Alport Syndrome
Conditions
Interventions
Experimental group:basic treatment (angiotensin-converting enzyme inhibitors, ACEIs, or angiotensin receptor blockers, ARBs) combined with dapagliflozin
Sponsors
Guangzhou Women and Children’s Medical Center, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age greater than 3 years old and less than 18 years old; 2. Meet the diagnostic criteria for Alport syndrome in China's "Guidelines for the Diagnosis and Treatment of Rare Diseases (2019 Edition)"; 3. Urinary protein/creatinine>0.5mg/mg; 4. Calculate and estimate glomeruli based on Schwartz formula [K x height (cm)/creatinine (µ mol/L)] Estimated glomerular filtration rate (eGFR) >= 60 ml/min/1.73m2; 5. Use ACEI or ARB drugs for more than 4 weeks with stable dosage; 6. Signed a dated written informed consent form before the start of the experiment.
Exclusion criteria
Exclusion criteria: 1. Received immunosuppressive therapy within the past 3 months; 2. Patients with type 1 or type 2 diabetes, other types of kidney diseases or malformations of urinary system development; 3. Rapid decline in renal function level within the past month (eGFR decreased by more than 25% within one month) or occurrence of acute kidney injury; 4. Those who have serious infectious diseases and have not been controlled; 5. Uncontrolled hypertension (blood pressure greater than 145/95mmHg during screening); Blood pressure lower than P5 in children of the same gender, age, and height; 6. Coexistence with other serious and/or unstable diseases, such as severe cardiovascular disease, respiratory disease, liver disease, or neurological and psychiatric disorders; 7. History of previous organ transplantation and/or tumor and/or gastrointestinal surgery; 8. Merge other medical conditions that may affect drug absorption, distribution, metabolism, and excretion; 9. Have used other types of sodium glucose cotransporter 2 inhibitors within the month prior to enrollment, or have been previously allergic to such drugs; 10. Patients who are currently participating in clinical trials of other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of decrease in urinary protein/creatinine; | — |
Secondary
| Measure | Time frame |
|---|---|
| serum creatinine;cystatin C;abnormal urine red blood cell count;uric acid;urea nitrogen;eGFR decreasing slope; | — |
Countries
China
Contacts
Public ContactXia Gao
Guangzhou Women and Children’s Medical Center, Guangzhou Medical University
Outcome results
None listed