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Completed

NCT Number: NCT00860431

Kremezin Study Against Renal Disease Progression in Korea

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)

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AST-120

Drug

6g/day (3 times a day)

Primary outcomes

  1. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • HK inno.N Corporation
  • Kureha Corporation

Registry information

Official study title

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

Acronym: K-STAR

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2009
Registry last updated
Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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