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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chang Gung Memorial Hospital, Taoyuan, Taiwan
  Taoyuan, Taiwan Recruiting

Study contacts

• Study coordinator: Chih-Hsiang Chang
• Email: franwisandsun@gmail.com
• Phone: (03) 3196200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.