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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChang Gung Memorial Hospital

About this trial

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

Qualifiers

None

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • AST-120 (Kremezin®)

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Chang Gung Memorial Hospital

Lead sponsor

Conmed Pharmaceutical & Bio-Medical Corporation

Collaborator