AST-120 (Kremezin) for kidney protection and slowing decline after acute kidney disease

Impact of Kremezin on Renal Recovery and Uremic Toxin Levels in Patients With Acute Kidney Disease

This study will test whether adding AST-120 (Kremezin) to standard care lowers protein-bound uremic toxins and helps slow kidney decline in adults recovering from acute kidney disease.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Chang Gung Memorial Hospital (Academic / other)
• Locations: 1 site (Taoyuan)
• Trial ID: NCT07182422 on ClinicalTrials.gov

What this trial studies

In this randomized, controlled Phase 4 trial, 100 adults with stage 2–3 acute kidney disease and post-discharge eGFR 30–60 ml/min/1.73m² will be assigned 1:1 to receive AST-120 (6 g/day) plus standard post-AKD care or standard care alone. Treatment is given for 14 days with measurements of indoxyl sulfate (IS), p-cresyl sulfate (p-CS), serum creatinine, eGFR, and urinary albumin-to-creatinine ratio at baseline, day 14, and follow-ups at day 90 and 180. The primary endpoint is percentage change in IS levels, with secondary endpoints including p-CS, renal function measures, and major adverse kidney events. Safety and adverse events will be monitored throughout the study period.

Who should consider this trial

Good fit: Adults aged 18–80 who recently experienced stage 2–3 AKD, were hospitalized for less than one month, and have post-discharge eGFR between 30 and 60 ml/min/1.73m² are potential candidates.

Not a fit: Patients with active cancer, AKD due to conditions that require ongoing inpatient management, or those who are bedridden, require tube feeding, long-term oxygen, or urinary catheters are excluded and unlikely to benefit from this outpatient intervention.

Why it matters

Potential benefit: If successful, AST-120 could lower toxin levels after AKD and help protect kidney function, potentially reducing progression to chronic kidney disease and associated cardiovascular risks.

How similar studies have performed: Prior studies of AST-120 in chronic kidney disease have shown reductions in protein-bound uremic toxins but have produced mixed results on clinical outcomes, making its use in AKD a relatively new application with limited outcome data.

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, 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.

Where this trial is running

Taoyuan

• Chang Gung Memorial Hospital, Taoyuan, Taiwan — Taoyuan, Taiwan (Recruiting)

Study contacts

• Study coordinator: Chih-Hsiang Chang

Conditions Acute Kidney Disease; Acute Kidney Injury; Progression from AKI to CKD