6/30/23, 2:16 AM TESTING 2 Pathway Feedback Search Clinical Topics Home Studies TESTING 2 TESTING 2 Disease Immunoglobulin A nephropathy Trial question What is the role of methylprednisolone in patients with IgA nephropathy? Study design Multi-center Double blinded RCT Population Characteristics of study participants 39.0% female N = 503 61.0% male 503 patients (198 female, 305 male) Inclusion criteria: patients with IgA nephropathy, proteinuria of 1 g/day and an eGFR of 20-120 mL/min/1.73 m Key exclusion criteria: strong indication or contraindication for corticosteroid therapy; active infection; systemic immunosuppressive therapy in the previous year; uncontrolled hypertension; unstable kidney function for other reasons Interventions N=257 methylprednisolone (an oral incremental course for 6-9 months followed by weaning) N=246 placebo (matching oral placebo) Primary outcome https://web.pathway.md/studies/recpGqOotx9SswVa4 1/2 6/30/23, 2:16 AM TESTING 2 Pathway Composite outcome of sustained 40% decline in estimated glomerular filtration rate, kidney failure, or death due to kidney disease 43.1 % 43.1 32.3 % 28.8 21.6 % Significant decrease 10.8 % NNT = 7 0.0 % Methylprednisolone Placebo Significant decrease in composite outcome of sustained 40% decline in eGFR, kidney failure, or death due to kidney disease (28.8% vs. 43.1%; HR 0.53, 95% CI 0.39 to 0.72) Secondary outcomes Significant decrease in kidney failure (19.5% vs. 27.2%; HR 0.59, 95% CI 0.4 to 0.87) Safety outcomes Significant difference in serious adverse events (10.9% vs. 2.8%). Conclusion In patients with IgA nephropathy, proteinuria of 1 g/day and an eGFR of 20-120 mL/min/1.73 m , methylprednisolone was superior to placebo with respect to the composite outcome of sustained 40% decline in eGFR, kidney failure, or death due to kidney disease. Reference Jicheng Lv, Muh Geot Wong, Michelle A Hladunewich et al. Effect of Oral Methylprednisolone on Decline in Kidney Function or Kidney Failure in Patients With IgA Nephropathy: The TESTING Randomized Clinical Trial. JAMA. 2022 May 17;327(19):1888-1898. Open reference URL https://web.pathway.md/studies/recpGqOotx9SswVa4 2/2