Oral Uremic Toxin AbsorbentNCT07333313
Study of Oral Uremic Toxin Absorbent/Probiotics to Modulate Systemic Inflammation and Retard the Progression of Chronic Kidney Disease in Patients With Diabetes.
A study testing oral uremic toxin absorbent, probiotics and oral uremic toxin absorbent + probiotics in people with Oral Uremic Toxin Absorbent, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Diabetes mellitus (DM) is a chronic inflammatory disease characterized by insufficient insulin secretion or insulin resistance, leading to hyperglycemia. Chronic inflammation and immune system dysfunction are characteristic of DM and can produce a plethora of cytokines and chemokines, thereby contributing to diabetic… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Oral Uremic Toxin Absorbent
- What is being tested?
- oral uremic toxin absorbent, probiotics and oral uremic toxin absorbent + probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Dec 2024to 31 Dec 2029
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 20 years old but not pregnant on the day of screening.
- DKD patients with stable renal function (Cre elevation < 0.3 mg/dL for at least 30 days) and PCS level (fluctuation < 10% for at least 30 days)
- Group 1: 120 DKD patients with 45<eGFR<60 ml/min/1.73m2 in stable status. Group 2: 120 DKD patients with 30<eGFR<45 ml/min/1.73m2 in stable status. Group 3: 60 DKD patients with 15<eGFR<30 ml/min/1.73m2 in stable status Group 4: 60 DKD patients with eGFR<15 ml/min/1.73m2 in stable status
Who cannot join
- Baseline eGFR > 90 ml/min/1.73m2 according to MDRD equation.
- Patients in severe malnutrition status, albumin less than 2.0 g/dL.
- Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin < 8 g/dL.
- Active peptic ulcer, esophageal varices, ileus or under fasting status
- Previous gastrointestinal operation.
- Chronic constipation, as defined with less than 3 bowel movements per week, straining, hard stools.
Show all 14Show fewer
- Incomplete evacuation and inability to pass stool. If usage of oral laxatives can achieve bowel movement, this patient will not be excluded.
- Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.
- Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C.
- Solid organ or hematological transplantation recipients.
- Evidence of obstructive kidney injury or polycystic kidney disease.
- Presence or history of malignant neoplasms within the past 5 years prior to the day of screening.
- Patients with Immune Deficiency Syndrome.
- Antibiotics or probiotics treatment within the last 3 months before enrollment and during follow-up period.
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
National Taiwan University Hospital.
Taipei, Taiwan, 10002
chauchung wu, PhD, 886-2-23123456 ext. #288559, chauchungwu@ntu.edu.tw
About this study
Diabetes mellitus (DM) is a chronic inflammatory disease characterized by insufficient insulin secretion or insulin resistance, leading to hyperglycemia. Chronic inflammation and immune system dysfunction are characteristic of DM and can produce a plethora of cytokines and chemokines, thereby contributing to diabetic complications such as cardiovascular events and diabetic vasculopathy in DM. Besides, about 25% of people with diabetes eventually develop diabetic kidney disease (DKD). DKD is a consequence of DM with chronic kidney disease (CKD), which may abruptly increase cardiovascular disease (CVD) and its mortality rate compared with diabetes alone. Therefore, the modulation of the systemic inflammation may have the opportunity to improve both hyperglycemia and diabetic complications including vasculopathy and DKD.
Activated charcoal has been used clinically as a toxin absorbent. Some recent preclinical and clinical observations found the potential benefits and diverse effects of activated charcoal on inflammatory proteins, suggesting its potential immune modulation effects in CKD and related diseases. The current project is then designed to test the hypothesis that oral activated charcoal may be used as an anti-inflammatory strategy for diabetic complications especially DKD. We have recently demonstrated the renal protective effects of a new oral form of non-absorbable activated bamboo charcoal (ABC) in an animal model.
Read more
With OMICs studies, a growing preclinical and clinical evidence supports the theory that gut microbiome is a major contributor to adverse cardiovascular outcomes and progression of CKD, and the gut microbiota and its metabolites have the potential to be a novel therapeutic and preventative target for CKD. Additionally, current finding suggests that lncRNAs are involved in cardiovascular (CV) health and diseases. However, there is no report on the impact of gut microbiota on the host circulating lncRNA expression signature and the potential link between gut microbiota, circulating lncRNA levels changes and CKD. Although studies of probiotics which have benefits of CKD patients are numerous, few studies evaluated the effect of coadministration of activated charcoal/probiotics on the patients with CKD.
