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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
AST-120 (Kremezin®)
DrugAST-120 (Kremezin®) Dosage: 6 g/day (2 g TID, oral) Duration: 14 days Background treatment: Standard post-AKD care
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Experimental (AST-120 + Standard Care)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in serum indoxyl sulfate (IS) concentration
Change in serum indoxyl sulfate (IS) concentration Time Frame: Baseline to Day 180 Description: Evaluate reduction in IS levels after AST-120 treatment compared to control.
Time frame
Day 0, Day 14, Day 90, Day 180Secondary outcomes
1
Change in serum p-cresyl sulfate (p-CS) concentration
Change in serum p-cresyl sulfate (p-CS) concentration Time Frame: Baseline to Day 180 Assess difference in p-CS levels between groups.
Time frame
Day 0, Day 14, Day 90, Day 1802
Change in estimated glomerular filtration rate (eGFR)
Change in estimated glomerular filtration rate (eGFR) Time Frame: Baseline to Day 180 Description: Evaluate reduction in eGFR after AST-120 treatment compared to control.
Time frame
Day 0, Day 14, Day 90, Day 1803
Change in urine albumin/creatinine ratio (UACR)
Change in urine albumin/creatinine ratio (UACR) Time Frame: Baseline to Day 180 Description: Evaluate reduction inUACR after AST-120 treatment compared to control.
Time frame
Day 0, Day 14, Day 90, Day 1804
Change in urine total protein/creatinine ratio (UPCR)
Change in urine total protein/creatinine ratio (UPCR) Time Frame: Baseline to Day 180 Description: Evaluate reduction in UPCR after AST-120 treatment compared to control.
Time frame
Day 0, Day 14, Day 90, Day 180Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chang Gung Memorial Hospital
Lead sponsor
Conmed Pharmaceutical & Bio-Medical Corporation
Collaborator
Source ClinicalTrials.gov