Status:
RECRUITING
AST-120 (Kremezin®) for the Renal Protection and Attenuation of Decline in Acute Kidney Disease
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
Conmed Pharmaceutical & Bio-Medical Corporation
Conditions:
Acute Kidney Disease
Acute Kidney Injury (AKI)
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The primary goal of this clinical trial is to evaluate the efficacy of AST-120 (Kremezin®) in combination with standard care in reducing the levels of protein-bound uremic toxins (PBUTs), specifically...
Detailed Description
Study Procedures： 1. Total Number of Subjects The total number of subjects planned for enrollment is 100. The study will include two groups: 1. Experimental Group: 50 patients receiving AST-120 (6g...
Eligibility Criteria
Inclusion
- Inclusion/Exclusion Criteria： Inclusion criteria
- Age between 18 and 80 years.
- Diagnosis of acute kidney disease (AKD) during hospitalization, with AKD stage 2 or 3 according to the KDIGO-AKD criteria, defined by an increase in serum creatinine to 2 times or more from baseline within 7 to 90 days.
- Post-discharge estimated glomerular filtration rate (eGFR) between 30 and 60 ml/min/1.73m², calculated using the MDRD equation.
- Hospitalization duration not exceeding 1 month.
- Exclusion criteria
- Patients with cancer or hematological malignancies.
- Patients with AKD etiologies that cannot be managed in an outpatient setting (e.g., diabetic foot, obstructive uropathy with sepsis, cirrhosis).
- 1\. Patients presenting any of the following conditions, considered as excessively vulnerable populations or other conditions:
- Bedridden.
- Requiring nasogastric tube feeding.
- Long-term use of oxygen therapy.
- Use of urinary catheters.
- Patients unsuitable for AST-120 treatment, including:
- Patients with severe constipation (defined as requiring the daily use of more than one laxative).
- Patients with abnormal liver function (defined as ALT levels greater than 5 times the upper limit or total bilirubin \> 2mg/dL).
- Patients with a history of peptic ulcers within the last month.
- Pregnant women.
- Patients allergic to the study drug.
Exclusion
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 13 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07182422
Start Date
September 15 2025
End Date
March 13 2027
Last Update
September 19 2025
Active Locations (1)
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1
Chang Gung Memorial Hospital, Taoyuan, Taiwan
Taoyuan District, Taiwan, 333