Study General Details Inclusion Criteria Exclusion Criteria Intervention Outcomes
Akizawa 2009
Country: Japan Study design: randomized controlled trial Number: treatment group (231), control group (229) Duration: 56 weeks Chronic kidney disease stage of treatment group subjects: 3 or lower (21%), 4 (47%), 5 (32%) Chronic kidney disease stage of control group subjects: 3 or lower (20%), 4 (53%), 5 (27%) Outpatient 20 years or older at the time of consent to participate in the study Serum creatinine level of 5.0 mg/dL or less at the time of case registration Inverse serum creatinine (calculated by using measurements at ≥ 4 times during an observation period that occurred within 48 weeks of case registration) that is decreasing on average, determined by using linear regression analysis Blood pressure that is well controlled before the initial serum creatinine measurement during the observation period Treatment with an angiotensin-converting enzyme inhibitor and/or angiotensinogen II receptor blocker before the initial serum creatinine measurement during the observation period Receipt of low-protein diet therapy (protein < 0.8 g/kg/d) before the initial serum creatinine measurement during the observation period No change in type or dose of medication for kidney disease during the 4 weeks before case registration Participant has been informed about the purpose, description, expected adverse effects, and risks of this study according to the consent form and has voluntarily signed the informed consent form Presence of obstructive disorder of the gastrointestinal tract (constipation, ileus, and so on) Treatment with AST-120 within the period from the initial serum creatinine measurement before case registration to the time of study commencement Presence of rapidly progressive glomerular nephritis, hydronephrosis, obstructive uropathy, drug-induced nephropathy, or transplanted kidney Presence of such complications as severe hepatopathy, liver cirrhosis, severe infection, class III or higher New York Heart Association congestive heart failure, severe arrhythmia, or unstable angina Occurrence of cardiac infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months Presence of severe nephrotic syndrome (serum albumin < 2 g/dL) Pregnancy or planning to become pregnant during the study period Alcohol abuse Body weight less than 80% or more than 160% of the standard weight ([height (m)]2 x 22) Significant difficulty with control of blood glucose levels within 3 months of case registration (hemoglobin A1c > 8.0% on 1 occasion) Presence of progressive malignant tumor Unavailable for study visits at least once per 2 months to provide urine samples Presence of other reasons that made participation in the study inappropriate, as determined by an investigator Treatment group: AST-120 6 g/d (3 divided doses) + conventional treatment Control group: conventional treatment Conventional treatment: low protein diet (protein < 0.8 g/kg/d) + angiotensin-converting enzyme inhibitor or angiotensinogen II receptor blocker Incidence of end-stage renal disease Mortality rate Doubling or serum creatinine Adverse events
Cha 2016
Country: South Korea Study design: randomized controlled trial Number: treatment group (289), control group (290) Duration: 36 months Chronic kidney disease stage of control group subjects: 3 (29.3%), 4 (70.7%) Chronic kidney disease stage of treatment group subjects: 3 (26.5%), 4 (73.5%) Provided informed consent Aged ≥18 years Followed over 6 months by nephrologists Chronic kidney disease stage 3 or 4 Expected estimated glomerular filtration rate decline of ≥2.5 ml/min per 1.73 m2 over 6 months or ≥5 ml/min per 1.73 m2 over 12 months Had controlled blood pressure No significant changes in the medical treatment for chronic kidney disease Taken ketosteril or AST-120 within the last 2 months Gastrointestinal disease, such as an active ulcer or inflammatory bowel disease Obstructive uropathy or other reversible kidney diseases Autosomal dominant polycystic kidney disease Proteinuria ≥10 g/d Received a kidney transplantation Moderate to severe heart failure, uncontrolled arrhythmia, or unstable angina Active infections or uncontrolled inflammatory diseases Liver cirrhosis (Child-Turcotte-Pugh class B or C) Progressive malignancy Cerebral infarction or hemorrhage within the last 6 months Uncontrolled blood sugar level (hemoglobin A1c ≥10.0%) Severe anemia (hemoglobin ≤7.0 g/dl) Life expectancy ≤12 months Pregnant, lactating, planning to be pregnant during study period Determined by the investigators to be inappropriate participants Treatment group: AST-120 6.0 g/day (3 divided doses) + routine treatment Control group: routine treatment Routine treatment: standard care including angiotensin-converting enzyme inhibitor or angiotensinogen II receptor blocker and lipid modifiers, low-salt and low-protein diet Doubling of serum creatinine 50% reduction in glomerular filtration rate End-stage renal disease requiring renal replacement therapy Urinary protein excretion All-cause mortality All-cause hospitalization Quality-of-life assessment