In this 12-month trial, 120 DKD subjects will be enrolled for each group (CKD group 1: CKD stage 3A; group 2: CKD stage 3B; group 3: CKD stage 4; and group 4: CKD stage 5). Each group of patients will be randomized into 6 subgroups A, B, C, D, E and F. Group A patients will receive ABC 2.3g three times a day in addition to standard care in the first 6 months, but group B patients will receive the same dosage of ABC in the last 6 months. Group C patients will receive probiotics 2g twice a day in addition to standard care in the first 6 months, but group D patients will receive the same dosage of probiotics in the last 6 months. Group E patients will receive ABC 2.3g three times a day and probiotics 2g twice a day in addition to standard care in the first 6 months, but group F patients will receive the same dosage of ABC and probiotics in the last 6 months. All patients will receive clinical assessments and examinations (gut microbiota, inflammatory proteins including CCL4, long-chain noncoding (lnc)RNAs, and uremic toxins) at baseline and every 3 months thereafter for 12 months.
- Conditions
- Oral Uremic Toxin Absorbent
- Being tested
- oral uremic toxin absorbent, probiotics, oral uremic toxin absorbent + probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral uremic toxin absorbentDietary supplement
In this 12-month trial, 300 DKD participants will be enrolled (60 with CKD stage 3A, 60 with stage 3B, 60 with stage 4, and 60 with stage 5 or on dialysis). Within each stage, participants will be randomized into three subgroups (A-C). Group A will receive ABC 2.3 g three times daily together with standard care during the last 6 months. Group B will receive probiotics 2 g twice daily during the last 6 months. Group C will receive both interventions during the last 6 months. Clinical assessments and examinations- including gut microbiota, inflammatory proteins (e.g., CCL4), long non-coding RNAs (lncRNAs), and uremic toxins- will be conducted at baseline and every 3 months for 12 months.
probioticsDietary supplement
In this 12-month trial, 300 DKD participants will be enrolled (60 with CKD stage 3A, 60 with stage 3B, 60 with stage 4, and 60 with stage 5 or on dialysis). Within each stage, participants will be randomized into three subgroups (A-C). Group A will receive ABC 2.3 g three times daily together with standard care during the last 6 months. Group B will receive probiotics 2 g twice daily during the last 6 months. Group C will receive both interventions during the last 6 months. Clinical assessments and examinations- including gut microbiota, inflammatory proteins (e.g., CCL4), long non-coding RNAs (lncRNAs), and uremic toxins- will be conducted at baseline and every 3 months for 12 months.
oral uremic toxin absorbent + probioticsDietary supplement
In this 12-month trial, 300 DKD participants will be enrolled (60 with CKD stage 3A, 60 with stage 3B, 60 with stage 4, and 60 with stage 5 or on dialysis). Within each stage, participants will be randomized into three subgroups (A-C). Group A will receive ABC 2.3 g three times daily together with standard care during the last 6 months. Group B will receive probiotics 2 g twice daily during the last 6 months. Group C will receive both interventions during the last 6 months. Clinical assessments and examinations- including gut microbiota, inflammatory proteins (e.g., CCL4), long non-coding RNAs (lncRNAs), and uremic toxins- will be conducted at baseline and every 3 months for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| oral uremic toxin absorbent | Other | Based on these previous findings, we will conduct a prospective randomized open blinded end-point (PROBE) study to see if oral uremic toxin absorbent + probiotics to modulate systemic inflammation and retard the progression of chronic kidney disease in patients with diabetes. Receives: Dietary Supplement: oral uremic toxin absorbent |
| probiotics | Other | Based on these previous findings, we will conduct a prospective randomized open blinded end-point (PROBE) study to see if oral uremic toxin absorbent + probiotics to modulate systemic inflammation and retard the progression of chronic kidney disease in patients with diabetes. Receives: Dietary Supplement: probiotics |
| oral uremic toxin absorbent +/- probiotics | Experimental | Dietary Supplement: Oral Uremic Toxin Absorbent/Probiotics This 12-month trial will enroll 120 subjects with Diabetic Kidney Disease (DKD), consisting of 60 subjects in CKD Stage 3A, 60 in Stage 3B, 60 in Stage 4, and 60 in Stage 5/dialysis.
Each group will be randomized into six subgroups (A-F):
Group A: Administered 2.3g of ABC three times daily during the latter 6 months.
Group B: Administered 2g of probiotics twice daily during the latter 6 months.
Group C: Administered a combination of oral uremic toxin absorbent/probiotics during the latter 6 months.
Clinical evaluations and examinations will be performed at baseline and every 3 months over the 12-month duration, including gut microbiota, inflammatory proteins (e.g., CCL4), long non-coding RNA (lncRNA), and uremic toxins. Receives: Dietary Supplement: oral uremic toxin absorbent + probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of eGFR
eGFR is estimated GFR calculated by the abbreviated MDRD equation : 186 x (Creatinine/88.4)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if black).
