TESTING 2
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
61.0% male
N = 503
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 m².
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
Composite outcome of sustained 40% decline in estimated glomerular filtration rate, kidney failure, or death due to kidney disease
28.8%
43.1%
43.1 %
32.3 %
21.6 %
10.8 %
0.0 %
Methylprednisolone
Placebo
Significant
decrease ▼
NNT = 6
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 m², 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.
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