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Kremezin Study Against Renal Disease Progression in Korea (K-STAR)

This study has been completed.
CJ HealthCare Corporation
Kureha Corporation
Information provided by:
Seoul National University Hospital Identifier:
First received: March 9, 2009
Last updated: March 17, 2014
Last verified: March 2014
  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)

Condition Intervention Phase
Chronic Kidney Disease
Drug: AST-120
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: K-STAR (Kremezin STudy Against Renal Disease Progression in Korea) Randomized, Open-label, Controlled Study

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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) [ Time Frame: approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up) ]

Secondary Outcome Measures:
  • change of estimated GFR and urine protein excretion, Assessment of health related quality of life, all-cause mortality [ Time Frame: approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up) ]

Estimated Enrollment: 578
Study Start Date: March 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Standard-of-care (conservative treatment)
Experimental: 2
AST-120 6g/day (3 times a day)
Drug: AST-120
6g/day (3 times a day)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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)
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Please refer to this study by its identifier: NCT00860431

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
CJ HealthCare Corporation
Kureha Corporation
Principal Investigator: Yon Su Kim, M.D.PhD Seoul National University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yon Su Kim, Seoul National University Hospital Identifier: NCT00860431     History of Changes
Other Study ID Numbers: 06-2008-355-0
Study First Received: March 9, 2009
Last Updated: March 17, 2014

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Disease Progression
Renal Insufficiency
Urologic Diseases
Disease Attributes
Pathologic Processes processed this record on May 25, 2017