Phase 3
N=1,020
A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT00500682 ↗Enrolled (actual)
1,020
Serious AEs
37.3%
Results posted
Mar 2015
Primary outcome: Primary: Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported. — 178; 177 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); AST-120 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of Dialysis Initiation, Kidney Transplantation, and Serum Creatinine Doubling. Number of Participants Meeting the Criteria Are Reported. |
178; 177 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events |
436; 448; 195; 184 | — |
| SECONDARY Number of Participants Who Developed a Component of a Quadruple Composite Endpoint (Initiation of Dialysis, Kidney Transplant, Doubling of sCr, or Death) |
213; 201 | — |
| SECONDARY Vitamin A Levels |
1145.3; 1164.2; 1142.4; 1177.9; 1151.5; 1193.6 | — |
| SECONDARY Vitamin B12 Levels |
688.1; 620.5; 597.3; 570.0; 554.2; 483.7 | — |
| SECONDARY 25-Hydroxyvitamin D Levels |
22.08; 22.06; 21.55; 22.15; 21.41; 22.13 | — |
| SECONDARY Vitamin E Levels |
17.49; 16.95; 17.30; 16.44; 17.55; 17.08 | — |
| SECONDARY Vitamin K Levels |
0.711; 0.721; 0.752; 0.769; 0.705; 0.706 | — |
| SECONDARY Serum Folate Levels |
21.70; 21.78; 21.47; 20.94; 18.16; 19.46 | — |
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.
Eligibility Criteria
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 = 1.5 mg/dL (>= 133 µmol/L) and = 0.5 on a spot void at Screening
- Blood pressure 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
Data sourced from ClinicalTrials.gov (NCT00500682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.