Alport SyndromeNCT06226896
Effects of Dapagliflozin on Progression of Alport Syndrome
An observational study of Alport Syndrome, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
Recently, a series of large clinical trials have confirmed the cardio-renal protective effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors. but few patients with hereditary nephritis were included in these studies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alport Syndrome
- What is being tested?
- Dapagliflozin 10mg Tab
- How many people
- 222 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2023to 30 Sep 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Alport syndrome who are at risk for kidney disease progression
Who may be able to join
- Histologic or genetic confirmation of Alport syndrome;
- eGFR ≥ 30 ml/min/1.72m2;
- Proteinuria > 0.5 g/24 h;
- Use of an ACE inhibitor or ARB, dose stable for more than 4 weeks;
Who cannot join
- Concurrence of other types of kidney disease;
- type 1 or type 2 diabetes;
- use of other types of sodium-glucose cotransporter 2 inhibitors within the month prior to enrollment, or prior allergy to such drugs;
- ACEI combined with ARB, or direct renin inhibitors, aldosterone receptor antagonists;
- Uncontrolled hypertension (blood pressure greater than 160/90 mmHg during screening);
- Patients undergoing renal transplantation or maintenance dialysis treatment;
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- Coexist with other serious and/or unstable diseases, such as serious cardiovascular diseases, respiratory diseases, liver diseases or neuropsychiatric diseases;
- Patients who are participating in clinical trials of other drugs;
- Pregnant or lactating women, or patients who do not want to receive contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Recently, a series of large clinical trials have confirmed the cardio-renal protective effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors. but few patients with hereditary nephritis were included in these studies. This study is to evaluate the effects of dapagliflozin on slowing kidney disease progression in patients with Alport syndrome.
- Conditions
- Alport Syndrome
- Being tested
- Dapagliflozin 10mg Tab
- Medical subject headings
- Nephritis, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Also called Dapagliflozin
Dapagliflozin 10mg daily plus RAS inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin + RAS inhibitor | In addition to ACEI/ARB treatment, patients will receive dapagliflozin 10mg once daily for 24 months. Receives: Drug: Dapagliflozin 10mg Tab | |
| RAS inhibitor only | Patients will continue ACEI/ARB treatment for 24 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of eGFR
The change of eGFR from baseline after 24 months of treatment
Measured: 24 months
Secondary outcomes (2)
Change of proteinuria
The change of proteinuria from baseline after 24 months of treatment
Measured: 24 months
Progression of kidney disease
The incidence of doubling of serum creatinine, a sustained ≥40% eGFR decline from baseline, or end-stage kidney disease after treatment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start15 Nov 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alport SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-Hong Liu, MD, Nanjing University School of Medicine
- Investigators
- Yu An, MD, Principal investigator, National Clinical Research Center of Kidney Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226896
- Sponsor's protocol ID
- 2023DZKY-094
- Status last verified
- Sep 2024
- First submitted
- 16 Jan 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dapagliflozin on Progression of Alport Syndrome
- ClinicalTrials.gov ID
- NCT06226896
- Acronym / sponsor ID
- 2023DZKY-094
- Conditions
- Alport Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Jan 2024 (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.
Recently, a series of large clinical trials have confirmed the cardio-renal protective effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors. but few patients with hereditary nephritis were included in these studies. This study is to evaluate the effects of dapagliflozin on slowing kidney disease progression in patients with Alport syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin + RAS inhibitor | – | Drug: Dapagliflozin 10mg TabIn addition to ACEI/ARB treatment, patients will receive dapagliflozin 10mg once daily for 24 months. |
| RAS inhibitor only | – | –Patients will continue ACEI/ARB treatment for 24 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Alport syndrome who are at risk for kidney disease progression
Key inclusion criteria (4 listed)
- Histologic or genetic confirmation of Alport syndrome;
- eGFR ≥ 30 ml/min/1.72m2;
- Proteinuria > 0.5 g/24 h;
- Use of an ACE inhibitor or ARB, dose stable for more than 4 weeks;
Key exclusion criteria (9 listed)
- Concurrence of other types of kidney disease;
- type 1 or type 2 diabetes;
- use of other types of sodium-glucose cotransporter 2 inhibitors within the month prior to enrollment, or prior allergy to such drugs;
- ACEI combined with ARB, or direct renin inhibitors, aldosterone receptor antagonists;
- Uncontrolled hypertension (blood pressure greater than 160/90 mmHg during screening);
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 |
|---|---|---|
| Dapagliflozin 10mg TabAlso: DapagliflozinDapagliflozin 10mg daily plus RAS inhibitor | Drug | Dapagliflozin + RAS inhibitor |
Primary outcome
Change of eGFR
Time frame: 24 months
The change of eGFR from baseline after 24 months of treatment
2 secondary outcomes
Change of proteinuria
Time frame: 24 months
Progression of kidney disease
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Yu An, MD principal investigator
National Clinical Research Center of Kidney Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alport Syndrome, run by Nanjing University School of Medicine at 1 site in China.
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 9 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 5 Sep 2024. 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 China. 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?
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?
Change of eGFR (time frame: 24 months). 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 5 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.