Table 3.
TRACTION-2 key exclusion criteria
| Diagnosis | Exclusion criteria |
|---|---|
| All Patients |
Evidence of another kidney disease clinically or on biopsy |
| Uncontrolled BP (systolic BP >160 mm Hg or diastolic BP >90 mm Hg) | |
| BMI >45 kg/m2 for DN patients; >40 kg/m2 for FSGS/TR-MCD patients | |
| ALT and/or AST >2 × ULN at screening or a known history of severe or chronic hepatobiliary disease | |
| Women who are pregnant or are breastfeeding | |
| Positive HIV test result or hepatitis B or C infection | |
| Clinically significant cardiovascular disease | |
| History of kidney transplantation | |
| DN | Current or past renal disease that requires immunosuppressive therapy |
| FSGS or TR-MCD | Currently receiving CNI therapy or history of CNI resistance |
| Systemic immunosuppressive or corticosteroid therapy for non−kidney disease indications | |
| Received rituximab or cyclophosphamide within 120 days of screening | |
| Received plasmapheresis within 84 days of screening | |
| Biopsy consistent with collapsing FSGS |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMI, body mass index; BP, blood pressure; CNI, calcineurin inhibitor; DN, diabetic nephropathy; FSGS, focal segmental glomerulosclerosis; HIV, human immunodeficiency virus; TR-MCD, treatment-resistant minimal change disease; ULN, upper limit of normal.