FindTrial
Sign In

A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00500682
Enrollment
1020
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.

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 at Screening * Blood pressure \<= 160/90 mmHg at both Screening and Baseline. 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, 192, Early Term/Discontinuation (Mean: 428.615 Days), Final Visit (Mean: 947.354 Days)
Vitamin B12 LevelsBaseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.114 Days), Final Visit (Mean: 947.239 Days)
25-Hydroxyvitamin D LevelsBaseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 427.270 Days), Final Visit (Mean: 946.762 Days)
Vitamin E LevelsBaseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.056 Days), Final Visit (Mean: 946.525 Days)
Vitamin K LevelsBaseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 441.826 Days), Final Visit (Mean: 946.463 Days)
Serum Folate LevelsBaseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, Early Term/Discontinuation (Mean: 423.024 Days), Final Visit (Mean: 946.074 Days)

Countries

Argentina, Brazil, Canada, Czechia, France, Italy, Mexico, Poland, Puerto Rico, Russia, Ukraine, United States

Participant flow

Participants by arm

ArmCount
AST-120
AST-120: 9g /day (3 times a day)
510
Placebo
Placebo: 9g /day (3 times a day)
510
Total1,020

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event3729
Overall StudyDeath2516
Overall StudyLost to Follow-up1111
Overall StudyPhysician Decision610
Overall StudyPregnancy20
Overall StudyProtocol Violation13
Overall StudyReaching endpoints, Noncompliance, etc144144
Overall StudyWithdrawal by Subject8074

Baseline characteristics

CharacteristicAST-120PlaceboTotal
Age, Continuous56.5 years
STANDARD_DEVIATION 14.93
55.8 years
STANDARD_DEVIATION 14.99
56.1 years
STANDARD_DEVIATION 14.95
Sex: Female, Male
Female
195 Participants179 Participants374 Participants
Sex: Female, Male
Male
315 Participants331 Participants646 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
376 / 507382 / 509
serious
Total, serious adverse events
195 / 507184 / 509

