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

Sponsor

Mitsubishi Tanabe Pharma Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00500682

Collaborator

Kureha Corporation (Industry)

1,020

Enrollment

105

Locations

Arms

Duration (Months)

9.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Drug: Placebo Drug: AST-120	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1020 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo 9g /day (3 times a day)
Experimental: AST-120	Drug: AST-120 9g /day (3 times a day)

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Drug: Placebo

9g /day (3 times a day)

Experimental: AST-120

Drug: AST-120

9g /day (3 times a day)

Outcome Measures

Primary Outcome Measures

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 Events [Approximately 42 months]

Secondary Outcome Measures

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 Levels [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)]
Vitamin B12 Levels [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)]
25-Hydroxyvitamin D Levels [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)]
Vitamin E Levels [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)]
Vitamin K Levels [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)]
Serum Folate Levels [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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Phoenix	Arizona	United States
2	Little Rock	Arkansas	United States
3	Alhambra	California	United States
4	Covina	California	United States
5	Glendale	California	United States
6	Los Angeles	California	United States
7	Stamford	Connecticut	United States
8	Washington	District of Columbia	United States
9	Hudson	Florida	United States
10	Miami	Florida	United States
11	Ocala	Florida	United States
12	Orlando	Florida	United States
13	Pembroke Pines	Florida	United States
14	Spring Hill	Florida	United States
15	Tampa	Florida	United States
16	Winter Park	Florida	United States
17	Kansas City	Kansas	United States
18	New Orleans	Louisiana	United States
19	Shreveport	Louisiana	United States
20	Ypsilanti	Michigan	United States
21	Kansas City	Missouri	United States
22	Saint Louis	Missouri	United States
23	Camden	New Jersey	United States
24	Eatontown	New Jersey	United States
25	Port Washington	New York	United States
26	Springfield Gardens	New York	United States
27	Asheville	North Carolina	United States
28	Cincinnati	Ohio	United States
29	Dayton	Ohio	United States
30	Toledo	Ohio	United States
31	Portland	Oregon	United States
32	Philadelphia	Pennsylvania	United States
33	Pittsburgh	Pennsylvania	United States
34	Rock Hill	South Carolina	United States
35	Nashville	Tennessee	United States
36	Arlington	Texas	United States
37	Dallas	Texas	United States
38	Houston	Texas	United States
39	San Antonio	Texas	United States
40	Appleton	Wisconsin	United States
41	Oshkosh	Wisconsin	United States
42	Buenos Aires		Argentina
43	Cordoba		Argentina
44	San Luis		Argentina
45	San Pedro		Argentina
46	Tucuman		Argentina
47	Barao Geraldo-Campinas		Brazil
48	Belo Horizonte Minas Gerais		Brazil
49	Juiz de Fora		Brazil
50	Porto Alegre		Brazil
51	Rio de Janeiro		Brazil
52	São Paulo		Brazil
53	Taubaté		Brazil
54	Winnipeg	Manitoba	Canada
55	Brampton	Ontario	Canada
56	Kitzhener	Ontario	Canada
57	Oakville	Ontario	Canada
58	Scarborough	Ontario	Canada
59	Toronto	Ontario	Canada
60	Montreal	Quebec	Canada
61	Ceske Budejovice		Czechia
62	Jihlava		Czechia
63	Ostrava - Poruba		Czechia
64	Praha		Czechia
65	Tabor		Czechia
66	Grenoble		France
67	Lyon		France
68	Nantes		France
69	Saint-Lo		France
70	Bologna		Italy
71	Brescia		Italy
72	Como		Italy
73	Pavia		Italy
74	Aguascalientes		Mexico
75	Mexico City		Mexico
76	Tijuana		Mexico
77	Gdansk		Poland
78	Szczecin		Poland
79	Torun		Poland
80	Warszawa		Poland
81	Caguas		Puerto Rico
82	Bamaul		Russian Federation
83	Ekaterinburg		Russian Federation
84	Kazan		Russian Federation
85	Krasnodar		Russian Federation
86	Moscow		Russian Federation
87	Nizhniy Novgorod		Russian Federation
88	Novosibirsk		Russian Federation
89	Pyatigorsk		Russian Federation
90	Ryazan		Russian Federation
91	Saratov		Russian Federation
92	Smolensk		Russian Federation
93	Sochi		Russian Federation
94	St. Petersburg		Russian Federation
95	Stavropol		Russian Federation
96	Chernovtsy		Ukraine
97	Dnipropetrovsk		Ukraine
98	Donetsk		Ukraine
99	Ivano-Frankivsk		Ukraine
100	Kharkov		Ukraine
101	Kiev		Ukraine
102	Odessa		Ukraine
103	Uzhgorod		Ukraine
104	Vinnitsa		Ukraine
105	Zhytomir		Ukraine

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation
Kureha Corporation

Investigators

Principal Investigator: Professor, Information at Mitsubishi Tanabe Pharma Development America, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mitsubishi Tanabe Pharma Corporation

ClinicalTrials.gov Identifier:

NCT00500682

Other Study ID Numbers:

KRM-306

First Posted:

Jul 13, 2007

Last Update Posted:

Jun 7, 2022

Last Verified:

May 1, 2022

Keywords provided by Mitsubishi Tanabe Pharma Corporation

Kidney Diseases

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	AST-120	Placebo
Arm/Group Description	AST-120: 9g /day (3 times a day)	Placebo: 9g /day (3 times a day)
Period Title: Overall Study
STARTED	510	510
COMPLETED	204	223
NOT COMPLETED	306	287

