IgA Nephropathy
Conditions
Interventions
group 1:"ambrisentan"-"henagliflozin"-"ambrisentan+henagliflozin"
group 2:"ambrisentan"-"ambrisentan+henagliflozin"-"henagliflozin"
group 3:"henagliflozin"-"ambrisentan"-"ambrisentan+henagliflozin"
group 4:"henagliflozin"-"ambrisentan+henagliflozin"-"ambrisentan"
group 5:"ambrisentan+henagliflozin"-"henagliflozin"-"ambrisentan"
group 6:"ambrisentan+henagliflozin"-"ambrisentan"-"henagliflozin"
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age = 18 years; 2.Biopsy-proven primary IgA nephropathy; 3.On a stable dose of renin-angiotensin-aldosterone system (RAAS) inhibitors for at least 4 weeks prior to randomization, with stable well-controlled blood pressure according to guidelines of KDIGO for IgAN management ( 30 mL/min/1.73m2 based on the CKD-EPI equation; 5.Persistent proteinuria (urinary protein: creatinine ratio =0.75 g/g or 24-hour total urine protein =1 g/24 h in two consecutive measurements over = 2 weeks); 6.Willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1.Secondary IgA nephropathy (e.g. due to Henoch-Schonlein purpura, psoriasis, Ankylosing Spondylitis, liver cirrhosis) or complicated by other autoimmune diseases; 2.Known medical history or clinical evidence suggesting non-IgAN renal disease (e.g. Type 1 or 2 diabetes, lupus nephritis, Autosomal dominant or autosomal recessive polycystic kidney disease). 3.Other causes of unstable kidney function, such as acute kidney injury due to excessive hematuria (past events should not be excluded); 4.Previous treatment with systemic immunosuppressant medications (e.g. prednisone, cyclosporin, tacrolimus, mycophenolate mofetil, tripterygium wilfordii) in the past 3 months; However, exceptions are made in the following situation: Use of prednisolone =0.5 mg/kg for non-kidney disease (e.g. allergies and asthma caused by other reasons) for no more than 2 weeks; 5.Indication for immunosuppressive therapy with corticosteroids, such as: 1). IgAN Patients with rapidly progressive glomerulonephritis (RPGN) or nephrotic syndrome (NS), 2). Cellular/fibrocellular crescents present in >50% of glomeruli on a renal biopsy within the last 12 months. 6. Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 4 weeks prior to the screening visit and during study intervention treatment. Participant currently treated with ambrisentan, or other endothelin receptor antagonists (ERAs) (e.g. Bosentan, Atrasentan) or a renin inhibitor or who received ambrisentan, or other ERAs or a renin inhibitor which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment; 7. Patient has a documented history of diabetes mellitus; 8. Patients with known allergies or intolerance to any component of Henagliflozin or Ambrisentan, rare congenital galactose intolerance, lactase deficiency, or glucose-galactose malabsorption; 9. BMI40kg/m2; 10. SBP>180mmHg or SBP2x the upper limit of normal [ULN]; or total bilirubin >2x ULN at screening; 17.For women, pregnancy, breast feeding, or intent to become pregnant during the study, and at least 1 month afterward; 18.For men, intent to father a child or donate sperm during the study, and at least 3 months afterward; 19.Current Urinary tract infections; 20
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary protein-to-creatinine ratio (UPCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour urine total protein (24-hUTP);Estimated glomerular filtration rate (eGFR) ;Systolic blood pressure; | — |
Countries
China
Contacts
Public ContactJicheng Lv
Peking University First Hospital
Outcome results
None listed