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.178 participants
PlaceboComposite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.177 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 AE436 Participants
AST-120Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse EventsTreatment-emergent SAE195 Participants
PlaceboNumber of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse EventsTreatment-emergent AE448 Participants
PlaceboNumber of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse EventsTreatment-emergent SAE184 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, 192, Early Term/Discontinuation (Mean: 427.270 Days), Final Visit (Mean: 946.762 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 9622.18 ng/mLStandard Deviation 11.563
AST-12025-Hydroxyvitamin D LevelsWeek 1221.55 ng/mLStandard Deviation 9.988
AST-12025-Hydroxyvitamin D LevelsWeek 10821.85 ng/mLStandard Deviation 11.324
AST-12025-Hydroxyvitamin D LevelsWeek 4821.83 ng/mLStandard Deviation 10.963
AST-12025-Hydroxyvitamin D LevelsWeek 12022.15 ng/mLStandard Deviation 11.189
AST-12025-Hydroxyvitamin D LevelsBaseline22.08 ng/mLStandard Deviation 10.361
AST-12025-Hydroxyvitamin D LevelsWeek 14423.29 ng/mLStandard Deviation 11.051
AST-12025-Hydroxyvitamin D LevelsWeek 6021.78 ng/mLStandard Deviation 11.076
AST-12025-Hydroxyvitamin D LevelsWeek 15623.23 ng/mLStandard Deviation 9.857
AST-12025-Hydroxyvitamin D LevelsWeek 2421.41 ng/mLStandard Deviation 9.823
AST-12025-Hydroxyvitamin D LevelsWeek 16825.45 ng/mLStandard Deviation 12.045
AST-12025-Hydroxyvitamin D LevelsWeek 7222.23 ng/mLStandard Deviation 10.988
AST-12025-Hydroxyvitamin D LevelsWeek 18029.58 ng/mLStandard Deviation 12.985
AST-12025-Hydroxyvitamin D LevelsWeek 13222.04 ng/mLStandard Deviation 10.581
AST-12025-Hydroxyvitamin D LevelsWeek 19233.10 ng/mLStandard Deviation 6.651
AST-12025-Hydroxyvitamin D LevelsEarly Term/Discontinuation20.57 ng/mLStandard Deviation 9.958
AST-12025-Hydroxyvitamin D LevelsWeek 8421.79 ng/mLStandard Deviation 10.759
AST-12025-Hydroxyvitamin D LevelsFinal Visit25.20 ng/mLStandard Deviation 10.847
AST-12025-Hydroxyvitamin D LevelsWeek 3621.70 ng/mLStandard Deviation 10.539
Placebo25-Hydroxyvitamin D LevelsFinal Visit25.69 ng/mLStandard Deviation 9.937
Placebo25-Hydroxyvitamin D LevelsWeek 12022.45 ng/mLStandard Deviation 9.344
Placebo25-Hydroxyvitamin D LevelsBaseline22.06 ng/mLStandard Deviation 10.4
Placebo25-Hydroxyvitamin D LevelsWeek 1222.15 ng/mLStandard Deviation 10.162
Placebo25-Hydroxyvitamin D LevelsWeek 2422.13 ng/mLStandard Deviation 9.648
Placebo25-Hydroxyvitamin D LevelsWeek 3621.70 ng/mLStandard Deviation 9.926
Placebo25-Hydroxyvitamin D LevelsWeek 4822.06 ng/mLStandard Deviation 10.644
Placebo25-Hydroxyvitamin D LevelsWeek 6021.56 ng/mLStandard Deviation 10.425
Placebo25-Hydroxyvitamin D LevelsWeek 7222.29 ng/mLStandard Deviation 9.617
Placebo25-Hydroxyvitamin D LevelsWeek 8422.75 ng/mLStandard Deviation 10.528
Placebo25-Hydroxyvitamin D LevelsWeek 9622.53 ng/mLStandard Deviation 10.833
Placebo25-Hydroxyvitamin D LevelsWeek 10821.62 ng/mLStandard Deviation 10.679
Placebo25-Hydroxyvitamin D LevelsWeek 13221.83 ng/mLStandard Deviation 10.285
Placebo25-Hydroxyvitamin D LevelsWeek 14422.95 ng/mLStandard Deviation 11.046