Baseline Characteristics

Arm/Group Title	AST-120	Placebo	Total
Arm/Group Description	AST-120: 9g /day (3 times a day)	Placebo: 9g /day (3 times a day)	Total of all reporting groups
Overall Participants	510	510	1020
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.5 (14.93)	55.8 (14.99)	56.1 (14.95)
Sex: Female, Male (Count of Participants)
Female	195 38.2%	179 35.1%	374 36.7%
Male	315 61.8%	331 64.9%	646 63.3%

Outcome Measures

1. Primary Outcome

Title	Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported.
Description
Time Frame	Beyond Week 48, a 12-week visit cycle continued until the end of the study or until individual patients reached an endpoint

Outcome Measure Data

Analysis Population Description
ITT (censored at last contact)

Arm/Group Title	AST-120	Placebo
Arm/Group Description	AST-120: 9g /day (3 times a day)	Placebo: 9g /day (3 times a day)
Measure Participants	500	502
Number [participants]	178 34.9%	177 34.7%

2. Primary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events
Description
Time Frame	Approximately 42 months

Outcome Measure Data

Analysis Population Description
Safety population

Arm/Group Title	AST-120	Placebo
Arm/Group Description	AST-120: 9g /day (3 times a day)	Placebo: 9g /day (3 times a day)
Measure Participants	507	509
Treatment-emergent AE	436 85.5%	448 87.8%
Treatment-emergent SAE	195 38.2%	184 36.1%

3. Secondary Outcome

Title	Number of Participants Who Developed a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death)
Description
Time Frame	Approximately 42 months

Outcome Measure Data

Analysis Population Description
ITT (censored at last contact)

Arm/Group Title	AST-120	Placebo
Arm/Group Description	AST-120: 9g /day (3 times a day)	Placebo: 9g /day (3 times a day)
Measure Participants	500	502
Count of Participants [Participants]	213 41.8%	201 39.4%

4. Secondary Outcome

Title	Vitamin A Levels
Description
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)

Outcome Measure Data

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

Arm/Group Title	AST-120	Placebo
Arm/Group Description	AST-120: 9g /day (3 times a day)	Placebo: 9g /day (3 times a day)
Measure Participants	507	509
Baseline	1145.3 (356.67)	1164.2 (387.08)
Week 12	1142.4 (374.14)	1177.9 (404.21)
Week 24	1151.5 (382.40)	1193.6 (363.36)
Week 36	1148.1 (385.90)	1215.1 (406.78)
Week 48	1156.2 (367.71)	1210.1 (396.91)
Week 60	1199.2 (388.36)	1232.1 (419.86)
Week 72	1216.0 (368.58)	1265.5 (428.28)
Week 84	1252.1 (406.11)	1292.8 (435.80)
Week 96	1240.2 (367.21)	1314.8 (433.70)
Week 108	1222.1 (367.46)	1305.7 (421.64)
Week 120	1188.8 (357.58)	1234.7 (397.81)
Week 132	1273.5 (416.43)	1284.1 (411.37)
Week 144	1305.0 (379.81)	1277.9 (336.23)
Week 156	1255.6 (323.72)	1174.8 (347.46)
Week 168	1244.6 (275.57)	1185.9 (402.00)
Week 180	1176.5 (342.14)	1203.5 (271.98)
Week 192	1253.0 (340.63)	1189.3 (152.33)
Early Term/Discontinuation	1167.2 (401.08)	1191.4 (457.79)
Final Visit	1266.9 (357.06)	1320.1 (444.09)

5. Secondary Outcome

Title	Vitamin B12 Levels
Description
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)

Outcome Measure Data

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

Arm/Group Title	AST-120	Placebo
Arm/Group Description	AST-120: 9g /day (3 times a day)	Placebo: 9g /day (3 times a day)
Measure Participants	507	509
Baseline	688.1 (1881.58)	620.5 (1630.87)
Week 12	597.3 (1824.74)	570.0 (1347.75)
Week 24	554.2 (1654.52)	483.7 (536.30)
Week 36	500.6 (568.44)	581.6 (1316.46)
Week 48	530.6 (759.54)	500.2 (940.36)
Week 60	494.2 (534.92)	704.9 (2338.15)
Week 72	545.9 (1268.50)	661.8 (2014.14)
Week 84	497.6 (923.15)	543.1 (1246.14)
Week 96	646.6 (2012.14)	799.6 (2767.12)
Week 108	544.1 (1564.38)	682.2 (1947.45)
Week 120	590.0 (1968.53)	638.4 (1993.90)
Week 132	923.7 (3358.51)	714.2 (2262.71)
Week 144	460.5 (291.19)	472.6 (283.43)
Week 156	476.3 (285.02)	586.3 (811.97)
Week 168	563.9 (528.25)	493.7 (342.53)
Week 180	564.2 (254.57)	653.8 (694.69)
Week 192	489.0 (306.00)	974.0 (898.28)
Early Term/Discontinuation	935.7 (2400.94)	953.5 (2914.40)
Final Visit	626.7 (1464.99)	747.1 (2495.49)

6. Secondary Outcome

Title	25-Hydroxyvitamin D Levels
Description
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)

