Diabetic NephropathiesNCT06031389
Henagliflozin Delays the Progress of Diabetic Nephropathy Via Regulates Gut-Renal Axis
A study testing Henagliflozin in people with Diabetic Nephropathies, run by Qianfoshan Hospital.
Trial summary
Diabetic kidney disease (DKD) is a serious complication of diabetes, and it is also the leading cause of end-stage renal disease (ESRD) in the world. The aggravation of progressive proteinuria and the decrease of glomerular filtration rate are the important reasons for the development of DKD into ESRD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Henagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18-65 years old, regardless of gender; 2. It was confirmed as DKD by renal biopsy. 3. It needs to be treated with DKD standard scheme, but it can be adjusted according to needs.
- 4.eGFR>30ml/min/1.73m2 5.200mg/g<UACR<5000mg/g 6. Stabilize the maximum tolerated dose ACEi/ARB ≥4 weeks. 7. Volunteer to participate in the study, understand the significance of this experiment and the indicators to be measured, and sign the informed consent form.
Who cannot join
- 1. Severe infection: there are clinical manifestations such as fever, cough and expectoration, sore throat, abdominal pain, diarrhea, carbuncle and furuncle, and the white blood cell count in blood is beyond the normal range (10× 109/L); 2. Severe hypoproteinemia (albumin < 20g/L) 3 malnutrition or BMI<18.5 kg/m2. 4. Hemoglobin < 60g/L; 5. No full capacity; 6. Severe hypotension (< 90/60mmhg); 7. Severe hypertension (> 180/110mmHg). Have used SGLT2i of any kind, dosage and dosage form within 8.6 months or are intolerant of such drugs.
- 9.1 type diabetes mellitus 10. Patients who have had ketoacidosis, diabetic coma or multiple hypoglycemia episodes in the past.
- 11. Polycystic kidney disease, lupus nephritis, ANCA- related vasculitis. 12. Immunosuppressant treatment for 6 months or less before enrollment. 13. Severe heart failure (NYHA grade ≧II-III) 14. Other serious heart diseases, such as recent myocardial infarction, persistent atrial fibrillation and valvular heart disease.
- 15 patients with severe liver dysfunction (ALT or AST>3 times the normal upper limit, or total bilirubin > 2 times the normal upper limit) 16. Chronic cystitis, or urinary tract infection ≥3 times within 1 year. 17 patients with obvious bleeding tendency or blood system diseases, or patients with bone marrow suppression.
- 18. Malignant tumor 19. Pregnant women, lactating patients or patients who plan to become pregnant. 20. There are acute or severe systemic infections. 21. The subject is participating in clinical trials of other drugs or medical devices.
- 22. Any known drug or alcohol dependence, difficulty in understanding the trial protocol, and inability or unwillingness to follow up according to the trial protocol.
- 23. Moderate and severe cognitive impairment and no long-term fixed guardian. 24. Chronic diarrhea and indigestion 25. Patients that the researcher thinks are not suitable to participate in this trial.
About this study
Diabetic kidney disease (DKD) is a serious complication of diabetes, and it is also the leading cause of end-stage renal disease (ESRD) in the world. The aggravation of progressive proteinuria and the decrease of glomerular filtration rate are the important reasons for the development of DKD into ESRD. It is an important task in the medical field to delay the development of DKD into ESRD. In recent years, gut microbiota disorder has been considered as an important influencing factor of DKD, and the concept of gut-renal axis has attracted more and more attention. The disorder of gut microbiota in DKD patients is mainly manifested by the decrease in the abundance of probiotics such as Lactobacillus, Bifidobacterium and Akkermansia, which produce short-chain fatty acids (SCFA), and the increase in the abundance of uremic toxin-producing bacteria such as Ruminococcus, Alistipes and Subdoligranulum. Improving gut microbiota disorder and increasing the concentration of beneficial metabolites such as SCFA in serum have positive effects on improving DKD. In recent years, with the application of sodium-glucose cotransporter 2 inhibitors (SGLT-2i), diabetes has been effectively treated. SGLT-2i can reduce blood glucose concentration by inhibiting renal tubular glucose reabsorption, and at the same time, it can play a renal protection role independent of blood glucose reduction by correcting the unbalanced tubuloglomerular feedback during diabetes and improving inflammation. However, the mechanism of its renal protection seems to be more than that. Studies have shown that SGLT-2i can reduce proteinuria in DKD mice by regulating the disordered gut microbiota during DKD, but not all SGLT-2i preparations have the effect of protecting target organs by regulating gut microbiota. Wang found that canagliflozin can regulate the gut microbiota of diabetes mice and improve cardiovascular complications; Lee reported that dapagliflozin could reduce the ratio of Firmicutes/Bacteroides in DKD mice and increase the abundance of Akkermansia. Yang found that dapagliflozin increased the abundance of Proteobacteria in diabetes rats, but it did not seem to affect the ratio of Firmicutes/Bacteroides. Van Bommel reported that dapagliflozin would not affect the gut microbiot of diabetes patients. Whether henagliflozin can improve DKD by regulating the gut-renal axis is worthy of further study.