Placebo25-Hydroxyvitamin D LevelsWeek 15623.01 ng/mLStandard Deviation 12.943
Placebo25-Hydroxyvitamin D LevelsWeek 16824.44 ng/mLStandard Deviation 11.403
Placebo25-Hydroxyvitamin D LevelsWeek 18028.10 ng/mLStandard Deviation 10.929
Placebo25-Hydroxyvitamin D LevelsEarly Term/Discontinuation22.52 ng/mLStandard Deviation 11.803
Placebo25-Hydroxyvitamin D LevelsWeek 19231.38 ng/mLStandard Deviation 9.606
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)213 Participants
PlaceboNumber of Participants Who Developed a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death)201 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: 423.024 Days), Final Visit (Mean: 946.074 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 LevelsWeek 10813.50 ng/mLStandard Deviation 18.491
AST-120Serum Folate LevelsWeek 4819.30 ng/mLStandard Deviation 44.798
AST-120Serum Folate LevelsWeek 12012.52 ng/mLStandard Deviation 16.033
AST-120Serum Folate LevelsWeek 2418.16 ng/mLStandard Deviation 34.095
AST-120Serum Folate LevelsWeek 13217.09 ng/mLStandard Deviation 45.645
AST-120Serum Folate LevelsWeek 6019.06 ng/mLStandard Deviation 41.799
AST-120Serum Folate LevelsWeek 14418.13 ng/mLStandard Deviation 41.386
AST-120Serum Folate LevelsWeek 7216.12 ng/mLStandard Deviation 32.761
AST-120Serum Folate LevelsWeek 15613.08 ng/mLStandard Deviation 13.098
AST-120Serum Folate LevelsWeek 1221.47 ng/mLStandard Deviation 46.801
AST-120Serum Folate LevelsWeek 16815.13 ng/mLStandard Deviation 12.776
AST-120Serum Folate LevelsWeek 8417.00 ng/mLStandard Deviation 30.02
AST-120Serum Folate LevelsWeek 18033.10 ng/mLStandard Deviation 19.021
AST-120Serum Folate LevelsWeek 3620.95 ng/mLStandard Deviation 47.528
AST-120Serum Folate LevelsEarly Term/Discontinuation24.43 ng/mLStandard Deviation 49.342
AST-120Serum Folate LevelsWeek 9614.47 ng/mLStandard Deviation 25.918
AST-120Serum Folate LevelsFinal Visit15.52 ng/mLStandard Deviation 26.263
AST-120Serum Folate LevelsBaseline21.70 ng/mLStandard Deviation 44.42
PlaceboSerum Folate LevelsFinal Visit22.66 ng/mLStandard Deviation 50.498
PlaceboSerum Folate LevelsBaseline21.78 ng/mLStandard Deviation 47.064
PlaceboSerum Folate LevelsWeek 1220.94 ng/mLStandard Deviation 45.093
PlaceboSerum Folate LevelsWeek 2419.46 ng/mLStandard Deviation 45.178
PlaceboSerum Folate LevelsWeek 3618.54 ng/mLStandard Deviation 41.653
PlaceboSerum Folate LevelsWeek 4821.50 ng/mLStandard Deviation 49.944
PlaceboSerum Folate LevelsWeek 7219.96 ng/mLStandard Deviation 43.951
PlaceboSerum Folate LevelsWeek 8420.95 ng/mLStandard Deviation 46.184
PlaceboSerum Folate LevelsWeek 9618.17 ng/mLStandard Deviation 36.846
PlaceboSerum Folate LevelsWeek 10819.22 ng/mLStandard Deviation 39.625
PlaceboSerum Folate LevelsWeek 12017.01 ng/mLStandard Deviation 36.733
PlaceboSerum Folate LevelsWeek 13218.85 ng/mLStandard Deviation 44.24
PlaceboSerum Folate LevelsWeek 14418.09 ng/mLStandard Deviation 39.002
PlaceboSerum Folate LevelsWeek 15615.13 ng/mLStandard Deviation 20.162
PlaceboSerum Folate LevelsWeek 16816.26 ng/mLStandard Deviation 19.734
PlaceboSerum Folate LevelsWeek 18022.23 ng/mLStandard Deviation 25.137
PlaceboSerum Folate LevelsEarly Term/Discontinuation17.14 ng/mLStandard Deviation 24.122
PlaceboSerum Folate LevelsWeek 6019.72 ng/mLStandard Deviation 45.119
Secondary

