K-STAR (Kremezin STudy Against Renal Disease Progression in Korea) Randomized, Open-label, Controlled Study
| Registry | NCT00860431, acronym K-STAR |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 578 (Estimated) |
| Sponsor | Seoul National University Hospital (Other); collaborators: HK inno.N Corporation, Kureha Corporation |
| Conditions | Chronic Kidney Disease |
| Interventions | AST-120 (Drug) |
| Dates | start 2009-03-01, primary completion 2013-09-01, completion 2013-09-01, first posted 2009-03-12, last updated 2014-03-19 |
| Locations | 1 site in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Kidney Disease All trials of AST-120
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)
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 1 | No intervention | Standard-of-care (conservative treatment) | |
| 2 | Experimental | Drug: AST-120 | AST-120 6g/day (3 times a day) |
Sex: All, ages: 18 Years to any
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |