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

This study has been completed.
Sponsor:
Collaborators:
CJ HealthCare Corporation
Kureha Corporation
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00860431
First received: March 9, 2009
Last updated: March 17, 2014
Last verified: March 2014
  Purpose
  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
Endpoint Classification: Safety/Efficacy Study
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) ] [ Designated as safety issue: Yes ]

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) ] [ Designated as safety issue: Yes ]

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860431

Locations
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
Investigators
Principal Investigator: Yon Su Kim, M.D.PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Yon Su Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00860431     History of Changes
Other Study ID Numbers: 06-2008-355-0
Study First Received: March 9, 2009
Last Updated: March 17, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Disease Progression
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Disease Attributes
Pathologic Processes
Renal Insufficiency

ClinicalTrials.gov processed this record on July 23, 2014