Measured: -6th month,-3th month,baseline,random, 3th month and 6th month
Secondary outcomes (1)
The change of UACR
Urine albumin divided by urine creatinine
Measured: baseline, 3th month and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start31 Dec 2024
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Uremic Toxin AbsorbentStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333313
- Sponsor's protocol ID
- 202405001RINE
- Status last verified
- Jan 2026
- First submitted
- 15 Jul 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Oral Uremic Toxin Absorbent/Probiotics to Modulate Systemic Inflammation and Retard the Progression of Chronic Kidney Disease in Patients With Diabetes.
- ClinicalTrials.gov ID
- NCT07333313
- Acronym / sponsor ID
- 202405001RINE
- Conditions
- Oral Uremic Toxin Absorbent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Jan 2026 (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.
Diabetes mellitus (DM) is a chronic inflammatory disease characterized by insufficient insulin secretion or insulin resistance, leading to hyperglycemia. Chronic inflammation and immune system dysfunction are characteristic of DM and can produce a plethora of cytokines and chemokines, thereby contributing to diabetic complications such as cardiovascular events and diabetic vasculopathy in DM. Besides, about 25% of people with diabetes eventually develop diabetic kidney disease (DKD). DKD is a consequence of DM with chronic kidney disease (CKD), which may abruptly increase cardiovascular disease (CVD) and its mortality rate compared with diabetes alone. Therefore, the modulation of the systemic inflammation may have the opportunity to improve both hyperglycemia and diabetic complications including vasculopathy and DKD.
Activated charcoal has been used clinically as a toxin absorbent. Some recent preclinical and clinical observations found the potential benefits and diverse effects of activated charcoal on inflammatory proteins, suggesting its potential immune modulation effects in CKD and related diseases. The current project is then designed to test the hypothesis that oral activated charcoal may be used as an anti-inflammatory strategy for diabetic complications especially DKD. We have recently demonstrated the renal protective effects of a new oral form of non-absorbable activated bamboo charcoal (ABC) in an animal model.
With OMICs studies, a growing preclinical and clinical evidence supports the theory that gut microbiome is a major contributor to adverse cardiovascular outcomes and progression of CKD, and the gut microbiota and its metabolites have the potential to be a novel therapeutic and preventative target for CKD. Additionally, current finding suggests that lncRNAs are involved in cardiovascular (CV) health and diseases. However, there is no report on the impact of gut microbiota on the host circulating lncRNA expression signature and the potential link between gut microbiota, circulating lncRNA levels changes and CKD. Although studies of probiotics which have benefits of CKD patients are numerous, few studies evaluated the effect of coadministration of activated charcoal/probiotics on the patients with CKD.
In this 12-month trial, 120 DKD subjects will be enrolled for each group (CKD group 1: CKD stage 3A; group 2: CKD stage 3B; group 3: CKD stage 4; and group 4: CKD stage 5). Each group of patients will be randomized into 6 subgroups A, B, C, D, E and F. Group A patients will receive ABC 2.3g three times a day in addition to standard care in the first 6 months, but group B patients will receive the same dosage of ABC in the last 6 months. Group C patients will receive probiotics 2g twice a day in addition to standard care in the first 6 months, but group D patients will receive the same dosage of probiotics in the last 6 months. Group E patients will receive ABC 2.3g three times a day and probiotics 2g twice a day in addition to standard care in the first 6 months, but group F patients will receive the same dosage of ABC and probiotics in the last 6 months. All patients will receive clinical assessments and examinations (gut microbiota, inflammatory proteins including CCL4, long-chain noncoding (lnc)RNAs, and uremic toxins) at baseline and every 3 months thereafter for 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| oral uremic toxin absorbent | Other | Dietary Supplement: oral uremic toxin absorbentBased on these previous findings, we will conduct a prospective randomized open blinded end-point (PROBE) study to see if oral uremic toxin absorbent + probiotics to modulate systemic inflammation and retard the progression of chronic kidney disease in patients with diabetes. |
| probiotics | Other | Dietary Supplement: probioticsBased on these previous findings, we will conduct a prospective randomized open blinded end-point (PROBE) study to see if oral uremic toxin absorbent + probiotics to modulate systemic inflammation and retard the progression of chronic kidney disease in patients with diabetes. |
| oral uremic toxin absorbent +/- probiotics | Experimental | Dietary Supplement: oral uremic toxin absorbent + probioticsDietary Supplement: Oral Uremic Toxin Absorbent/Probiotics This 12-month trial will enroll 120 subjects with Diabetic Kidney Disease (DKD), consisting of 60 subjects in CKD Stage 3A, 60 in Stage 3B, 60 in Stage 4, and 60 in Stage 5/dialysis. Each group will be randomized into six subgroups (A-F): Group A: Administered 2.3g of ABC three times daily during the latter 6 months. Group B: Administered 2g of probiotics twice daily during the latter 6 months. Group C: Administered a combination of oral uremic toxin absorbent/probiotics during the latter 6 months. Clinical evaluations and examinations will be performed at baseline and every 3 months over the 12-month duration, including gut microbiota, inflammatory proteins (e.g., CCL4), long non-coding RNA (lncRNA), and uremic toxins. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 20 years old but not pregnant on the day of screening.
