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

NCT07182422 | Recruiting Phase 4

• 1 other identifier: 202401872A3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Disease; Acute Kidney Injury (AKI)

Keywords

Acute Kidney Disease (AKD); Acute Kidney Injury (AKI); Progression from AKI to CKD

Outcome Measures

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.

  Day 0, Day 14, Day 90, Day 180

Secondary Outcomes (4)

• Change in serum p-cresyl sulfate (p-CS) concentration

  Day 0, Day 14, Day 90, Day 180

• Change in estimated glomerular filtration rate (eGFR)

  Day 0, Day 14, Day 90, Day 180

• Change in urine albumin/creatinine ratio (UACR)

  Day 0, Day 14, Day 90, Day 180

• Change in urine total protein/creatinine ratio (UPCR)

  Day 0, Day 14, Day 90, Day 180

Study Arms (2)

Control

NO INTERVENTION

Control (Standard Care Only) Intervention: Standard post-AKD care No AST-120

Experimental (AST-120 + Standard Care)

EXPERIMENTAL

Intervention: AST-120 (Kremezin®) Dosage: 6 g/day (2 g TID, oral) Duration: 14 days Background treatment: Standard post-AKD care

Drug: AST-120 (Kremezin®)

Interventions

AST-120 (Kremezin®) DRUG

AST-120 (Kremezin®) Dosage: 6 g/day (2 g TID, oral) Duration: 14 days Background treatment: Standard post-AKD care

Experimental (AST-120 + Standard Care)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• Patients with cancer or hematological malignancies.
• Patients with AKD etiologies that cannot be managed in an outpatient setting (e.g., diabetic foot, obstructive uropathy with sepsis, cirrhosis).
• \. 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Conmed Pharmaceutical & Bio-Medical Corporation: collaborator

Study Sites (1)

Chang Gung Memorial Hospital, Taoyuan, Taiwan

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (13)

• Caillard P, Bennis Y, Six I, Bodeau S, Kamel S, Choukroun G, Maizel J, Titeca-Beauport D. The Role of Gut-Derived, Protein-Bound Uremic Toxins in the Cardiovascular Complications of Acute Kidney Injury. Toxins (Basel). 2022 May 11;14(5):336. doi: 10.3390/toxins14050336.

  PMID: 35622583 BACKGROUND

• Yamamoto S, Kazama JJ, Omori K, Matsuo K, Takahashi Y, Kawamura K, Matsuto T, Watanabe H, Maruyama T, Narita I. Continuous Reduction of Protein-Bound Uraemic Toxins with Improved Oxidative Stress by Using the Oral Charcoal Adsorbent AST-120 in Haemodialysis Patients. Sci Rep. 2015 Sep 23;5:14381. doi: 10.1038/srep14381.

  PMID: 26395517 BACKGROUND

• Nagata D, Yoshizawa H. Pharmacological Actions of Indoxyl Sulfate and AST-120 That Should Be Recognized for the Strategic Treatment of Patients with Chronic Kidney Disease. Int J Nephrol Renovasc Dis. 2020 Dec 4;13:359-365. doi: 10.2147/IJNRD.S287237. eCollection 2020.

  PMID: 33311993 BACKGROUND

• Shen WC, Chou YH, Shi LS, Chen ZW, Tu HJ, Lin XY, Wang GJ. AST-120 Improves Cardiac Dysfunction in Acute Kidney Injury Mice via Suppression of Apoptosis and Proinflammatory NF-kappaB/ICAM-1 Signaling. J Inflamm Res. 2021 Feb 24;14:505-518. doi: 10.2147/JIR.S283378. eCollection 2021.

  PMID: 33658826 BACKGROUND

• Lim YJ, Sidor NA, Tonial NC, Che A, Urquhart BL. Uremic Toxins in the Progression of Chronic Kidney Disease and Cardiovascular Disease: Mechanisms and Therapeutic Targets. Toxins (Basel). 2021 Feb 13;13(2):142. doi: 10.3390/toxins13020142.