- Conditions
- Diabetic Nephropathies
- Being tested
- Henagliflozin, Placebo
- Keywords
- Henagliflozin, Diabetic Nephropathy, enteric microorganisms
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HenagliflozinDrug
On the basis of hypoglycemic therapy, the patients in the intervention group were given the drug treatment of hengglinide, once a day, 10mg or 5mg each time, taken in the morning, for 12 months.
PlaceboDrug
On the basis of basic treatment, patients in the blank control group were given starch tablets once a day, 10mg or 5mg each time, taken in the morning for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Henagliflozin | Experimental | On the basis of basic treatment, the patients in the Hengglinide（tabuletta） intervention group were given Hengglinide once a day, 10mg or 5mg each time in the morning, and continued to intervene for 12 months. Receives: Drug: Henagliflozin |
| Placebo | Placebo comparator | The blank control group was treated with placebo (starch tablets) once a day, 10mg or 5mg each time, taken in the morning for 12 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of intestinal flora difference between intervention group and control group with diabetic nephropathy by bacterial 16srDNA sequencing
16srDNA sequencing was used to detect the difference of relative abundance of different kinds of intestinal flora between the two groups.
Measured: baseline、1 month、3 month、6 month and 12 month
Secondary outcomes (1)
Statistical analysis of the degree of proteinuria relief in intervention group and control group.
T-test or Wilcoxon rank-sum test were used to compare the difference of urinary microalbumin creatinine ratio in two groups of diabetic nephropathy patients in regular urine biochemical tests.
Measured: baseline、1 month、3 month、6 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zunsong Wang, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031389
- Sponsor's protocol ID
- HENA-DKD
- Status last verified
- Sep 2023
- First submitted
- 29 Jul 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Henagliflozin Delays the Progress of Diabetic Nephropathy Via Regulates Gut-Renal Axis
- ClinicalTrials.gov ID
- NCT06031389
- Acronym / sponsor ID
- HENA-DKD
- Conditions
- Diabetic Nephropathies
- Keywords
- Henagliflozin, Diabetic Nephropathy, enteric microorganisms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Sep 2023 (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.
Diabetic kidney disease (DKD) is a serious complication of diabetes, and it is also the leading cause of end-stage renal disease (ESRD) in the world. The aggravation of progressive proteinuria and the decrease of glomerular filtration rate are the important reasons for the development of DKD into ESRD. It is an important task in the medical field to delay the development of DKD into ESRD. In recent years, gut microbiota disorder has been considered as an important influencing factor of DKD, and the concept of gut-renal axis has attracted more and more attention. The disorder of gut microbiota in DKD patients is mainly manifested by the decrease in the abundance of probiotics such as Lactobacillus, Bifidobacterium and Akkermansia, which produce short-chain fatty acids (SCFA), and the increase in the abundance of uremic toxin-producing bacteria such as Ruminococcus, Alistipes and Subdoligranulum. Improving gut microbiota disorder and increasing the concentration of beneficial metabolites such as SCFA in serum have positive effects on improving DKD. In recent years, with the application of sodium-glucose cotransporter 2 inhibitors (SGLT-2i), diabetes has been effectively treated. SGLT-2i can reduce blood glucose concentration by inhibiting renal tubular glucose reabsorption, and at the same time, it can play a renal protection role independent of blood glucose reduction by correcting the unbalanced tubuloglomerular feedback during diabetes and improving inflammation. However, the mechanism of its renal protection seems to be more than that. Studies have shown that SGLT-2i can reduce proteinuria in DKD mice by regulating the disordered gut microbiota during DKD, but not all SGLT-2i preparations have the effect of protecting target organs by regulating gut microbiota. Wang found that canagliflozin can regulate the gut microbiota of diabetes mice and improve cardiovascular complications; Lee reported that dapagliflozin could reduce the ratio of Firmicutes/Bacteroides in DKD mice and increase the abundance of Akkermansia. Yang found that dapagliflozin increased the abundance of Proteobacteria in diabetes rats, but it did not seem to affect the ratio of Firmicutes/Bacteroides. Van Bommel reported that dapagliflozin would not affect the gut microbiot of diabetes patients. Whether henagliflozin can improve DKD by regulating the gut-renal axis is worthy of further study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Henagliflozin | Experimental | Drug: HenagliflozinOn the basis of basic treatment, the patients in the Hengglinide（tabuletta） intervention group were given Hengglinide once a day, 10mg or 5mg each time in the morning, and continued to intervene for 12 months. |
| Placebo | Placebo comparator | Drug: PlaceboThe blank control group was treated with placebo (starch tablets) once a day, 10mg or 5mg each time, taken in the morning for 12 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1.18-65 years old, regardless of gender; 2. It was confirmed as DKD by renal biopsy. 3. It needs to be treated with DKD standard scheme, but it can be adjusted according to needs.
