Table 2.
TRACTION-2 key inclusion criteria
Diagnosis | Inclusion criteria |
---|---|
All Patients |
Men or women (18 to 75 years of age, of any race) |
eGFR ≥30 mL/min/1.73 m2 at screening | |
Currently receiving an ACE inhibitor or ARB for at least the last 3 months before screening, with a stable dose for at least 4 weeks before screening (patients not receiving ACE inhibitors or ARBs because of allergy or intolerance to ACE inhibitors or ARBs are also eligible) | |
DN | Diagnosis of type 2 diabetes with HbA1c level ≤11% at screening |
Average UACR ≥150 to 5000 mg/g during screening and run-in visits | |
FSGS or TR-MCD | Diagnosis based on either biopsy, as documented by pathology report, or FSGS based on genetic testing |
TR-MCD defined as incomplete resolution of proteinuria, defined as persistent proteinuria (>1.0 g/24-h urine or >1.0 g/g UPCR) following at least 8 weeks of corticosteroids or another immunosuppressive therapy | |
Average UPCR ≥1.0 g/g during screening and run-in visits | |
Patients currently receiving corticosteroids or mycophenolate mofetil must have been receiving the medication for at least the last 3 months before screening, with a stable dose for at least 4 weeks before screening |
ACE, angiotensin converting enzyme; ARB, angiotensin receptor blocker; DN, diabetic nephropathy; eGFR, estimated glomerular filtration rate; FSGS, focal segmental glomerulosclerosis; TR-MCD, treatment-resistant minimal change disease; UACR, urinary albumin-to-creatinine ratio; UPCR, urinary protein-to-creatinine ratio.