  PMID: 33668632 BACKGROUND

• Espi M, Koppe L, Fouque D, Thaunat O. Chronic Kidney Disease-Associated Immune Dysfunctions: Impact of Protein-Bound Uremic Retention Solutes on Immune Cells. Toxins (Basel). 2020 May 6;12(5):300. doi: 10.3390/toxins12050300.

  PMID: 32384617 BACKGROUND

• Schulman G, Berl T, Beck GJ, Remuzzi G, Ritz E, Arita K, Kato A, Shimizu M. Randomized Placebo-Controlled EPPIC Trials of AST-120 in CKD. J Am Soc Nephrol. 2015 Jul;26(7):1732-46. doi: 10.1681/ASN.2014010042. Epub 2014 Oct 27.

  PMID: 25349205 BACKGROUND

• Sun CY, Chang SC, Wu MS. Suppression of Klotho expression by protein-bound uremic toxins is associated with increased DNA methyltransferase expression and DNA hypermethylation. Kidney Int. 2012 Apr;81(7):640-50. doi: 10.1038/ki.2011.445. Epub 2012 Jan 11.

  PMID: 22237753 BACKGROUND

• Chen JH, Chiang CK. Uremic Toxins and Protein-Bound Therapeutics in AKI and CKD: Up-to-Date Evidence. Toxins (Basel). 2021 Dec 23;14(1):8. doi: 10.3390/toxins14010008.

  PMID: 35050985 BACKGROUND

• Sun CY, Hsu HH, Wu MS. p-Cresol sulfate and indoxyl sulfate induce similar cellular inflammatory gene expressions in cultured proximal renal tubular cells. Nephrol Dial Transplant. 2013 Jan;28(1):70-8. doi: 10.1093/ndt/gfs133. Epub 2012 May 18.

  PMID: 22610984 BACKGROUND

• Barreto FC, Barreto DV, Liabeuf S, Meert N, Glorieux G, Temmar M, Choukroun G, Vanholder R, Massy ZA; European Uremic Toxin Work Group (EUTox). Serum indoxyl sulfate is associated with vascular disease and mortality in chronic kidney disease patients. Clin J Am Soc Nephrol. 2009 Oct;4(10):1551-8. doi: 10.2215/CJN.03980609. Epub 2009 Aug 20.

  PMID: 19696217 BACKGROUND

• Schulman G, Vanholder R, Niwa T. AST-120 for the management of progression of chronic kidney disease. Int J Nephrol Renovasc Dis. 2014 Jan 30;7:49-56. doi: 10.2147/IJNRD.S41339. eCollection 2014.

  PMID: 24501542 BACKGROUND

• Levey AS. Defining AKD: The Spectrum of AKI, AKD, and CKD. Nephron. 2022;146(3):302-305. doi: 10.1159/000516647. Epub 2021 Jun 24.

  PMID: 34167119 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

AST 120

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Chih-Hsiang Chang

CONTACT

(03) 3196200; franwisandsun@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Experimental Group (AST-120 Treatment Group): * Drug: AST-120 (Kremezin®) * Dosage: 6 grams per day * Administration: Oral administration, in the form of 1 packet (2 grams) three times per day (TID) * Frequency: Three times daily, preferably with meals * Duration: 14 days of continuous treatment * Background Treatment: In addition to AST-120, participants will receive standard post-AKD care, including the avoidance of nephrotoxic agents and regular monitoring of renal function. 2. Control Group (Standard Post-AKD Care Only): * Treatment: Participants will receive only standard post-AKD care, which involves: * Avoidance of nephrotoxic medications * Regular monitoring of renal function (e.g., serum creatinine and eGFR assessments) * Other supportive therapies as deemed necessary based on individual patient conditions * Duration: The control group will be monitored for the same 14-day period as the experimental group, with regular follow-ups.

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 19, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): February 11, 2027
• Study Completion (Estimated): March 13, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)