Kremezin Study Against Renal Disease Progression in Korea

Chronic Kidney Disease Clinical Trial

— K-STAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860431
• Other study ID #: 06-2008-355-0
• Status: Completed
• Phase: Phase 4
• First received: March 9, 2009
• Last updated: March 17, 2014
• Start date: March 2009
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 578
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Disease Progression
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	CJ HealthCare Corporation, Kureha Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Yes
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)	Yes