Outcome Measure Data

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

Arm/Group Title	AST-120	Placebo
Arm/Group Description	AST-120: 9g /day (3 times a day)	Placebo: 9g /day (3 times a day)
Measure Participants	507	509
Baseline	22.08 (10.361)	22.06 (10.400)
Week 12	21.55 (9.988)	22.15 (10.162)
Week 24	21.41 (9.823)	22.13 (9.648)
Week 36	21.70 (10.539)	21.70 (9.926)
Week 48	21.83 (10.963)	22.06 (10.644)
Week 60	21.78 (11.076)	21.56 (10.425)
Week 72	22.23 (10.988)	22.29 (9.617)
Week 84	21.79 (10.759)	22.75 (10.528)
Week 96	22.18 (11.563)	22.53 (10.833)
Week 108	21.85 (11.324)	21.62 (10.679)
Week 120	22.15 (11.189)	22.45 (9.344)
Week 132	22.04 (10.581)	21.83 (10.285)
Week 144	23.29 (11.051)	22.95 (11.046)
Week 156	23.23 (9.857)	23.01 (12.943)
Week 168	25.45 (12.045)	24.44 (11.403)
Week 180	29.58 (12.985)	28.10 (10.929)
Week 192	33.10 (6.651)	31.38 (9.606)
Early Term/Discontinuation	20.57 (9.958)	22.52 (11.803)
Final Visit	25.20 (10.847)	25.69 (9.937)

7. Secondary Outcome

Title	Vitamin E Levels
Description
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)

Outcome Measure Data

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

Arm/Group Title	AST-120	Placebo
Arm/Group Description	AST-120: 9g /day (3 times a day)	Placebo: 9g /day (3 times a day)
Measure Participants	507	509
Baseline	17.49 (7.554)	16.95 (6.923)
Week 12	17.30 (6.880)	16.44 (6.080)
Week 24	17.55 (7.237)	17.08 (6.560)
Week 36	17.42 (6.474)	17.22 (6.445)
Week 48	17.58 (7.040)	17.31 (6.544)
Week 60	17.77 (7.376)	17.70 (6.880)
Week 72	17.50 (6.683)	17.07 (6.119)
Week 84	17.70 (6.779)	17.27 (6.440)
Week 96	17.24 (6.510)	17.28 (6.480)
Week 108	17.60 (6.580)	17.07 (6.126)
Week 120	18.18 (7.293)	17.17 (6.416)
Week 132	18.71 (7.926)	16.52 (5.407)
Week 144	18.02 (6.653)	16.47 (6.805)
Week 156	17.59 (5.937)	17.21 (7.081)
Week 168	16.60 (5.946)	18.00 (8.052)
Week 180	15.52 (4.696)	15.17 (7.808)
Week 192	14.00 (3.568)	16.45 (5.341)
Early Term/Discontinuation	15.72 (5.512)	15.58 (6.200)
Final Visit	17.14 (7.356)	16.03 (5.606)

8. Secondary Outcome

Title	Vitamin K Levels
Description
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)

Outcome Measure Data

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

Arm/Group Title	AST-120	Placebo
Arm/Group Description	AST-120: 9g /day (3 times a day)	Placebo: 9g /day (3 times a day)
Measure Participants	507	509
Baseline	0.711 (0.6276)	0.721 (0.6308)
Week 12	0.752 (0.6601)	0.769 (0.6887)
Week 24	0.705 (0.6006)	0.706 (0.6238)
Week 36	0.739 (0.6726)	0.748 (0.6630)
Week 48	0.763 (0.6630)	0.704 (0.6491)
Week 60	0.761 (0.6868)	0.778 (0.7247)
Week 72	0.823 (0.7291)	0.722 (0.6489)
Week 84	0.780 (0.7174)	0.725 (0.6869)
Week 96	0.809 (0.7156)	0.768 (0.6867)
Week 108	0.802 (0.6797)	0.768 (0.7119)
Week 120	0.768 (0.6708)	0.814 (0.7119)
Week 132	0.824 (0.7655)	0.760 (0.5740)
Week 144	0.882 (0.7630)	0.780 (0.6052)
Week 156	0.754 (0.6129)	0.816 (0.6822)
Week 168	0.858 (0.6494)	1.031 (0.8805)
Week 180	0.850 (0.7162)	0.970 (0.9033)
Early Term/Discontinuation	0.735 (0.7523)	0.686 (0.5772)
Final Visit	0.971 (0.7657)	0.844 (0.6784)

9. Secondary Outcome

Title	Serum Folate Levels
Description
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)

Outcome Measure Data

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

Arm/Group Title	AST-120	Placebo
Arm/Group Description	AST-120: 9g /day (3 times a day)	Placebo: 9g /day (3 times a day)
Measure Participants	507	509
Baseline	21.70 (44.420)	21.78 (47.064)
Week 12	21.47 (46.801)	20.94 (45.093)
Week 24	18.16 (34.095)	19.46 (45.178)
Week 36	20.95 (47.528)	18.54 (41.653)
Week 48	19.30 (44.798)	21.50 (49.944)
Week 60	19.06 (41.799)	19.72 (45.119)
Week 72	16.12 (32.761)	19.96 (43.951)
Week 84	17.00 (30.020)	20.95 (46.184)
Week 96	14.47 (25.918)	18.17 (36.846)
Week 108	13.50 (18.491)	19.22 (39.625)
Week 120	12.52 (16.033)	17.01 (36.733)
Week 132	17.09 (45.645)	18.85 (44.240)
Week 144	18.13 (41.386)	18.09 (39.002)
Week 156	13.08 (13.098)	15.13 (20.162)
Week 168	15.13 (12.776)	16.26 (19.734)
Week 180	33.10 (19.021)	22.23 (25.137)
Early Term/Discontinuation	24.43 (49.342)	17.14 (24.122)
Final Visit	15.52 (26.263)	22.66 (50.498)

Adverse Events

	AST-120		Placebo
Time Frame
Adverse Event Reporting Description	The AE analysis is based on the Safety Population. The Safety Population included all patients who were randomized and received at least 1 dose of study drug. The start number of Participant Flow included all patients who were randomized.

