Kremezin Study Against Renal Disease Progression in Korea

NCT00860431 | Completed Phase 4 DMC

• 1 other identifier: 06-2008-355-0
• Study Type: interventional
• Target: 578
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

1

NO INTERVENTION

Standard-of-care (conservative treatment)

2

EXPERIMENTAL

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

Drug: AST-120

Interventions

AST-120 DRUG

6g/day (3 times a day)

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• HK inno.N Corporation: collaborator
• Kureha Corporation: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (2)

• 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.

  PMID: 29172403 DERIVED

• 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.

  PMID: 27249416 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

AST 120

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yon Su Kim, M.D.PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 12, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 19, 2014

Record last verified: 2014-03

Locations

KR (1)