Acute Kidney DiseasePhase 4ASTRA-AKDNCT07182422
AST-120 (Kremezin®) for the Renal Protection and Attenuation of Decline in Acute Kidney Disease
A Phase 4 study testing AST-120 (Kremezin®) in people with Acute Kidney Disease and Acute Kidney Injury (AKI), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Disease, Acute Kidney Injury (AKI)
- What is being tested?
- AST-120 (Kremezin®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Sep 2025to 13 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Taoyuan, Taiwan
Taoyuan, 333
Chih-Hsiang Chang, +886 3 3281200 ext. 7761, franwisandsun@gmail.com
Ming-Jen Chan, MD, +886 3 3281200 ext. 2680, b9202066@cgmh.org.tw
About this study
Official title: Impact of Kremezin on Renal Recovery and Uremic Toxin Levels in Patients With Acute Kidney Disease
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.
Read the detailed description
Study Procedures：
- Total Number of Subjects The total number of subjects planned for enrollment is 100.
The study will include two groups:
- Experimental Group: 50 patients receiving AST-120 (6g/day) in combination with standard post-AKD care.
- Control Group: 50 patients receiving only standard post-AKD care. The sample size is determined based on the statistical power needed to detect a significant difference in the primary endpoint (percentage changes in IS levels), with consideration for potential dropout rates. The evaluable number is estimated to be close to 90, allowing for a 10% dropout rate, making the enrolled number 100.
- Interventions, Procedures, and Tests for Each Group
Subjects will undergo the following interventions, procedures, and tests according to the schedule:
- Baseline (Day 0):
- Demographic data collection.
- Blood tests for serum creatinine, eGFR, IS, p-CS, and urinary albumin-to-creatinine ratio (UACR).
- Randomization into experimental or control groups.
- Treatment Period (Day 1-14):
- Experimental Group: Receive AST-120 (6g/day, divided into three doses per day).
- Control Group: Standard post-AKD care only.
- Both groups will undergo regular clinical assessments and adverse event monitoring.
- Day 14:
- Blood tests for IS, p-CS, serum creatinine, eGFR, and UACR.
- Follow-up (Day 90 and Day 180):
- Assess eGFR, serum creatinine, UACR.
- Monitor for major adverse kidney events (MAKE) and major adverse cardiovascular events (MACE).
- Trial Procedure Timeline
The trial procedure follows this timeline:
- Day 0: Baseline measurements and randomization.
- Day 1-14: Treatment phase (AST-120 administration or standard care).
- Day 14: Blood tests and assessment of treatment efficacy.
- Day 90 and Day 180: Follow-up visits for MAKE and MACE assessments, and blood tests for kidney function.
- Specimen Collection and Processing
- Specimen: Blood samples will be collected on Day 0 (baseline), Day 14 (end of treatment), Day 90, and Day 180 (follow-up).
- Transport and Storage: Specimens will be transported to the laboratory within the hospital for immediate processing. They will be stored in a temperature-controlled facility if needed.
- Processing: Blood samples will undergo centrifugation for serum separation. Serum will be used for measuring IS, p-CS, serum creatinine, and other biomarkers.
- Analysis: The following tests will be performed:
- IS and p-CS levels.
- Serum creatinine and eGFR.
- UACR.
- Clinical Data Collection and Questionnaires
Clinical data collected will include:
- Demographic data (age, sex, medical history).
- Lab results for IS, p-CS, creatinine, eGFR, UACR. No specific questionnaires will be used for this study.
- Conditions
- Acute Kidney Disease, Acute Kidney Injury (AKI)
- Being tested
- AST-120 (Kremezin®)
- Keywords
- Acute Kidney Disease (AKD), Acute Kidney Injury (AKI), Progression from AKI to CKD
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-120 (Kremezin®)Drug
AST-120 (Kremezin®) Dosage: 6 g/day (2 g TID, oral) Duration: 14 days Background treatment: Standard post-AKD care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: AST-120 (Kremezin®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0, Day 14, Day 90, Day 180
Secondary outcomes (4)
Change in serum p-cresyl sulfate (p-CS) concentration
Change in serum p-cresyl sulfate (p-CS) concentration Time Frame: Baseline to Day 180 Assess difference in p-CS levels between groups.
Measured: Day 0, Day 14, Day 90, Day 180
Change in estimated glomerular filtration rate (eGFR)
Change in estimated glomerular filtration rate (eGFR) Time Frame: Baseline to Day 180 Description: Evaluate reduction in eGFR after AST-120 treatment compared to control.
Measured: Day 0, Day 14, Day 90, Day 180
Change in urine albumin/creatinine ratio (UACR)
Change in urine albumin/creatinine ratio (UACR)
Time Frame: Baseline to Day 180
Description: Evaluate reduction inUACR after AST-120 treatment compared to control.
Measured: Day 0, Day 14, Day 90, Day 180
Change in urine total protein/creatinine ratio (UPCR)
Change in urine total protein/creatinine ratio (UPCR) Time Frame: Baseline to Day 180 Description: Evaluate reduction in UPCR after AST-120 treatment compared to control.
Measured: Day 0, Day 14, Day 90, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion11 Feb 2027 (estimated)
- Study completion13 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conmed Pharmaceutical & Bio-Medical Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182422
- Sponsor's protocol ID
- 202401872A3
- Acronym
- ASTRA-AKD
- Status last verified
- May 2025
- First submitted
- 4 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35622583Yamamoto 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.
PubMed 26395517Nagata 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.
PubMed 33311993Shen 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.
PubMed 33658826Lim 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.
PubMed 33668632Espi 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.
PubMed 32384617Schulman 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.
PubMed 25349205Sun 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.
PubMed 22237753Chen 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.
