ALIGN
Trial question
What is the role of atrasentan in patients with IgA nephropathy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 270
270 patients (111 female, 159 male).
Inclusion criteria: adult patients with IgA nephropathy.
Key exclusion criteria: secondary IgA nephropathy; documented diagnosis of HF or previous hospitalization for HF; BNP level > 200 pg/mL.
Interventions
N=135 atrasentan (at a dose of 0.75 mg/day for 132 weeks).
N=135 placebo (matching placebo for 132 weeks).
Primary outcome
Mean reduction in urinary protein-to-creatinine ratio at week 36
38.1%
3.1%
38.1 %
28.6 %
19.1 %
9.5 %
0.0 %
Atrasentan
Placebo
Significant
increase ▲
NNT = 2
Significantly greater reduction in mean the urinary protein-to-creatinine ratio at week 36 (38.1% vs. 3.1%; MD 36.1, 95% CI 26.4 to 44.6).
Secondary outcomes
Significantly greater reduction in mean the urinary protein-to-creatinine ratio at week 36 in SGLT-2 inhibitor stratum (39.6% vs. 3.4%; MD 37.4, 95% CI 8.5 to 57.2).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In adult patients with IgA nephropathy, atrasentan was superior to placebo with respect to mean reduction in the urinary protein-to-creatinine ratio at week 36.
Reference
Hiddo J L Heerspink, Meg Jardine, Donald E Kohan et al. Atrasentan in Patients with IgA Nephropathy. N Engl J Med. 2024 Oct 25. Online ahead of print.
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