Kremezin Study Against Renal Disease Progression in Korea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

578 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-09-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Standard-of-care (conservative treatment)

Group Type NO_INTERVENTION

No interventions assigned to this group

2

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

Group Type EXPERIMENTAL

AST-120

Intervention Type DRUG

6g/day (3 times a day)

Interventions

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AST-120

6g/day (3 times a day)

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No