PubMed 35050985Sun 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.
PubMed 22610984Barreto 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.
PubMed 19696217Schulman 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.
PubMed 24501542Levey AS. Defining AKD: The Spectrum of AKI, AKD, and CKD. Nephron. 2022;146(3):302-305. doi: 10.1159/000516647. Epub 2021 Jun 24.
PubMed 34167119
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Kremezin on Renal Recovery and Uremic Toxin Levels in Patients With Acute Kidney Disease
- ClinicalTrials.gov ID
- NCT07182422
- Acronym / sponsor ID
- ASTRA-AKD / 202401872A3
- Conditions
- Acute Kidney Disease, Acute Kidney Injury (AKI)
- Keywords
- Acute Kidney Disease (AKD), Acute Kidney Injury (AKI), Progression from AKI to CKD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Conmed Pharmaceutical & Bio-Medical Corporation
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 11 Feb 2027 (estimated)
- Study completion
- 13 Mar 2027 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Procedures：
- Total Number of Subjects The total number of subjects planned for enrollment is 100.
The study will include two groups:
- Experimental Group: 50 patients receiving AST-120 (6g/day) in combination with standard post-AKD care.
- Control Group: 50 patients receiving only standard post-AKD care. The sample size is determined based on the statistical power needed to detect a significant difference in the primary endpoint (percentage changes in IS levels), with consideration for potential dropout rates. The evaluable number is estimated to be close to 90, allowing for a 10% dropout rate, making the enrolled number 100.
- Interventions, Procedures, and Tests for Each Group
Subjects will undergo the following interventions, procedures, and tests according to the schedule:
- Baseline (Day 0):
- Demographic data collection.
- Blood tests for serum creatinine, eGFR, IS, p-CS, and urinary albumin-to-creatinine ratio (UACR).
- Randomization into experimental or control groups.
- Treatment Period (Day 1-14):
- Experimental Group: Receive AST-120 (6g/day, divided into three doses per day).
- Control Group: Standard post-AKD care only.
- Both groups will undergo regular clinical assessments and adverse event monitoring.
- Day 14:
- Blood tests for IS, p-CS, serum creatinine, eGFR, and UACR.
- Follow-up (Day 90 and Day 180):
- Assess eGFR, serum creatinine, UACR.
- Monitor for major adverse kidney events (MAKE) and major adverse cardiovascular events (MACE).
- Trial Procedure Timeline
The trial procedure follows this timeline:
- Day 0: Baseline measurements and randomization.
- Day 1-14: Treatment phase (AST-120 administration or standard care).
- Day 14: Blood tests and assessment of treatment efficacy.
- Day 90 and Day 180: Follow-up visits for MAKE and MACE assessments, and blood tests for kidney function.
- Specimen Collection and Processing
- Specimen: Blood samples will be collected on Day 0 (baseline), Day 14 (end of treatment), Day 90, and Day 180 (follow-up).
- Transport and Storage: Specimens will be transported to the laboratory within the hospital for immediate processing. They will be stored in a temperature-controlled facility if needed.
- Processing: Blood samples will undergo centrifugation for serum separation. Serum will be used for measuring IS, p-CS, serum creatinine, and other biomarkers.
- Analysis: The following tests will be performed:
- IS and p-CS levels.
- Serum creatinine and eGFR.
- UACR.
- Clinical Data Collection and Questionnaires
Clinical data collected will include:
- Demographic data (age, sex, medical history).
- Lab results for IS, p-CS, creatinine, eGFR, UACR. No specific questionnaires will be used for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control (Standard Care Only) Intervention: Standard post-AKD care No AST-120 |
| Experimental (AST-120 + Standard Care) | Experimental | Drug: AST-120 (Kremezin®)Intervention: AST-120 (Kremezin®) Dosage: 6 g/day (2 g TID, oral) Duration: 14 days Background treatment: Standard post-AKD care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
- 1. Patients presenting any of the following conditions, considered as excessively vulnerable populations or other conditions:
- Bedridden.
- Requiring nasogastric tube feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AST-120 (Kremezin®)AST-120 (Kremezin®) Dosage: 6 g/day (2 g TID, oral) Duration: 14 days Background treatment: Standard post-AKD care | Drug | Experimental (AST-120 + Standard Care) |
Primary outcome
Change in serum indoxyl sulfate (IS) concentration
Time frame: Day 0, Day 14, Day 90, Day 180
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.
4 secondary outcomes
Change in serum p-cresyl sulfate (p-CS) concentration
Time frame: Day 0, Day 14, Day 90, Day 180
Change in estimated glomerular filtration rate (eGFR)
Time frame: Day 0, Day 14, Day 90, Day 180
Change in urine albumin/creatinine ratio (UACR)
Time frame: Day 0, Day 14, Day 90, Day 180
Change in urine total protein/creatinine ratio (UPCR)
Time frame: Day 0, Day 14, Day 90, Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 35622583Caillard 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.
- Background: PubMed 26395517Yamamoto 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.
- Background: PubMed 33311993Nagata 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.
- Background: PubMed 33658826Shen 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.
- Background: PubMed 33668632Lim 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.
- Background: PubMed 32384617Espi 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.
- Background: PubMed 25349205Schulman 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.
- Background: PubMed 22237753Sun 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.
- Background: PubMed 35050985Chen 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.
- Background: PubMed 22610984Sun 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.
- Background: PubMed 19696217Barreto 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.
- Background: PubMed 24501542Schulman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AST-120 (Kremezin®) in people with Acute Kidney Disease and Acute Kidney Injury (AKI), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Hsiang Chang ((03) 3196200 ext. 7761, franwisandsun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum indoxyl sulfate (IS) concentration (time frame: Day 0, Day 14, Day 90, Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07182422, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.