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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AST-120
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

Standard-of-care (conservative treatment)

AST-120 6g/day (3 times a day)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

change of estimated GFR and urine protein excretion, Assessment of health related quality of life, all-cause mortality

Full Information

First Posted
March 9, 2009
Last Updated
March 17, 2014
Sponsor
Seoul National University Hospital
Collaborators
HK inno.N Corporation, Kureha Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00860431
Brief Title
Kremezin Study Against Renal Disease Progression in Korea
Acronym
K-STAR
Official Title
K-STAR (Kremezin STudy Against Renal Disease Progression in Korea) Randomized, Open-label, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital
Collaborators
HK inno.N Corporation, Kureha Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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; To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to GFR and proteinuria; To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to health related quality of life; To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; To evaluate the all-cause mortality and hospitalization apart from those planned for operation and intervention)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
578 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Standard-of-care (conservative treatment)
Arm Title
2
Arm Type
Experimental
Arm Description
AST-120 6g/day (3 times a day)
Intervention Type
Drug
Intervention Name(s)
AST-120
Intervention Description
6g/day (3 times a day)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yon Su Kim, M.D.PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29172403
Citation
Baek SH, Cha RH, Kang SW, Park CW, Cha DR, Kim SG, Yoon SA, Kim S, Han SY, Park JH, Chang JH, Lim CS, Kim YS, Na KY. Circulating renalase predicts all-cause mortality and renal outcomes in patients with advanced chronic kidney disease. Korean J Intern Med. 2019 Jul;34(4):858-866. doi: 10.3904/kjim.2017.058. Epub 2017 Nov 29.
Results Reference
derived
PubMed Identifier
27249416
Citation
Lee SW, Kim S, Na KY, Cha RH, Kang SW, Park CW, Cha DR, Kim SG, Yoon SA, Han SY, Park JH, Chang JH, Lim CS, Kim YS. Serum Anion Gap Predicts All-Cause Mortality in Patients with Advanced Chronic Kidney Disease: A Retrospective Analysis of a Randomized Controlled Study. PLoS One. 2016 Jun 1;11(6):e0156381. doi: 10.1371/journal.pone.0156381. eCollection 2016.
Results Reference
derived

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Kremezin Study Against Renal Disease Progression in Korea

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