- 4.eGFR>30ml/min/1.73m2 5.200mg/g<UACR<5000mg/g 6. Stabilize the maximum tolerated dose ACEi/ARB ≥4 weeks. 7. Volunteer to participate in the study, understand the significance of this experiment and the indicators to be measured, and sign the informed consent form.
Key exclusion criteria (7 listed)
- 1. Severe infection: there are clinical manifestations such as fever, cough and expectoration, sore throat, abdominal pain, diarrhea, carbuncle and furuncle, and the white blood cell count in blood is beyond the normal range (10× 109/L); 2. Severe hypoproteinemia (albumin < 20g/L) 3 malnutrition or BMI<18.5 kg/m2. 4. Hemoglobin < 60g/L; 5. No full capacity; 6. Severe hypotension (< 90/60mmhg); 7. Severe hypertension (> 180/110mmHg). Have used SGLT2i of any kind, dosage and dosage form within 8.6 months or are intolerant of such drugs.
- 9.1 type diabetes mellitus 10. Patients who have had ketoacidosis, diabetic coma or multiple hypoglycemia episodes in the past.
- 11. Polycystic kidney disease, lupus nephritis, ANCA- related vasculitis. 12. Immunosuppressant treatment for 6 months or less before enrollment. 13. Severe heart failure (NYHA grade ≧II-III) 14. Other serious heart diseases, such as recent myocardial infarction, persistent atrial fibrillation and valvular heart disease.
- 15 patients with severe liver dysfunction (ALT or AST>3 times the normal upper limit, or total bilirubin > 2 times the normal upper limit) 16. Chronic cystitis, or urinary tract infection ≥3 times within 1 year. 17 patients with obvious bleeding tendency or blood system diseases, or patients with bone marrow suppression.
- 18. Malignant tumor 19. Pregnant women, lactating patients or patients who plan to become pregnant. 20. There are acute or severe systemic infections. 21. The subject is participating in clinical trials of other drugs or medical devices.
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 |
|---|---|---|
| HenagliflozinOn the basis of hypoglycemic therapy, the patients in the intervention group were given the drug treatment of hengglinide, once a day, 10mg or 5mg each time, taken in the morning, for 12 months. | Drug | Henagliflozin |
| PlaceboOn the basis of basic treatment, patients in the blank control group were given starch tablets once a day, 10mg or 5mg each time, taken in the morning for 12 months. | Drug | Placebo |
Primary outcome
Detection of intestinal flora difference between intervention group and control group with diabetic nephropathy by bacterial 16srDNA sequencing
Time frame: baseline、1 month、3 month、6 month and 12 month
16srDNA sequencing was used to detect the difference of relative abundance of different kinds of intestinal flora between the two groups.
1 secondary outcome
Statistical analysis of the degree of proteinuria relief in intervention group and control group.
Time frame: baseline、1 month、3 month、6 month and 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Henagliflozin in people with Diabetic Nephropathies, run by Qianfoshan Hospital.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of intestinal flora difference between intervention group and control group with diabetic nephropathy by bacterial 16srDNA sequencing (time frame: baseline、1 month、3 month、6 month and 12 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 11 Sep 2023.