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Recruiting Phase 4 NCT07182422

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

Trial Parameters

Condition Acute Kidney Disease
Sponsor Chang Gung Memorial Hospital
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2025-09-15
Completion 2027-02-11
Interventions
AST-120 (Kremezin®)

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 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.

Eligibility Criteria

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, includin

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