Konishi 2008
Country: Japan Study design: randomized controlled trial Number: treatment group (6), control group (10) Mean duration of follow up: 37 months (control group), 34 months (treatment group) Persistent positive test for urinary protein or > 300 mg/g creatinine of albumin in a spot urine Having type 2 diabetes mellitus Serum creatinine < 1.5 mg/dL 24-h urinary protein excretion > 0.5 g/day No history of cardiovascular diseases Those not satisfying inclusion criteria Treatment group: AST-120 6.0 g/day + conventional treatment Control group: conventional treatment Conventional treatment: blood pressure, lipid, glycemic control Incidence of end-stage renal disease (hemodialysis initiation) Incidence of serum creatinine exceeding 2 mg/dL
Schulman 2015 (EPPIC-1)
Multi-center Study design: randomized controlled trial Number: treatment group (510), control group (510) Median duration: 102.1 weeks (treatment group), 103.3 weeks (control group) Chronic kidney disease stage of subjects in treatment group: 3a (1%), 3b (18.8%), 4 (62%), 5 (18.2%) Chronic kidney disease stage of subjects in control group: 3a (0.2%), 3b (15.3%), 4 (69.3%), 5 (15.1%) Age ≥18 years Moderate to severe chronic kidney disease Proteinuria or progressive decline of renal function Expected not to require renal replacement therapy for 6 months after trial Stable blood pressure in the past 3 months Uncontrolled hypertension Obstructive or reversible kidney disease Nephrotic syndrome (urine protein/urine creatinine 6.0) Adult polycystic kidney disease Uncontrolled arrhythmia or severe cardiovascular disease Immunosuppressive therapy within 3 months Accelerated or malignant hypertension within 6 months History of any of the following: kidney transplantation, malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, and severe gastrointestinal dysmotility not attributable to the use of a phosphate binder Treatment group: AST-120 9.0 g/day (ten 300-mg capsules thrice daily with meals) + routine treatment Control group: placebo (ten 300-mg capsules thrice daily with meals) + routine treatment Routine treatment: not specified Incidence of death Incidence of end-stage renal disease Incidence of doubling of serum creatinine
Schulman 2015 (EPPIC-2)
Multi-center Study design: randomized controlled trial Number: treatment group (508), control group (507) Median duration: 96.3 weeks (treatment group), 91.6 weeks (control group) Chronic kidney disease stage of subjects in treatment group: 3a (0.6%), 3b (16.6%), 4 (66.2%), 5 (16.6%) Chronic kidney disease stage of subjects in control group: 3a (0.4%), 3b (11.7%), 4 (69.2%), 5 (18.7%) Age ≥18 years Moderate to severe chronic kidney disease Proteinuria or progressive decline of renal function Expected not to require renal replacement therapy for 6 months after trial Stable blood pressure in the past 3 months Uncontrolled hypertension Obstructive or reversible kidney disease Nephrotic syndrome (urine protein/urine creatinine 6.0) Adult polycystic kidney disease Uncontrolled arrhythmia or severe cardiovascular disease Immunosuppressive therapy within 3 months Accelerated or malignant hypertension within 6 months History of any of the following: kidney transplantation, malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, and severe gastrointestinal dysmotility not attributable to the use of a phosphate binder Treatment group: AST-120 9.0 g/day (ten 300-mg capsules thrice daily with meals) + routine treatment Control group: placebo (ten 300-mg capsules thrice daily with meals) + routine treatment Routine treatment: not specified Incidence of death Incidence of end-stage renal disease Incidence of doubling of serum creatinine Quality-of-life assessments
Yorioka 2008
Country: Japan Study design: randomized controlled trial Number: treatment group (15), control group (13) Adult patients 20-80 years old Chronic kidney disease stage 3-4 Etiology of chronic kidney disease: chronic glomerulonephritis, diabetic nephropathy, nephrosclerosis Age <20 or >80 years Other underlying kidney diseases Treatment group: AST-120 6.0 g/day + routine treatment Control group: routine treatment Routine treatment: low protein diet + renin-angiotensin-aldosterone system blocker therapy Incidence of end-stage renal disease Change in glomerular filtration rate Change on slope of glomerular filtration rate curve