Kremezin Study Against Renal Disease Progression in Korea

Study Overview
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Brief Summary
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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; To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to GFR and proteinuria; To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to health related quality of life; To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; To evaluate the all-cause mortality and hospitalization apart from those planned for operation and intervention)

Official Title
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K-STAR (Kremezin STudy Against Renal Disease Progression in Korea) Randomized, Open-label, Controlled Study

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: AST-120


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Standard-of-care (conservative treatment) | |
| Experimental: 2<br>AST-120 6g/day (3 times a day) | Drug: AST-120<br>* 6g/day (3 times a day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) |