamin E LevelsWeek 3617.32 ug/mLStandard Deviation 7.28
AST-120Vitamin E LevelsWeek 4817.12 ug/mLStandard Deviation 6.653
AST-120Vitamin E LevelsWeek 6016.60 ug/mLStandard Deviation 5.787
AST-120Vitamin E LevelsWeek 7216.79 ug/mLStandard Deviation 6.188
AST-120Vitamin E LevelsWeek 8417.13 ug/mLStandard Deviation 6.978
AST-120Vitamin E LevelsWeek 9617.42 ug/mLStandard Deviation 6.987
AST-120Vitamin E LevelsWeek 10817.27 ug/mLStandard Deviation 6.403
AST-120Vitamin E LevelsWeek 12016.95 ug/mLStandard Deviation 5.217
AST-120Vitamin E LevelsWeek 13216.81 ug/mLStandard Deviation 5.533
AST-120Vitamin E LevelsWeek 14417.11 ug/mLStandard Deviation 6.97
AST-120Vitamin E LevelsWeek 15616.64 ug/mLStandard Deviation 6.016
AST-120Vitamin E LevelsWeek 16816.64 ug/mLStandard Deviation 6.435
AST-120Vitamin E LevelsWeek 18015.57 ug/mLStandard Deviation 4.474
AST-120Vitamin E LevelsEarly Term/ Discontinuation16.32 ug/mLStandard Deviation 5.047
AST-120Vitamin E LevelsFinal Visit15.60 ug/mLStandard Deviation 5.731
PlaceboVitamin E LevelsWeek 15616.70 ug/mLStandard Deviation 6.491
PlaceboVitamin E LevelsBaseline16.29 ug/mLStandard Deviation 6.188
PlaceboVitamin E LevelsWeek 10817.03 ug/mLStandard Deviation 5.986
PlaceboVitamin E LevelsWeek 1216.94 ug/mLStandard Deviation 6.756
PlaceboVitamin E LevelsFinal Visit15.92 ug/mLStandard Deviation 6.211
PlaceboVitamin E LevelsWeek 2416.82 ug/mLStandard Deviation 6.275
PlaceboVitamin E LevelsWeek 12016.79 ug/mLStandard Deviation 5.87
PlaceboVitamin E LevelsWeek 3616.82 ug/mLStandard Deviation 6.046
PlaceboVitamin E LevelsWeek 16818.02 ug/mLStandard Deviation 6.865
PlaceboVitamin E LevelsWeek 4816.95 ug/mLStandard Deviation 6.204
PlaceboVitamin E LevelsWeek 13216.42 ug/mLStandard Deviation 6.081
PlaceboVitamin E LevelsWeek 6017.14 ug/mLStandard Deviation 6.267
PlaceboVitamin E LevelsEarly Term/ Discontinuation16.25 ug/mLStandard Deviation 6.334
PlaceboVitamin E LevelsWeek 7217.10 ug/mLStandard Deviation 6.242
PlaceboVitamin E LevelsWeek 14417.06 ug/mLStandard Deviation 6.607
PlaceboVitamin E LevelsWeek 8416.82 ug/mLStandard Deviation 5.847
PlaceboVitamin E LevelsWeek 18017.58 ug/mLStandard Deviation 5.239
PlaceboVitamin E LevelsWeek 9617.21 ug/mLStandard Deviation 6.007
Secondary

Vitamin K Levels

Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 432.942 Days), Final Visit (Mean: 910.448 Days)

Population: Safety population. This analysis was performed using the data only from patients who had the data at each visit.

ArmMeasureGroupValue (MEAN)Dispersion
AST-120Vitamin K LevelsBaseline0.663 ng/mLStandard Deviation 0.6138
AST-120Vitamin K LevelsWeek 120.651 ng/mLStandard Deviation 0.6296
AST-120Vitamin K LevelsWeek 240.655 ng/mLStandard Deviation 0.5999
AST-120Vitamin K LevelsWeek 360.730 ng/mLStandard Deviation 0.6616
AST-120Vitamin K LevelsWeek 480.626 ng/mLStandard Deviation 0.5746
AST-120Vitamin K LevelsWeek 600.695 ng/mLStandard Deviation 0.6458
AST-120Vitamin K LevelsWeek 720.703 ng/mLStandard Deviation 0.6295
AST-120Vitamin K LevelsWeek 840.775 ng/mLStandard Deviation 0.7309
AST-120Vitamin K LevelsWeek 960.723 ng/mLStandard Deviation 0.6386
AST-120Vitamin K LevelsWeek 1080.801 ng/mLStandard Deviation 0.719
AST-120Vitamin K LevelsWeek 1200.688 ng/mLStandard Deviation 0.7177
AST-120Vitamin K LevelsWeek 1320.782 ng/mLStandard Deviation 0.7253
AST-120Vitamin K LevelsWeek 1440.661 ng/mLStandard Deviation 0.6658
AST-120Vitamin K LevelsWeek 1560.685 ng/mLStandard Deviation 0.63
AST-120Vitamin K LevelsWeek 1680.822 ng/mLStandard Deviation 0.7662
AST-120Vitamin K LevelsWeek 1800.879 ng/mLStandard Deviation 0.8268
AST-120Vitamin K LevelsEarly Term / Discontinuation0.761 ng/mLStandard Deviation 0.692
AST-120Vitamin K LevelsFinal Visit0.843 ng/mLStandard Deviation 0.7197
PlaceboVitamin K LevelsWeek 1560.724 ng/mLStandard Deviation 0.657
PlaceboVitamin K LevelsBaseline0.628 ng/mLStandard Deviation 0.6023
PlaceboVitamin K LevelsWeek 1080.737 ng/mLStandard Deviation 0.7428
PlaceboVitamin K LevelsWeek 120.653 ng/mLStandard Deviation 0.606
PlaceboVitamin K LevelsFinal Visit0.814 ng/mLStandard Deviation 0.6982
PlaceboVitamin K LevelsWeek 240.658 ng/mLStandard Deviation 0.6364
PlaceboVitamin K LevelsWeek 1200.717 ng/mLStandard Deviation 0.6918
PlaceboVitamin K LevelsWeek 360.640 ng/mLStandard Deviation 0.612
PlaceboVitamin K LevelsWeek 1680.862 ng/mLStandard Deviation 0.7611
PlaceboVitamin K LevelsWeek 480.649 ng/mLStandard Deviation 0.6211
PlaceboVitamin K LevelsWeek 1320.650 ng/mLStandard Deviation 0.6832
PlaceboVitamin K LevelsWeek 600.732 ng/mLStandard Deviation 0.664
PlaceboVitamin K LevelsEarly Term / Discontinuation0.679 ng/mLStandard Deviation 0.6541
PlaceboVitamin K LevelsWeek 720.703 ng/mLStandard Deviation 0.6668
PlaceboVitamin K LevelsWeek 1440.662 ng/mLStandard Deviation 0.5824
PlaceboVitamin K LevelsWeek 840.717 ng/mLStandard Deviation 0.6631
PlaceboVitamin K LevelsWeek 1801.020 ng/mLStandard Deviation 1.0008
PlaceboVitamin K LevelsWeek 960.682 ng/mLStandard Deviation 0.6382

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026