{"doi":"10.1016/j.ekir.2025.09.031","title":"Evaluating Sibeprenlimab in IgA Nephropathy - Rationale and Baseline Data from the VISIONARY Trial","abstract":"Introduction Immunoglobulin A (IgA) nephropathy is the most common primary glomerulonephritis and a leading cause of kidney failure worldwide. Treatments that target the underlying immune drivers of the disease to improve long-term patient outcomes are needed. Sibeprenlimab, a selective A Proliferation-Inducing Ligand (APRIL) inhibitor that significantly decreases pathogenic galactose-deficient IgA1 production and immune complex formation, is being investigated in the ongoing Phase 3 VISIONARY trial. Here, we summarize the overall study design and report on the baseline characteristics of patients enrolled in the trial. Methods VISIONARY is a multicenter, double-blind, placebo-controlled trial (ClinicalTrials.gov identifier, NCT05248646; study date of registration: 2022-02-18). Adults with biopsy-confirmed IgA nephropathy were randomized 1:1 to receive subcutaneous sibeprenlimab 400 mg or placebo once every 4 weeks for 26 doses. The primary endpoint is the 24-hour urine protein-to-creatinine ratio (uPCR-24h) at 9 months compared with the baseline. Results Of 510 enrolled patients across 31 countries, 58.8% were male, 59.0% were Asian, and 57.3% lived in East or South/Southeast Asia. The median age was 42.0 (range, 18.0-83.0) years; 97.8% of patients were using renin-angiotensin system inhibitors, and 45.1% were using sodium-glucose cotransporter 2 inhibitors. The mean (SD) baseline uPCR-24h was 1.54 (0.92) g/g. The mean (SD) baseline urine protein was 2.1 (1.3) g/day, and the mean (SD) baseline eGFR was 64.2 (25.3) mL/min/1.73 m 2 . Conclusion VISIONARY, the largest IgA nephropathy trial to date, is evaluating the efficacy and safety of subcutaneous sibeprenlimab in a broadly representative population with IgA nephropathy at high risk of disease progression.","journal":"Kidney International Reports","year":2025,"id":524564,"datarank":0.24141568686511508,"base_score":1.6094379124341003,"endowment":1.6094379124341003,"self_citation_contribution":0.24141568686511508,"citation_network_contribution":0.0,"self_endowment_contribution":0.24141568686511508,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":4,"citer_count":3,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9596,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT05248646"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":271627,"name":"Jonathan Barratt","orcid":"0000-0002-9063-7229","position":1,"is_corresponding":false},{"id":29431,"name":"Richard Lafayette","orcid":"0000-0003-3906-7934","position":2,"is_corresponding":false},{"id":236348,"name":"Adrian Liew","orcid":"0000-0002-0963-6270","position":3,"is_corresponding":false},{"id":614253,"name":"Yusuke Suzuki","orcid":"0000-0002-4077-9747","position":4,"is_corresponding":false},{"id":1398083,"name":"Kevin Carroll","orcid":"0000-0002-3500-9692","position":5,"is_corresponding":false},{"id":251771,"name":"Chee Kay Cheung","orcid":"0000-0001-8593-7625","position":6,"is_corresponding":false},{"id":90339,"name":"Vladimı́r Tesař","orcid":"0000-0001-6982-0689","position":7,"is_corresponding":false},{"id":286833,"name":"Hernán Trimarchi","orcid":null,"position":8,"is_corresponding":false},{"id":711451,"name":"Muh Geot Wong","orcid":"0000-0002-7575-9877","position":9,"is_corresponding":false},{"id":747329,"name":"Hong Zhang","orcid":"0000-0003-4037-7497","position":10,"is_corresponding":false},{"id":1398084,"name":"Jing Xia","orcid":"0009-0005-6602-8334","position":11,"is_corresponding":false},{"id":1398613,"name":"Cecile Fajardo","orcid":null,"position":12,"is_corresponding":false},{"id":902865,"name":"Lokesh Shah","orcid":"0000-0001-5452-3796","position":13,"is_corresponding":false},{"id":1398085,"name":"Jeffrey Hafkin","orcid":"0000-0002-6690-3240","position":14,"is_corresponding":false},{"id":240578,"name":"Dana V. Rizk","orcid":"0000-0002-6877-2811","position":15,"is_corresponding":false},{"id":75046,"name":"Vlado Perkovic","orcid":"0000-0002-4257-7620","position":0,"is_corresponding":true}],"reference_count":39,"raw_metadata":null,"created_at":"2026-07-19T02:50:12.083054Z","pmid":"41426046","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}