Kidney Week 2025 Annual Meeting-High-Impact Clinical Trials

Video Transcription

Video Summary

This recorded “high-impact clinical trial” session at ASN featured multiple kidney-disease trials and follow-up analyses.<br /><br />A Phase 2a double-blind trial tested cetinaxib (NOX1/4 inhibitor) added to ACE/ARB therapy in Alport syndrome (24 weeks). It was well tolerated, with one drug-related transient TSH rise and one unrelated serious event (cholecystitis). Proteinuria (UPCR) rose in both arms as expected, but increases were smaller with cetinaxib (mean ~15% lower vs placebo at 24 weeks; up to ~27% in ad hoc analyses). eGFR declined in both groups; interpretation was limited by small size and baseline imbalance.<br /><br />Stage A of a China-based Phase 3 IgA nephropathy trial showed telitacicept (dual BAFF/APRIL inhibitor) given weekly for 9 months reduced 24-hour UPCR by ~59% vs ~9% with placebo (placebo-adjusted ~55%), improved hematuria resolution, and stabilized eGFR; main adverse event was injection-site reactions.<br /><br />A regency trial biopsy substudy in lupus nephritis found obinutuzumab led to greater histologic remission (activity index ≤1 or 0) than placebo, including many “clinical non-responders,” and achieved deep intrarenal B-cell depletion with partial plasma-cell reduction—highlighting discordance between clinical and tissue response.<br /><br />A Phase 3 open-label China trial in primary membranous nephropathy found MIL-62 (glycoengineered type 2 anti-CD20) achieved far higher complete remission at week 76 (49% vs 4% with cyclosporine), rapid anti-PLA2R negativity, better eGFR preservation, and manageable infusion reactions.<br /><br />VISIONARY Phase 3 interim IgA nephropathy results for sibeprenlimab (APRIL inhibitor) showed ~51% placebo-adjusted UPCR reduction at 9 months and ~54% at 12 months, higher proteinuria remission and hematuria resolution, strong biomarker suppression (APRIL, Gd-IgA1), and placebo-like safety; eGFR slope will report later.<br /><br />Finally, MIRO-CKD Phase 2 tested balsamrenone (novel non-steroidal MRA) plus dapagliflozin vs dapagliflozin alone for 12 weeks, reducing UACR by ~23–33% vs placebo with modest, reversible potassium increases and reversible hemodynamic eGFR dip.

Asset Subtitle

Moderator(s): Laura Dember, Richard Haynes

Presentation(s):

Safety and Preliminary Efficacy Findings from a Phase 2A Randomized, Double-Blind, Placebo-Controlled Trial of Setanaxib in Patients with Alport Syndrome - Daniel Gale
Efficacy and Safety of Telitacicept in Patients with IgAN: Results from Stage A of a Phase 3 Clinical Study - Jicheng Lv
Beyond Clinical Response in the REGENCY Trial: The Impact of Obinutuzumab on Histologic Remission in Patients with Active Lupus Nephritis - Brad Rovin
Efficacy and Safety of MIL62, a Glycoengineered Type II Anti-CD20 Antibody, in Primary Membranous Nephropathy: A Phase 3, Randomized, Controlled Trial - Zhao Cui
Sibeprenlimab for the Treatment of IgAN: VISIONARY Phase 3 Interim and Prespecified Subgroup Analyses - Vlado Perkovic
Efficacy and Safety of Balcinrenone in Combination with Dapagliflozin on Albuminuria in Participants with CKD - Hiddo Heerspink

Note: Continuing education credits are not being offered for this session.

Meta Tag

Date 11/8/2025

Pathway 1 Other

Session ID 525618

Keywords

ASN high-impact clinical trials

Alport syndrome

cetinaxib NOX1/4 inhibitor

ACE inhibitor ARB background therapy

proteinuria UPCR reduction

IgA nephropathy

telitacicept BAFF APRIL inhibitor

sibeprenlimab APRIL inhibitor VISIONARY

lupus nephritis obinutuzumab biopsy substudy

intrarenal B-cell depletion histologic remission

primary membranous nephropathy MIL-62 anti-CD20

balsamrenone non-steroidal MRA MIRO-CKD dapagliflozin