A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease Including Assessment of Quality of Life (EPPIC-2)
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Placebo; AST-120
Intervention description: 9g /day (3 times a day); 9g /day (3 times a day)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1015.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney Diseases

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.
    

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 <= 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