| Trial ID: | L0244 |
| Source ID: | NCT00860431
|
| Associated Drug: |
Ast-120
|
| Title: |
Kremezin Study Against Renal Disease Progression in Korea
|
| Acronym: |
K-STAR
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: AST-120
|
| Outcome Measures: |
Primary: 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), approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up) | Secondary: change of estimated GFR and urine protein excretion, Assessment of health related quality of life, all-cause mortality, approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up)
|
| Sponsor/Collaborators: |
Sponsor: Seoul National University Hospital | Collaborators: HK inno.N Corporation|Kureha Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
578
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-03
|
| Completion Date: |
2013-09
|
| Results First Posted: |
|
| Last Update Posted: |
2014-03-19
|
| Locations: |
Seoul National University Hospital, Seoul, 110-744, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT00860431
|
