Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT07182422

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

Led by Chang Gung Memorial Hospital · Updated on 2025-09-19

100

Participants Needed

1

Research Sites

77 weeks

Total Duration

On this page

Sponsors

C

Chang Gung Memorial Hospital

Lead Sponsor

C

Conmed Pharmaceutical & Bio-Medical Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years
  • Diagnosed with acute kidney disease (AKD) stage 2 or 3 based on KDIGO-AKD criteria
  • Post-discharge estimated glomerular filtration rate (eGFR) between 30 and 60 ml/min/1.73m8
  • Hospitalization duration no longer than 1 month
Not Eligible

You will not qualify if you...

  • Presence of cancer or hematological malignancies
  • AKD causes that require inpatient management (e.g., diabetic foot, obstructive uropathy with sepsis, cirrhosis)
  • Being bedridden, needing nasogastric tube feeding, long-term oxygen therapy, or using urinary catheters
  • Severe constipation requiring daily use of more than one laxative
  • Abnormal liver function (ALT > 5 times upper limit or total bilirubin > 2 mg/dL)
  • History of peptic ulcers within the last month
  • Pregnancy
  • Allergy to AST-120 (Kremezin4)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chang Gung Memorial Hospital, Taoyuan, Taiwan

Taoyuan, Taiwan, 333

Actively Recruiting

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Research Team

C

Chih-Hsiang Chang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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