Arm/Group Title	AST-120		Placebo
Arm/Group Description	AST-120: 9g /day (3 times a day)		Placebo: 9g /day (3 times a day)
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	AST-120		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	195/507 (38.5%)		184/509 (36.1%)
Blood and lymphatic system disorders
Anaemia	8/507 (1.6%)		7/509 (1.4%)
Anaemia of chronic disease	1/507 (0.2%)		0/509 (0%)
Iron deficiency anaemia	0/507 (0%)		1/509 (0.2%)
Lymphadenopathy	1/507 (0.2%)		0/509 (0%)
Nephrogenic anaemia	1/507 (0.2%)		0/509 (0%)
Thrombocytopenia	1/507 (0.2%)		0/509 (0%)
Cardiac disorders
Acute coronary syndrome	5/507 (1%)		3/509 (0.6%)
Acute myocardial infarction	7/507 (1.4%)		5/509 (1%)
Angina pectoris	5/507 (1%)		2/509 (0.4%)
Angina unstable	0/507 (0%)		1/509 (0.2%)
Aortic valve incompetence	1/507 (0.2%)		0/509 (0%)
Arteriosclerosis coronary artery	2/507 (0.4%)		0/509 (0%)
Atrial fibrillation	1/507 (0.2%)		2/509 (0.4%)
Atrial flutter	2/507 (0.4%)		0/509 (0%)
Atrioventricular block complete	1/507 (0.2%)		1/509 (0.2%)
Bradycardia	2/507 (0.4%)		1/509 (0.2%)
Bundle branch block left	0/507 (0%)		1/509 (0.2%)
Cardiac failure	3/507 (0.6%)		4/509 (0.8%)
Cardiac failure acute	1/507 (0.2%)		3/509 (0.6%)
Cardiac failure chronic	1/507 (0.2%)		0/509 (0%)
Cardiac failure congestive	11/507 (2.2%)		9/509 (1.8%)
Cardiac valve disease	1/507 (0.2%)		0/509 (0%)
Cardio-respiratory arrest	1/507 (0.2%)		0/509 (0%)
Cardiomyopathy	1/507 (0.2%)		1/509 (0.2%)
Coronary artery disease	3/507 (0.6%)		5/509 (1%)
Coronary artery stenosis	0/507 (0%)		1/509 (0.2%)
Left ventricular dysfunction	0/507 (0%)		1/509 (0.2%)
Myocardial infarction	5/507 (1%)		1/509 (0.2%)
Myocardial ischaemia	1/507 (0.2%)		0/509 (0%)
Pericarditis	1/507 (0.2%)		0/509 (0%)
Right ventricular failure	2/507 (0.4%)		0/509 (0%)
Sick sinus syndrome	0/507 (0%)		1/509 (0.2%)
Supraventricular tachycardia	1/507 (0.2%)		0/509 (0%)
Tachycardia	1/507 (0.2%)		0/509 (0%)
Ventricular tachyarrhythmia	1/507 (0.2%)		0/509 (0%)
Ventricular tachycardia	0/507 (0%)		1/509 (0.2%)
Ear and labyrinth disorders
Vertigo	1/507 (0.2%)		0/509 (0%)
Eye disorders
Blindness	0/507 (0%)		1/509 (0.2%)
Cataract	2/507 (0.4%)		0/509 (0%)
Conjunctival haemorrhage	0/507 (0%)		1/509 (0.2%)
Eye haemorrhage	0/507 (0%)		1/509 (0.2%)
Open angle glaucoma	1/507 (0.2%)		0/509 (0%)
Gastrointestinal disorders
Abdominal pain	1/507 (0.2%)		0/509 (0%)
Abdominal pain upper	0/507 (0%)		1/509 (0.2%)
Constipation	0/507 (0%)		1/509 (0.2%)
Diabetic gastroparesis	0/507 (0%)		1/509 (0.2%)
Diarrhoea	1/507 (0.2%)		1/509 (0.2%)
Duodenal ulcer	1/507 (0.2%)		1/509 (0.2%)
Duodenal ulcer haemorrhage	1/507 (0.2%)		0/509 (0%)
Duodenal ulcer perforation	1/507 (0.2%)		0/509 (0%)
Duodenitis	1/507 (0.2%)		0/509 (0%)
Dyspepsia	1/507 (0.2%)		0/509 (0%)
Food poisoning	0/507 (0%)		1/509 (0.2%)
Gastric haemorrhage	1/507 (0.2%)		0/509 (0%)
Gastric ulcer	0/507 (0%)		2/509 (0.4%)
Gastric ulcer haemorrhage	0/507 (0%)		1/509 (0.2%)
Gastritis	3/507 (0.6%)		4/509 (0.8%)
Gastritis haemorrhagic	1/507 (0.2%)		1/509 (0.2%)
Gastrointestinal haemorrhage	1/507 (0.2%)		3/509 (0.6%)
Gastrooesophageal reflux disease	1/507 (0.2%)		0/509 (0%)
Haemorrhoids	1/507 (0.2%)		0/509 (0%)
Hiatus hernia	1/507 (0.2%)		0/509 (0%)
Ileus	0/507 (0%)		1/509 (0.2%)
Inguinal hernia	0/507 (0%)		1/509 (0.2%)
Intestinal ischaemia	1/507 (0.2%)		0/509 (0%)
Nausea	3/507 (0.6%)		0/509 (0%)
Oesophageal spasm	0/507 (0%)		1/509 (0.2%)
Oesophagitis	0/507 (0%)		1/509 (0.2%)
Pancreatic necrosis	1/507 (0.2%)		0/509 (0%)
Pancreatitis chronic	1/507 (0.2%)		0/509 (0%)
Pancreatitis relapsing	1/507 (0.2%)		0/509 (0%)
Peptic ulcer	1/507 (0.2%)		0/509 (0%)
Peptic ulcer haemorrhage	1/507 (0.2%)		0/509 (0%)
Rectal haemorrhage	1/507 (0.2%)		0/509 (0%)
Small intestinal obstruction	0/507 (0%)		1/509 (0.2%)
Upper gastrointestinal haemorrhage	1/507 (0.2%)		0/509 (0%)
Vomiting	3/507 (0.6%)		1/509 (0.2%)
General disorders
Asthenia	1/507 (0.2%)		0/509 (0%)
Catheter site haemorrhage	1/507 (0.2%)		0/509 (0%)
Catheter site related reaction	0/507 (0%)		1/509 (0.2%)
Chest pain	1/507 (0.2%)		1/509 (0.2%)
Death	0/507 (0%)		1/509 (0.2%)
Generalised oedema	0/507 (0%)		1/509 (0.2%)
Hernia	1/507 (0.2%)		0/509 (0%)
Impaired healing	0/507 (0%)		1/509 (0.2%)
Implant site haematoma	0/507 (0%)		1/509 (0.2%)
Lipogranuloma	1/507 (0.2%)		0/509 (0%)
Non-cardiac chest pain	0/507 (0%)		2/509 (0.4%)
Oedema peripheral	2/507 (0.4%)		0/509 (0%)
Pyrexia	1/507 (0.2%)		1/509 (0.2%)
Hepatobiliary disorders
Cholecystitis acute	0/507 (0%)		1/509 (0.2%)
Cholelithiasis	0/507 (0%)		1/509 (0.2%)
Hepatorenal failure	1/507 (0.2%)		0/509 (0%)
Immune system disorders
Anaphylactic shock	1/507 (0.2%)		0/509 (0%)
Infections and infestations
Abscess limb	1/507 (0.2%)		0/509 (0%)
Acute sinusitis	0/507 (0%)		1/509 (0.2%)
Appendicitis	0/507 (0%)		2/509 (0.4%)
Appendicitis perforated	0/507 (0%)		1/509 (0.2%)
Bacterial sepsis	0/507 (0%)		1/509 (0.2%)
Bronchitis	1/507 (0.2%)		2/509 (0.4%)
Bronchopneumonia	0/507 (0%)		1/509 (0.2%)
Catheter site cellulitis	0/507 (0%)		1/509 (0.2%)
Cellulitis	4/507 (0.8%)		3/509 (0.6%)
Cholecystitis infective	1/507 (0.2%)		0/509 (0%)
Chronic sinusitis	0/507 (0%)		1/509 (0.2%)
Device related infection	1/507 (0.2%)		0/509 (0%)
Epiglottitis	1/507 (0.2%)		0/509 (0%)
Erysipelas	1/507 (0.2%)		0/509 (0%)
Furuncle	1/507 (0.2%)		0/509 (0%)
Gangrene	0/507 (0%)		1/509 (0.2%)
Gastritis viral	1/507 (0.2%)		0/509 (0%)
Gastroenteritis	4/507 (0.8%)		4/509 (0.8%)
Gastroenteritis viral	1/507 (0.2%)		0/509 (0%)
H1N1 influenza	1/507 (0.2%)		0/509 (0%)
Herpes zoster	1/507 (0.2%)		0/509 (0%)
Influenza	2/507 (0.4%)		0/509 (0%)
Klebsiella bacteraemia	0/507 (0%)		1/509 (0.2%)
Lobar pneumonia	1/507 (0.2%)		2/509 (0.4%)
Localised infection	0/507 (0%)		1/509 (0.2%)
Lung abscess	1/507 (0.2%)		0/509 (0%)
Lyme disease	1/507 (0.2%)		0/509 (0%)
Osteomyelitis	1/507 (0.2%)		2/509 (0.4%)
Osteomyelitis chronic	0/507 (0%)		1/509 (0.2%)
Pneumonia	13/507 (2.6%)		13/509 (2.6%)
Pneumonia bacterial	1/507 (0.2%)		0/509 (0%)
Pneumonia herpes viral	1/507 (0.2%)		0/509 (0%)
Pneumonia legionella	1/507 (0.2%)		0/509 (0%)
Pyelonephritis	1/507 (0.2%)		2/509 (0.4%)
Pyelonephritis acute	0/507 (0%)		2/509 (0.4%)
Pyelonephritis chronic	1/507 (0.2%)		3/509 (0.6%)
Respiratory tract infection	1/507 (0.2%)		0/509 (0%)
Sepsis	1/507 (0.2%)		1/509 (0.2%)
Sepsis syndrome	1/507 (0.2%)		0/509 (0%)
Streptococcal sepsis	0/507 (0%)		1/509 (0.2%)
Tuberculosis	1/507 (0.2%)		0/509 (0%)
Upper respiratory tract infection	0/507 (0%)		1/509 (0.2%)
Urinary tract infection	1/507 (0.2%)		4/509 (0.8%)
Urosepsis	0/507 (0%)		1/509 (0.2%)
Viral infection	0/507 (0%)		2/509 (0.4%)
Injury, poisoning and procedural complications
Ankle fracture	0/507 (0%)		1/509 (0.2%)
Arteriovenous fistula thrombosis	0/507 (0%)		1/509 (0.2%)
Fall	1/507 (0.2%)		0/509 (0%)
Fibula fracture	0/507 (0%)		1/509 (0.2%)
Heat stroke	0/507 (0%)		1/509 (0.2%)
Ligament sprain	0/507 (0%)		1/509 (0.2%)
Lower limb fracture	1/507 (0.2%)		1/509 (0.2%)
Perirenal haematoma	0/507 (0%)		1/509 (0.2%)
Rib fracture	1/507 (0.2%)		1/509 (0.2%)
Shunt malfunction	0/507 (0%)		1/509 (0.2%)
