Effects of Dapagliflozin on Progression of Alport Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-15

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients

NCT05944016

Chronic Kidney Failure in Children and Young Adults

RECRUITING PHASE3

Albuminuria Lowering Effect of Dapagliflozin, Spironolactone and Their Combination in Adult Patients with Alport Syndrome (COMBINE-ALPORT)

NCT06499948

Alport Syndrome Thin Basement Membrane Disease Alport Nephropathy

RECRUITING PHASE4

TreatIng Microalbuminuria Over 24 Weeks in Subjects With or Without Type 2 Diabetes or HYpertension

NCT05268926

Albuminuria

TERMINATED PHASE2

Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

NCT05753696

Proteinuria Kidney Dysfunction Blood Pressure +1 more

UNKNOWN NA

Effects of an Intensified Treatment With ACE-I,ATA II and Statins in Alport Syndrome

NCT00309257

Alport Syndrome

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alport Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dapagliflozin + RAS inhibitor

In addition to ACEI/ARB treatment, patients will receive dapagliflozin 10mg once daily for 24 months.

Dapagliflozin 10mg Tab

Intervention Type DRUG

Dapagliflozin 10mg daily plus RAS inhibitor

RAS inhibitor only

Patients will continue ACEI/ARB treatment for 24 months.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dapagliflozin 10mg Tab

Dapagliflozin 10mg daily plus RAS inhibitor

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dapagliflozin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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;

Exclusion Criteria

* 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;
* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No