Vitamin A Levels

Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.615 Days), Final Visit (Mean: 947.354 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 601199.2 ng/mLStandard Deviation 388.36
AST-120Vitamin A LevelsWeek 1201188.8 ng/mLStandard Deviation 357.58
AST-120Vitamin A LevelsWeek 361148.1 ng/mLStandard Deviation 385.9
AST-120Vitamin A LevelsWeek 1321273.5 ng/mLStandard Deviation 416.43
AST-120Vitamin A LevelsWeek 721216.0 ng/mLStandard Deviation 368.58
AST-120Vitamin A LevelsWeek 1441305.0 ng/mLStandard Deviation 379.81
AST-120Vitamin A LevelsWeek 241151.5 ng/mLStandard Deviation 382.4
AST-120Vitamin A LevelsWeek 1561255.6 ng/mLStandard Deviation 323.72
AST-120Vitamin A LevelsWeek 841252.1 ng/mLStandard Deviation 406.11
AST-120Vitamin A LevelsWeek 1681244.6 ng/mLStandard Deviation 275.57
AST-120Vitamin A LevelsWeek 481156.2 ng/mLStandard Deviation 367.71
AST-120Vitamin A LevelsWeek 1801176.5 ng/mLStandard Deviation 342.14
AST-120Vitamin A LevelsWeek 961240.2 ng/mLStandard Deviation 367.21
AST-120Vitamin A LevelsWeek 1921253.0 ng/mLStandard Deviation 340.63
AST-120Vitamin A LevelsWeek 121142.4 ng/mLStandard Deviation 374.14
AST-120Vitamin A LevelsEarly Term/Discontinuation1167.2 ng/mLStandard Deviation 401.08
AST-120Vitamin A LevelsWeek 1081222.1 ng/mLStandard Deviation 367.46
AST-120Vitamin A LevelsFinal Visit1266.9 ng/mLStandard Deviation 357.06
AST-120Vitamin A LevelsBaseline1145.3 ng/mLStandard Deviation 356.67
PlaceboVitamin A LevelsFinal Visit1320.1 ng/mLStandard Deviation 444.09
PlaceboVitamin A LevelsBaseline1164.2 ng/mLStandard Deviation 387.08
PlaceboVitamin A LevelsWeek 121177.9 ng/mLStandard Deviation 404.21
PlaceboVitamin A LevelsWeek 241193.6 ng/mLStandard Deviation 363.36
PlaceboVitamin A LevelsWeek 361215.1 ng/mLStandard Deviation 406.78
PlaceboVitamin A LevelsWeek 481210.1 ng/mLStandard Deviation 396.91
PlaceboVitamin A LevelsWeek 601232.1 ng/mLStandard Deviation 419.86
PlaceboVitamin A LevelsWeek 721265.5 ng/mLStandard Deviation 428.28
PlaceboVitamin A LevelsWeek 841292.8 ng/mLStandard Deviation 435.8
PlaceboVitamin A LevelsWeek 961314.8 ng/mLStandard Deviation 433.7
PlaceboVitamin A LevelsWeek 1081305.7 ng/mLStandard Deviation 421.64
PlaceboVitamin A LevelsWeek 1201234.7 ng/mLStandard Deviation 397.81
PlaceboVitamin A LevelsWeek 1321284.1 ng/mLStandard Deviation 411.37
PlaceboVitamin A LevelsWeek 1441277.9 ng/mLStandard Deviation 336.23
PlaceboVitamin A LevelsWeek 1561174.8 ng/mLStandard Deviation 347.46
PlaceboVitamin A LevelsWeek 1681185.9 ng/mLStandard Deviation 402
PlaceboVitamin A LevelsWeek 1801203.5 ng/mLStandard Deviation 271.98
PlaceboVitamin A LevelsWeek 1921189.3 ng/mLStandard Deviation 152.33
PlaceboVitamin A LevelsEarly Term/Discontinuation1191.4 ng/mLStandard Deviation 457.79
Secondary