Subdural haematoma	0/507 (0%)		1/509 (0.2%)
Investigations
Blood creatinine increased	3/507 (0.6%)		0/509 (0%)
Blood glucose increased	1/507 (0.2%)		0/509 (0%)
Metabolism and nutrition disorders
Dehydration	2/507 (0.4%)		1/509 (0.2%)
Diabetes mellitus	2/507 (0.4%)		2/509 (0.4%)
Diabetes mellitus inadequate control	2/507 (0.4%)		1/509 (0.2%)
Diabetic foot	2/507 (0.4%)		1/509 (0.2%)
Diabetic ketoacidosis	0/507 (0%)		1/509 (0.2%)
Fluid overload	2/507 (0.4%)		2/509 (0.4%)
Gout	1/507 (0.2%)		0/509 (0%)
Hyperglycaemia	0/507 (0%)		2/509 (0.4%)
Hyperkalaemia	2/507 (0.4%)		5/509 (1%)
Hypoglycaemia	5/507 (1%)		4/509 (0.8%)
Hypoglycaemic seizure	1/507 (0.2%)		0/509 (0%)
Hypokalaemia	0/507 (0%)		1/509 (0.2%)
Hyponatraemia	1/507 (0.2%)		0/509 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/507 (0.2%)		2/509 (0.4%)
Gouty arthritis	0/507 (0%)		2/509 (0.4%)
Lumbar spinal stenosis	1/507 (0.2%)		1/509 (0.2%)
Musculoskeletal chest pain	2/507 (0.4%)		0/509 (0%)
Osteoarthritis	0/507 (0%)		1/509 (0.2%)
Osteonecrosis	1/507 (0.2%)		0/509 (0%)
Pseudarthrosis	0/507 (0%)		1/509 (0.2%)
Spinal osteoarthritis	0/507 (0%)		2/509 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign duodenal neoplasm	0/507 (0%)		1/509 (0.2%)
Bladder cancer	1/507 (0.2%)		0/509 (0%)
Breast cancer	0/507 (0%)		1/509 (0.2%)
Carcinoid tumour pulmonary	1/507 (0.2%)		0/509 (0%)
Cervix carcinoma stage 0	0/507 (0%)		1/509 (0.2%)
Colon cancer	1/507 (0.2%)		1/509 (0.2%)
Hypopharyngeal cancer	1/507 (0.2%)		0/509 (0%)
Laryngeal cancer	2/507 (0.4%)		0/509 (0%)
Lung adenocarcinoma	1/507 (0.2%)		0/509 (0%)
Lung squamous cell carcinoma stage unspecified	1/507 (0.2%)		0/509 (0%)
Metastatic squamous cell carcinoma	1/507 (0.2%)		0/509 (0%)
Multiple myeloma	0/507 (0%)		1/509 (0.2%)
Prostate cancer	0/507 (0%)		2/509 (0.4%)
Sarcoma	0/507 (0%)		1/509 (0.2%)
Testicular seminoma (pure)	0/507 (0%)		1/509 (0.2%)
Nervous system disorders
Altered state of consciousness	1/507 (0.2%)		0/509 (0%)
Carotid artery stenosis	1/507 (0.2%)		0/509 (0%)
Cerebellar haemorrhage	1/507 (0.2%)		0/509 (0%)
Cerebrovascular accident	4/507 (0.8%)		3/509 (0.6%)
Complex partial seizures	0/507 (0%)		1/509 (0.2%)
Convulsion	0/507 (0%)		1/509 (0.2%)
Dementia	1/507 (0.2%)		0/509 (0%)
Haemorrhage intracranial	0/507 (0%)		1/509 (0.2%)
Haemorrhagic stroke	2/507 (0.4%)		1/509 (0.2%)
Headache	0/507 (0%)		1/509 (0.2%)
Hypoglycaemic coma	0/507 (0%)		1/509 (0.2%)
Ischaemic stroke	1/507 (0.2%)		3/509 (0.6%)
Lumbar radiculopathy	0/507 (0%)		1/509 (0.2%)
Metabolic encephalopathy	1/507 (0.2%)		0/509 (0%)
Syncope	1/507 (0.2%)		3/509 (0.6%)
Transient ischaemic attack	1/507 (0.2%)		1/509 (0.2%)
Uraemic encephalopathy	0/507 (0%)		1/509 (0.2%)
Psychiatric disorders
Delirium	0/507 (0%)		1/509 (0.2%)
Mental status changes	0/507 (0%)		2/509 (0.4%)
Renal and urinary disorders
Azotaemia	4/507 (0.8%)		1/509 (0.2%)
Diabetic nephropathy	1/507 (0.2%)		1/509 (0.2%)
Glomerulonephritis acute	1/507 (0.2%)		0/509 (0%)
Glomerulonephritis chronic	1/507 (0.2%)		1/509 (0.2%)
Nephropathy toxic	1/507 (0.2%)		0/509 (0%)
Renal failure	4/507 (0.8%)		2/509 (0.4%)
Renal failure acute	9/507 (1.8%)		22/509 (4.3%)
Renal failure chronic	48/507 (9.5%)		45/509 (8.8%)
Renal impairment	3/507 (0.6%)		3/509 (0.6%)
Ureteric stenosis	0/507 (0%)		1/509 (0.2%)
Urinary retention	0/507 (0%)		2/509 (0.4%)
Reproductive system and breast disorders
Acquired hydrocele	1/507 (0.2%)		0/509 (0%)
Acquired phimosis	1/507 (0.2%)		0/509 (0%)
Benign prostatic hyperplasia	1/507 (0.2%)		0/509 (0%)
Metrorrhagia	0/507 (0%)		2/509 (0.4%)
