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AST-120 (Kremezin®) for the Renal Protection and Attenuation of Decline in Acute Kidney Disease

RecruitingPhase 4Ages 18 Years - 80 YearsAllChang Gung Memorial Hospital
NCT07182422 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 indoxyl sulfate (IS) and p-cresyl sulfate (p-CS), in patients with acute kidney disease (AKD). The trial aims to assess whether AST-120 can prevent further renal deterioration and slow the progression from AKD to chronic kidney disease (CKD) by mitigating the accumulation of PBUTs. Additionally, the study will investigate the potential of AST-120 to reduce the risk of CKD-associated complications, including cardiovascular disease, by reducing PBUT levels in AKD patients.

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📋 Eligibility rules (as published)
Inclusion/Exclusion Criteria： Inclusion criteria 1. Age between 18 and 80 years. 2. 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. 3. Post-discharge estimated glomerular filtration rate (eGFR) between 30 and 60 ml/min/1.73m², calculated using the MDRD equation. 4. Hospitalization duration not exceeding 1 month. Exclusion criteria 1. Patients with cancer or hematological malignancies. 2. 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.
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What it tests

  • AST-120 (Kremezin®)
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Where

1 site
Chang Gung Memorial Hospital, Taoyuan, Taiwan
Taoyuan, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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