Vitamin B12 Levels

Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.114 Days), Final Visit (Mean: 947.239 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 12597.3 pg/mLStandard Deviation 1824.74
AST-120Vitamin B12 LevelsWeek 120590.0 pg/mLStandard Deviation 1968.53
AST-120Vitamin B12 LevelsWeek 60494.2 pg/mLStandard Deviation 534.92
AST-120Vitamin B12 LevelsWeek 132923.7 pg/mLStandard Deviation 3358.51
AST-120Vitamin B12 LevelsBaseline688.1 pg/mLStandard Deviation 1881.58
AST-120Vitamin B12 LevelsWeek 144460.5 pg/mLStandard Deviation 291.19
AST-120Vitamin B12 LevelsWeek 72545.9 pg/mLStandard Deviation 1268.5
AST-120Vitamin B12 LevelsWeek 156476.3 pg/mLStandard Deviation 285.02
AST-120Vitamin B12 LevelsWeek 24554.2 pg/mLStandard Deviation 1654.52
AST-120Vitamin B12 LevelsWeek 168563.9 pg/mLStandard Deviation 528.25
AST-120Vitamin B12 LevelsWeek 84497.6 pg/mLStandard Deviation 923.15
AST-120Vitamin B12 LevelsWeek 180564.2 pg/mLStandard Deviation 254.57
AST-120Vitamin B12 LevelsWeek 36500.6 pg/mLStandard Deviation 568.44
AST-120Vitamin B12 LevelsWeek 192489.0 pg/mLStandard Deviation 306
AST-120Vitamin B12 LevelsWeek 96646.6 pg/mLStandard Deviation 2012.14
AST-120Vitamin B12 LevelsEarly Term/Discontinuation935.7 pg/mLStandard Deviation 2400.94
AST-120Vitamin B12 LevelsWeek 48530.6 pg/mLStandard Deviation 759.54
AST-120Vitamin B12 LevelsFinal Visit626.7 pg/mLStandard Deviation 1464.99
AST-120Vitamin B12 LevelsWeek 108544.1 pg/mLStandard Deviation 1564.38
PlaceboVitamin B12 LevelsFinal Visit747.1 pg/mLStandard Deviation 2495.49
PlaceboVitamin B12 LevelsBaseline620.5 pg/mLStandard Deviation 1630.87
PlaceboVitamin B12 LevelsWeek 12570.0 pg/mLStandard Deviation 1347.75
PlaceboVitamin B12 LevelsWeek 36581.6 pg/mLStandard Deviation 1316.46
PlaceboVitamin B12 LevelsWeek 48500.2 pg/mLStandard Deviation 940.36
PlaceboVitamin B12 LevelsWeek 60704.9 pg/mLStandard Deviation 2338.15
PlaceboVitamin B12 LevelsWeek 72661.8 pg/mLStandard Deviation 2014.14
PlaceboVitamin B12 LevelsWeek 84543.1 pg/mLStandard Deviation 1246.14
PlaceboVitamin B12 LevelsWeek 96799.6 pg/mLStandard Deviation 2767.12
PlaceboVitamin B12 LevelsWeek 108682.2 pg/mLStandard Deviation 1947.45
PlaceboVitamin B12 LevelsWeek 120638.4 pg/mLStandard Deviation 1993.9
PlaceboVitamin B12 LevelsWeek 132714.2 pg/mLStandard Deviation 2262.71
PlaceboVitamin B12 LevelsWeek 144472.6 pg/mLStandard Deviation 283.43
PlaceboVitamin B12 LevelsWeek 156586.3 pg/mLStandard Deviation 811.97
PlaceboVitamin B12 LevelsWeek 168493.7 pg/mLStandard Deviation 342.53
PlaceboVitamin B12 LevelsWeek 180653.8 pg/mLStandard Deviation 694.69
PlaceboVitamin B12 LevelsWeek 192974.0 pg/mLStandard Deviation 898.28
PlaceboVitamin B12 LevelsEarly Term/Discontinuation953.5 pg/mLStandard Deviation 2914.4
PlaceboVitamin B12 LevelsWeek 24483.7 pg/mLStandard Deviation 536.3
Secondary