Polymenorrhoea	0/507 (0%)		1/509 (0.2%)
Scrotal oedema	0/507 (0%)		1/509 (0.2%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	0/507 (0%)		1/509 (0.2%)
Acute respiratory failure	1/507 (0.2%)		2/509 (0.4%)
Aspiration	2/507 (0.4%)		0/509 (0%)
Asthma	1/507 (0.2%)		1/509 (0.2%)
Atelectasis	1/507 (0.2%)		0/509 (0%)
Chronic obstructive pulmonary disease	2/507 (0.4%)		4/509 (0.8%)
Dyspnoea	1/507 (0.2%)		6/509 (1.2%)
Haemoptysis	1/507 (0.2%)		0/509 (0%)
Hydrothorax	1/507 (0.2%)		1/509 (0.2%)
Interstitial lung disease	1/507 (0.2%)		0/509 (0%)
Pleural effusion	0/507 (0%)		1/509 (0.2%)
Pneumonia aspiration	1/507 (0.2%)		0/509 (0%)
Pulmonary embolism	0/507 (0%)		3/509 (0.6%)
Pulmonary hypertension	1/507 (0.2%)		1/509 (0.2%)
Pulmonary oedema	2/507 (0.4%)		2/509 (0.4%)
Respiratory distress	0/507 (0%)		2/509 (0.4%)
Respiratory failure	1/507 (0.2%)		2/509 (0.4%)
Skin and subcutaneous tissue disorders
Drug eruption	1/507 (0.2%)		0/509 (0%)
Neuropathic ulcer	1/507 (0.2%)		0/509 (0%)
Skin ulcer	0/507 (0%)		1/509 (0.2%)
Surgical and medical procedures
Abortion induced	0/507 (0%)		1/509 (0.2%)
Arteriovenous fistula operation	16/507 (3.2%)		8/509 (1.6%)
Arteriovenous shunt operation	1/507 (0.2%)		0/509 (0%)
Cardiac pacemaker insertion	0/507 (0%)		1/509 (0.2%)
Catheter placement	1/507 (0.2%)		0/509 (0%)
Central venous catheterisation	2/507 (0.4%)		0/509 (0%)
Dialysis device insertion	1/507 (0.2%)		0/509 (0%)
Inguinal hernia repair	1/507 (0.2%)		0/509 (0%)
Insertion of ambulatory peritoneal catheter	2/507 (0.4%)		6/509 (1.2%)
Leg amputation	0/507 (0%)		1/509 (0.2%)
Prosthesis implantation	0/507 (0%)		1/509 (0.2%)
Vascular disorders
Aortic stenosis	1/507 (0.2%)		0/509 (0%)
Arterial stenosis	1/507 (0.2%)		0/509 (0%)
Arterial thrombosis limb	1/507 (0.2%)		0/509 (0%)
Circulatory collapse	0/507 (0%)		1/509 (0.2%)
Deep vein thrombosis	0/507 (0%)		1/509 (0.2%)
Extremity necrosis	0/507 (0%)		1/509 (0.2%)
Femoral arterial stenosis	0/507 (0%)		1/509 (0.2%)
Hypertension	3/507 (0.6%)		1/509 (0.2%)
Hypertensive crisis	5/507 (1%)		2/509 (0.4%)
Hypertensive emergency	0/507 (0%)		1/509 (0.2%)
Hypotension	1/507 (0.2%)		0/509 (0%)
Orthostatic hypotension	0/507 (0%)		3/509 (0.6%)
Peripheral ischaemia	1/507 (0.2%)		0/509 (0%)
Thrombophlebitis	0/507 (0%)		1/509 (0.2%)
Other (Not Including Serious) Adverse Events
	AST-120		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	376/507 (74.2%)		382/509 (75%)
Blood and lymphatic system disorders
Anaemia	58/507 (11.4%)		81/509 (15.9%)
Iron deficiency anaemia	6/507 (1.2%)		5/509 (1%)
Cardiac disorders
Angina pectoris	9/507 (1.8%)		2/509 (0.4%)
Bradycardia	4/507 (0.8%)		8/509 (1.6%)
Endocrine disorders
Hyperparathyroidism	9/507 (1.8%)		10/509 (2%)
Hyperparathyroidism secondary	11/507 (2.2%)		17/509 (3.3%)
Eye disorders
Cataract	14/507 (2.8%)		9/509 (1.8%)
Gastrointestinal disorders
Abdominal distension	13/507 (2.6%)		10/509 (2%)
Abdominal pain	11/507 (2.2%)		15/509 (2.9%)
Abdominal pain upper	13/507 (2.6%)		6/509 (1.2%)
Constipation	42/507 (8.3%)		37/509 (7.3%)
Diarrhoea	29/507 (5.7%)		37/509 (7.3%)
Dyspepsia	12/507 (2.4%)		14/509 (2.8%)
Faeces discoloured	1/507 (0.2%)		6/509 (1.2%)
Flatulence	7/507 (1.4%)		12/509 (2.4%)
Gastritis	6/507 (1.2%)		14/509 (2.8%)
Gastrooesophageal reflux disease	2/507 (0.4%)		8/509 (1.6%)
Nausea	47/507 (9.3%)		42/509 (8.3%)
Vomiting	23/507 (4.5%)		21/509 (4.1%)
General disorders
Asthenia	17/507 (3.4%)		11/509 (2.2%)
Fatigue	16/507 (3.2%)		24/509 (4.7%)
Oedema	13/507 (2.6%)		9/509 (1.8%)
Oedema peripheral	57/507 (11.2%)		50/509 (9.8%)
Pyrexia	6/507 (1.2%)		8/509 (1.6%)
