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Kremezin Study Against Renal Disease Progression in Korea

NCT00860431 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 578

Last updated 2014-03-19

No results posted yet for this study

Summary

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)

Conditions

Interventions

DRUG

AST-120

6g/day (3 times a day)

Sponsors & Collaborators

  • HK inno.N Corporation

    collaborator INDUSTRY

  • Kureha Corporation

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Yon Su Kim, M.D.PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00860431 on ClinicalTrials.gov