Vitamin E Levels

Time frame: Baseline, Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, Early Term/Discontinuation (Mean: 428.056 Days), Final Visit (Mean: 946.525 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 LevelsWeek 6017.77 ug/mLStandard Deviation 7.376
AST-120Vitamin E LevelsWeek 12018.18 ug/mLStandard Deviation 7.293
AST-120Vitamin E LevelsWeek 3617.42 ug/mLStandard Deviation 6.474
AST-120Vitamin E LevelsWeek 13218.71 ug/mLStandard Deviation 7.926
AST-120Vitamin E LevelsWeek 7217.50 ug/mLStandard Deviation 6.683
AST-120Vitamin E LevelsWeek 14418.02 ug/mLStandard Deviation 6.653
AST-120Vitamin E LevelsWeek 2417.55 ug/mLStandard Deviation 7.237
AST-120Vitamin E LevelsWeek 15617.59 ug/mLStandard Deviation 5.937
AST-120Vitamin E LevelsWeek 8417.70 ug/mLStandard Deviation 6.779
AST-120Vitamin E LevelsWeek 16816.60 ug/mLStandard Deviation 5.946
AST-120Vitamin E LevelsWeek 4817.58 ug/mLStandard Deviation 7.04
AST-120Vitamin E LevelsWeek 18015.52 ug/mLStandard Deviation 4.696
AST-120Vitamin E LevelsWeek 9617.24 ug/mLStandard Deviation 6.51
AST-120Vitamin E LevelsWeek 19214.00 ug/mLStandard Deviation 3.568
AST-120Vitamin E LevelsWeek 1217.30 ug/mLStandard Deviation 6.88
AST-120Vitamin E LevelsEarly Term/Discontinuation15.72 ug/mLStandard Deviation 5.512
AST-120Vitamin E LevelsWeek 10817.60 ug/mLStandard Deviation 6.58
AST-120Vitamin E LevelsFinal Visit17.14 ug/mLStandard Deviation 7.356
AST-120Vitamin E LevelsBaseline17.49 ug/mLStandard Deviation 7.554
PlaceboVitamin E LevelsFinal Visit16.03 ug/mLStandard Deviation 5.606
PlaceboVitamin E LevelsBaseline16.95 ug/mLStandard Deviation 6.923
PlaceboVitamin E LevelsWeek 1216.44 ug/mLStandard Deviation 6.08
PlaceboVitamin E LevelsWeek 2417.08 ug/mLStandard Deviation 6.56
PlaceboVitamin E LevelsWeek 3617.22 ug/mLStandard Deviation 6.445
PlaceboVitamin E LevelsWeek 4817.31 ug/mLStandard Deviation 6.544
PlaceboVitamin E LevelsWeek 6017.70 ug/mLStandard Deviation 6.88
PlaceboVitamin E LevelsWeek 7217.07 ug/mLStandard Deviation 6.119
PlaceboVitamin E LevelsWeek 8417.27 ug/mLStandard Deviation 6.44
PlaceboVitamin E LevelsWeek 9617.28 ug/mLStandard Deviation 6.48
PlaceboVitamin E LevelsWeek 10817.07 ug/mLStandard Deviation 6.126
PlaceboVitamin E LevelsWeek 12017.17 ug/mLStandard Deviation 6.416
PlaceboVitamin E LevelsWeek 13216.52 ug/mLStandard Deviation 5.407
PlaceboVitamin E LevelsWeek 14416.47 ug/mLStandard Deviation 6.805
PlaceboVitamin E LevelsWeek 15617.21 ug/mLStandard Deviation 7.081
PlaceboVitamin E LevelsWeek 16818.00 ug/mLStandard Deviation 8.052
PlaceboVitamin E LevelsWeek 18015.17 ug/mLStandard Deviation 7.808
PlaceboVitamin E LevelsWeek 19216.45 ug/mLStandard Deviation 5.341
PlaceboVitamin E LevelsEarly Term/Discontinuation15.58 ug/mLStandard Deviation 6.2
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: 441.826 Days), Final Visit (Mean: 946.463 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 LevelsWeek 1080.802 ng/mLStandard Deviation 0.6797
AST-120Vitamin K LevelsWeek 480.763 ng/mLStandard Deviation 0.663
AST-120Vitamin K LevelsWeek 1200.768 ng/mLStandard Deviation 0.6708
AST-120Vitamin K LevelsWeek 240.705 ng/mLStandard Deviation 0.6006
AST-120Vitamin K LevelsWeek 1320.824 ng/mLStandard Deviation 0.7655
AST-120Vitamin K LevelsWeek 600.761 ng/mLStandard Deviation 0.6868
AST-120Vitamin K LevelsWeek 1440.882 ng/mLStandard Deviation 0.763
AST-120Vitamin K LevelsWeek 120.752 ng/mLStandard Deviation 0.6601
AST-120Vitamin K LevelsWeek 1560.754 ng/mLStandard Deviation 0.6129
AST-120Vitamin K LevelsWeek 720.823 ng/mLStandard Deviation 0.7291
AST-120Vitamin K LevelsWeek 1680.858 ng/mLStandard Deviation 0.6494
AST-120Vitamin K LevelsWeek 360.739 ng/mLStandard Deviation 0.6726
AST-120Vitamin K LevelsWeek 1800.850 ng/mLStandard Deviation 0.7162
AST-120Vitamin K LevelsWeek 840.780 ng/mLStandard Deviation 0.7174
AST-120Vitamin K LevelsEarly Term/Discontinuation0.735 ng/mLStandard Deviation 0.7523
AST-120Vitamin K LevelsWeek 960.809 ng/mLStandard Deviation 0.7156
AST-120Vitamin K LevelsFinal Visit0.971 ng/mLStandard Deviation 0.7657
AST-120Vitamin K LevelsBaseline0.711 ng/mLStandard Deviation 0.6276
PlaceboVitamin K LevelsFinal Visit0.844 ng/mLStandard Deviation 0.6784
PlaceboVitamin K LevelsBaseline0.721 ng/mLStandard Deviation 0.6308
PlaceboVitamin K LevelsWeek 120.769 ng/mLStandard Deviation 0.6887
PlaceboVitamin K LevelsWeek 240.706 ng/mLStandard Deviation 0.6238
PlaceboVitamin K LevelsWeek 360.748 ng/mLStandard Deviation 0.663
PlaceboVitamin K LevelsWeek 480.704 ng/mLStandard Deviation 0.6491
PlaceboVitamin K LevelsWeek 600.778 ng/mLStandard Deviation 0.7247
PlaceboVitamin K LevelsWeek 720.722 ng/mLStandard Deviation 0.6489
PlaceboVitamin K LevelsWeek 960.768 ng/mLStandard Deviation 0.6867
PlaceboVitamin K LevelsWeek 1080.768 ng/mLStandard Deviation 0.7119
PlaceboVitamin K LevelsWeek 1200.814 ng/mLStandard Deviation 0.7119
PlaceboVitamin K LevelsWeek 1320.760 ng/mLStandard Deviation 0.574
PlaceboVitamin K LevelsWeek 1440.780 ng/mLStandard Deviation 0.6052
PlaceboVitamin K LevelsWeek 1560.816 ng/mLStandard Deviation 0.6822
PlaceboVitamin K LevelsWeek 1681.031 ng/mLStandard Deviation 0.8805
PlaceboVitamin K LevelsWeek 1800.970 ng/mLStandard Deviation 0.9033
PlaceboVitamin K LevelsEarly Term/Discontinuation0.686 ng/mLStandard Deviation 0.5772
PlaceboVitamin K LevelsWeek 840.725 ng/mLStandard Deviation 0.6869

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