Chronic Kidney Disease
Conditions
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 III-IV), on time to first occurrence of any event of the triple composite outcome of initiation of renal replacement therapy, decline of eGFR 50% or more or doubling of serum creatinine (sCr) when compared with standard-of-care group; 2. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to GFR and proteinuria; 3. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to health related quality of life; 4. To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; 5. To evaluate the all-cause mortality and hospitalization apart from those planned for operation and intervention)
Interventions
DRUGAST-120
6g/day (3 times a day)
Sponsors
HK inno.N Corporation
Kureha Corporation
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent * Age 18 years or older * CKD stage 3,4 (estimated GFR by Cockcroft-Gault equation 15-59 mL/min/1.73m\^2) * Followed up by responsible nephrologists more than 6 months * eGFR checked 2 times or more during screening period * eGFR declined or expected to decline \>= 5mL/min/year or \>=2.5mL/min/6 months * Blood pressure \<= 160/100 mmHg * Blood pressure checked 3 times or more during screening period * No significant change of medication for CKD
Exclusion criteria
* Patients who took medicine AST-120 or ketosteril within 2 months * Received any investigational agent or participated in a clinical study within the previous 2 months * History of gastrointestinal disease (active gastric ulcer, inflammatory bowel disease, hiatal hernia, or severe GI dysmotility) * obstructive urologic disease and other reversible kidney diseases * chronic kidney disease due to autosomal dominant polycystic kidney disease, ADPKD * severe nephrotic syndrome, 10g or more/day(or random urine pCR \>= 10.0) * History of previous kidney transplant * Heart failure (NYHA III-IV), uncontrolled arrhythmia, unstable angina * Liver cirrhosis (Child-Pugh B,C) * active infection, uncontrolled inflammatory disease * progressive malignant disease * cerebral infarction and intracranial hemorrhage within 6 months,except transient ischemic attack (TIA) * uncontrolled blood sugar (HbA1c \>10%) * severe anemia, Hb \<7g/dL * Life expectancy less than 12 months at the point of randomization * Pregnant and willing to bear child during study * patients, inappropriate to study (researchers decided)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The development of a component of a triple composite endpoint (doubling of serum Cr, decline of estimated GFR 50% or more by C-G equation, initiation of renal replacement therapy) | approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up) |
Secondary
| Measure | Time frame |
|---|---|
| change of estimated GFR and urine protein excretion, Assessment of health related quality of life, all-cause mortality | approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up) |
Countries
South Korea
Outcome results
None listed