Roche Presents Positive Phase III Kidney Drug Data
New study results show the injectable drug sefaxersen significantly reduces protein in the urine for patients with IgA nephropathy.
Updated on Oct. 23, 2026 in Diabetes
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Roche shared phase III clinical trial data for sefaxersen, a monthly injectable treatment that reduced proteinuria by 43.1% compared to a placebo in patients with IgA nephropathy. The study results were presented at ASN Kidney Week to demonstrate the drug's potential in slowing disease progression.
Why it matters
IgA nephropathy affects millions of adults worldwide and leads to end-stage kidney disease in up to 50% of patients within 20 years, making effective new treatments critical for long-term health outcomes. By inhibiting complement factor B in the liver, sefaxersen aims to reduce inflammation to protect kidney function.
The IMAgINATION study enrolled 459 participants randomized 1:1, reporting a 43.1% reduction in proteinuria at 37 weeks. IgA nephropathy affects at least 25 adults per million annually, with half of patients facing end-stage kidney failure within 20 years.
The players
Roche
This Switzerland-based multinational healthcare company specializes in pharmaceuticals and diagnostics.
The details
Sefaxersen is a once-monthly subcutaneous injection designed for self-administration, which showed no new safety signals in the study. Patients with baseline haematuria also experienced higher rates of haematuria resolution at the 37-week mark.
Timeline
October 23, 2026: Roche presented phase III study data at ASN Kidney Week.
37 weeks: The duration for measuring the primary endpoint of proteinuria reduction.
105 weeks: The scheduled end of the blinded study evaluation period.
The Big Picture
This story marks a potential shift in the management of IgA nephropathy by providing new clinical data from the IMAgINATION study. The findings build on existing therapeutic strategies for rare kidney diseases by utilizing complement inhibition to target the disease at its source.
For those with IgA nephropathy, this data suggests a future option for once-monthly self-administered injections to help preserve kidney function. Patients should discuss the clinical progress of this drug with their nephrologist to understand potential long-term treatment implications.
The takeaway
Sefaxersen represents a targeted approach to managing inflammatory kidney disease through monthly self-administration. Patients and families managing progressive renal conditions should monitor upcoming regulatory filings for information regarding eventual treatment availability.
What happens next
The IMAgINATION study will continue through the 105-week mark to evaluate changes in estimated glomerular filtration rate, with Roche planning to submit data to health authorities thereafter.
Further reading
Learn more about the latest developments in chronic condition management in our Diabetes section.
More information
View the IMAgINATION study trial registry details for comprehensive participant criteria.
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