NCT07182422 AST-120 (Kremezin®) for the Renal Protection and Attenuation of Decline in Acute Kidney Disease
| NCT ID | NCT07182422 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Acute Kidney Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2027-02-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2025-09-15 with a primary completion date of 2027-02-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07182422 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07182422 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07182422 currently recruiting?
Yes, NCT07182422 is actively recruiting participants. Contact the research team at franwisandsun@gmail.com for enrollment information.
Where is the NCT07182422 trial being conducted?
This trial is being conducted at Taoyuan, Taiwan.
Who is sponsoring the NCT07182422 clinical trial?
NCT07182422 is sponsored by Chang Gung Memorial Hospital. The trial plans to enroll 100 participants.
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