Status:
COMPLETED
Kremezin Study Against Renal Disease Progression in Korea
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
HK inno.N Corporation
Kureha Corporation
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
578 Patients enrolled
Trial Details
Trial ID
NCT00860431
Start Date
March 1 2009
End Date
September 1 2013
Last Update
March 19 2014
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744