IgA nephropathy
Conditions
Interventions
Dapagliflozin treatment group:Dapagliflozin tablets 10mg once daily for 24 weeks + RAAS inhibitor at the maximum tolerable dose
Control group:RAAS inhibitor at the maximum tolerable dose
Sponsors
Daping Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participate voluntarily and sign informed consent; 2. No gender limit, aged >=18 years; 3. The subject's renal puncture biopsy was pathologically confirmed as IgA nephropathy; 4. 24 hours urinary protein quantitative 0.3 ~ 3.5g/d; 5. Serum albumin >30g/L; 6. Estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73 m^2 (calculated eGFR using CKD-EPI equation); 7. Ability to follow research or follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Patients who have recently planned to have a baby, are pregnant or are breastfeeding; 2. Failure to understand the potential risks and benefits of the study and to follow up and evaluate as required; 3. No capacity for civil conduct; 4. History of drug or alcohol abuse; 5. Acute genitourinary infection; 6. Patients with other autoimmune diseases, connective tissue diseases, amyloidosis and those requiring immunosuppressive therapy; 7. Renal biopsy pathology showed crescent body >25%; 8. Secondary IgA nephropathy; 9. Any more complex medical problems that may interfere with research practices or lead to increased risk, such as malignancies, hematological diseases, heart diseases, liver diseases, AIDS, viral hepatitis, etc.; 10. Patients who have participated in other drug clinical trials or are participating in other clinical trials within 1 month prior to participating in this trial; 11. Used immunosuppressant within 3 months; 12. Receiving SGLT2i treatment within 2 weeks or having prior intolerance to SGLT2i; 13. Patients with type 1 diabetes or diabetic ketoacidosis; 14. Allergic reaction to dagliazine or excipients; 15. Hemodynamic instability (mean arterial pressure <65mmHg, or any manifestations of organ underperfusion, such as oliguria or cold extremities).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour urinary protein quantification;Rate of change of urinary protein;Urinary microalbumin/urinary creatinine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum creatinine;Estimate glomerular filtration rate (eGFR);Urine sediment red blood cell count;Incidence of adverse events;Glycosylated hemoglobin; | — |
Countries
China
Contacts
Public ContactDai Huanzi
Daping Hospital, Army Medical University
Outcome results
None listed