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

March 17, 2014 updated by: Seoul National University Hospital

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

  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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

578

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

HK inno.N Corporation
Kureha Corporation

Investigators

  • Principal Investigator: Yon Su Kim, M.D.PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 9, 2009

First Submitted That Met QC Criteria

March 11, 2009

First Posted (Estimate)

March 12, 2009

Study Record Updates

Last Update Posted (Estimate)

March 19, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-2008-355-0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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