- DKD patients with stable renal function (Cre elevation < 0.3 mg/dL for at least 30 days) and PCS level (fluctuation < 10% for at least 30 days)
- Group 1: 120 DKD patients with 45<eGFR<60 ml/min/1.73m2 in stable status. Group 2: 120 DKD patients with 30<eGFR<45 ml/min/1.73m2 in stable status. Group 3: 60 DKD patients with 15<eGFR<30 ml/min/1.73m2 in stable status Group 4: 60 DKD patients with eGFR<15 ml/min/1.73m2 in stable status
Key exclusion criteria (14 listed)
- Baseline eGFR > 90 ml/min/1.73m2 according to MDRD equation.
- Patients in severe malnutrition status, albumin less than 2.0 g/dL.
- Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin < 8 g/dL.
- Active peptic ulcer, esophageal varices, ileus or under fasting status
- Previous gastrointestinal operation.
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 |
|---|---|---|
| oral uremic toxin absorbentIn this 12-month trial, 300 DKD participants will be enrolled (60 with CKD stage 3A, 60 with stage 3B, 60 with stage 4, and 60 with stage 5 or on dialysis). Within each stage, participants will be randomized into three subgroups (A-C). Group A will receive ABC 2.3 g three times daily together with standard care during the last 6 months. Group B will receive probiotics 2 g twice daily during the last 6 months. Group C will receive both interventions during the last 6 months. Clinical assessments and examinations- including gut microbiota, inflammatory proteins (e.g., CCL4), long non-coding RNAs (lncRNAs), and uremic toxins- will be conducted at baseline and every 3 months for 12 months. | Dietary supplement | oral uremic toxin absorbent |
| probioticsIn this 12-month trial, 300 DKD participants will be enrolled (60 with CKD stage 3A, 60 with stage 3B, 60 with stage 4, and 60 with stage 5 or on dialysis). Within each stage, participants will be randomized into three subgroups (A-C). Group A will receive ABC 2.3 g three times daily together with standard care during the last 6 months. Group B will receive probiotics 2 g twice daily during the last 6 months. Group C will receive both interventions during the last 6 months. Clinical assessments and examinations- including gut microbiota, inflammatory proteins (e.g., CCL4), long non-coding RNAs (lncRNAs), and uremic toxins- will be conducted at baseline and every 3 months for 12 months. | Dietary supplement | probiotics |
| oral uremic toxin absorbent + probioticsIn this 12-month trial, 300 DKD participants will be enrolled (60 with CKD stage 3A, 60 with stage 3B, 60 with stage 4, and 60 with stage 5 or on dialysis). Within each stage, participants will be randomized into three subgroups (A-C). Group A will receive ABC 2.3 g three times daily together with standard care during the last 6 months. Group B will receive probiotics 2 g twice daily during the last 6 months. Group C will receive both interventions during the last 6 months. Clinical assessments and examinations- including gut microbiota, inflammatory proteins (e.g., CCL4), long non-coding RNAs (lncRNAs), and uremic toxins- will be conducted at baseline and every 3 months for 12 months. | Dietary supplement | oral uremic toxin absorbent +/- probiotics |
Primary outcome
The change of eGFR
Time frame: -6th month,-3th month,baseline,random, 3th month and 6th month
eGFR is estimated GFR calculated by the abbreviated MDRD equation : 186 x (Creatinine/88.4)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if black).
1 secondary outcome
The change of UACR
Time frame: baseline, 3th month and 6th month
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 15 Jan 2026.
- 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 study testing oral uremic toxin absorbent, probiotics and oral uremic toxin absorbent + probiotics in people with Oral Uremic Toxin Absorbent, run by National Taiwan University 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 3 inclusion and 14 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 15 Jan 2026. 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.
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 chauchung wu, PhD (886-2-23123456 ext. #288559, chauchungwu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of eGFR (time frame: -6th month,-3th month,baseline,random, 3th month and 6th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2026.