Immune system disorders
Seasonal allergy	2/507 (0.4%)		6/509 (1.2%)
Infections and infestations
Bronchitis	23/507 (4.5%)		16/509 (3.1%)
Cellulitis	7/507 (1.4%)		2/509 (0.4%)
Erysipelas	6/507 (1.2%)		1/509 (0.2%)
Gastroenteritis	13/507 (2.6%)		9/509 (1.8%)
Herpes zoster	3/507 (0.6%)		6/509 (1.2%)
Influenza	20/507 (3.9%)		21/509 (4.1%)
Nasopharyngitis	18/507 (3.6%)		17/509 (3.3%)
Pharyngitis	8/507 (1.6%)		9/509 (1.8%)
Pneumonia	4/507 (0.8%)		9/509 (1.8%)
Pyelonephritis chronic	3/507 (0.6%)		8/509 (1.6%)
Respiratory tract infection	16/507 (3.2%)		12/509 (2.4%)
Rhinitis	5/507 (1%)		6/509 (1.2%)
Sinusitis	7/507 (1.4%)		12/509 (2.4%)
Upper respiratory tract infection	24/507 (4.7%)		31/509 (6.1%)
Urinary tract infection	37/507 (7.3%)		19/509 (3.7%)
Injury, poisoning and procedural complications
Ligament sprain	6/507 (1.2%)		1/509 (0.2%)
Investigations
Blood creatine phosphokinase increased	10/507 (2%)		8/509 (1.6%)
Vitamin D decreased	6/507 (1.2%)		6/509 (1.2%)
Metabolism and nutrition disorders
Acidosis	4/507 (0.8%)		7/509 (1.4%)
Decreased appetite	11/507 (2.2%)		12/509 (2.4%)
Dehydration	4/507 (0.8%)		7/509 (1.4%)
Dyslipidaemia	9/507 (1.8%)		9/509 (1.8%)
Fluid overload	7/507 (1.4%)		1/509 (0.2%)
Gout	24/507 (4.7%)		21/509 (4.1%)
Hypercalcaemia	8/507 (1.6%)		8/509 (1.6%)
Hypercholesterolaemia	4/507 (0.8%)		8/509 (1.6%)
Hyperglycaemia	13/507 (2.6%)		11/509 (2.2%)
Hyperkalaemia	35/507 (6.9%)		36/509 (7.1%)
Hyperlipidaemia	10/507 (2%)		3/509 (0.6%)
Hyperphosphataemia	21/507 (4.1%)		26/509 (5.1%)
Hyperuricaemia	4/507 (0.8%)		8/509 (1.6%)
Hypocalcaemia	6/507 (1.2%)		5/509 (1%)
Hypoglycaemia	9/507 (1.8%)		14/509 (2.8%)
Metabolic acidosis	18/507 (3.6%)		27/509 (5.3%)
Vitamin D deficiency	11/507 (2.2%)		12/509 (2.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	22/507 (4.3%)		23/509 (4.5%)
Back pain	18/507 (3.6%)		22/509 (4.3%)
Muscle spasms	13/507 (2.6%)		18/509 (3.5%)
Musculoskeletal pain	6/507 (1.2%)		9/509 (1.8%)
Myalgia	3/507 (0.6%)		7/509 (1.4%)
Osteoarthritis	10/507 (2%)		8/509 (1.6%)
Pain in extremity	16/507 (3.2%)		12/509 (2.4%)
Nervous system disorders
Dizziness	8/507 (1.6%)		11/509 (2.2%)
Headache	21/507 (4.1%)		12/509 (2.4%)
Psychiatric disorders
Depression	6/507 (1.2%)		5/509 (1%)
Insomnia	8/507 (1.6%)		10/509 (2%)
Renal and urinary disorders
Renal failure acute	5/507 (1%)		8/509 (1.6%)
Renal failure chronic	42/507 (8.3%)		55/509 (10.8%)
Renal impairment	10/507 (2%)		6/509 (1.2%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	2/507 (0.4%)		8/509 (1.6%)
Respiratory, thoracic and mediastinal disorders
Cough	19/507 (3.7%)		15/509 (2.9%)
Dyspnoea	19/507 (3.7%)		12/509 (2.4%)
Epistaxis	7/507 (1.4%)		7/509 (1.4%)
Skin and subcutaneous tissue disorders
Pruritus	13/507 (2.6%)		21/509 (4.1%)
Rash	7/507 (1.4%)		8/509 (1.6%)
Surgical and medical procedures
Arteriovenous fistula operation	19/507 (3.7%)		22/509 (4.3%)
Vascular disorders
Hypertension	55/507 (10.8%)		47/509 (9.2%)
Hypotension	9/507 (1.8%)		14/509 (2.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results Point of Contact

Name/Title	Clinical Trials, Information Desk
Organization	Mitsubishi Tanabe Pharma Corporation
Phone
Email	cti-inq-ml@ml.mt-pharma.co.jp

Responsible Party:

Mitsubishi Tanabe Pharma Corporation

ClinicalTrials.gov Identifier:

NCT00500682

Other Study ID Numbers:

KRM-306

First Posted:

Jul 13, 2007

Last Update Posted:

Jun 7, 2022

Last Verified:

May 1, 2022

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

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact