Nefecon Shows Promise in IgAN Kidney Function Advancement
Table of Contents
A subanalysis of the phase 3 NeflgArd study reveals that nefecon, a targeted-release formulation of budesonide, significantly improves kidney function in patients with immunoglobulin A nephropathy (IgAN), regardless of thier initial kidney function.
New research indicates that Nefecon, an oral medication designed to release the drug in the distal ileum, has shown notable benefits in slowing the decline of kidney function in individuals diagnosed with IgAN. The findings come from a subanalysis of the phase 3 NeflgArd study.
study Design
The neflgard study involved randomly assigning patients with primary IgAN into two groups of 182 individuals each. one group received 16 mg of Nefecon daily, while the other received a placebo, both in conjunction with supportive care using renin-angiotensin system inhibition. Following this, there was a 15-month observation period without the drug, but with continued supportive care.
“This NefIgArd subanalysis demonstrated that the efficacy of a 9-month Nefecon treatment course…was self-reliant of baseline eGFR,”
For the subanalysis,patients were further categorized based on their estimated glomerular filtration rate (eGFR) deciles relative to the study population. The eGFR levels were stratified above and below 38, 43, 47, 51, 55, 60, 66, 72, and 82 mL/min/1.73 m2.
The median eGFR across all participants was 55.49 mL/min/1.73 m2, and this was consistent between the Nefecon and placebo groups.
Key Findings
The study revealed that the relative benefit of Nefecon on eGFR was evident across most deciles and timepoints.A greater benefit was generally observed in groups with higher baseline eGFR (above 72 mL/min/1.73 m2).
Furthermore, a relative improvement in the urine protein-creatinine ratio was seen from month 9 with Nefecon compared to placebo, irrespective of baseline eGFR. This reduction continued to month 12, with the treatment benefit maintained up to month 24.
The eGFR benefits with Nefecon over placebo were observed in patients within both the upper and lower deciles over the 2-year period.
eGFR showed a clear benefit during treatment and a delayed decline during the observation period.
Expert Perspective
“This NefIgArd subanalysis demonstrated that the efficacy of a 9-month Nefecon treatment course in reduction of proteinuria and preservation of kidney function was independant of baseline eGFR,” said first author Jonathan Barratt, MD, of the College of Life Sciences, University of Leicester, UK.
“So, we should be confident about treating people with Nefecon across the full range of eGFR in terms of the eGFR saving we’re going to see, but also the proteinuria reduction,” he added.
Sources
