Open-Label Extension Study of BION-1301 in IgA Nephropathy

Status Recruiting

Clinical Trial Summary

This is an open-label extension (OLE) study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity of BION-1301 in adults with IgA nephropathy

Clinical Trial Description

This is a Phase 2, multicenter, open-label extension (OLE) study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody. Patients who previously participated in Study ADU-CL-19 (NCT03945318) will receive open-label treatment with BION-1301 for up to approximately 2 years. Study participants will receive BION-1301 at the same dose, route, and dosing schedule as they received in ADU-CL-19. Dose, route, and/or dosing schedule may be changed during the OLE study based on a review by the Safety Review Team of all available PK, PD, and clinical activity data from previous and ongoing studies of BION-1301. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04684745
Study type	Interventional
Source	Chinook Therapeutics, Inc.
Contact	Chinook Therapeutics
Phone	(206) 485-7051
Email	clinicaltrials@chinooktx.com
Status	Recruiting
Phase	Phase 2
Start date	September 10, 2020
Completion date	November 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05016323` - A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.	Phase 2
Withdrawn	`NCT02433236` - Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy	Phase 2
Recruiting	`NCT02231125` - Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy	Phase 4
Completed	`NCT01502579` - An Observational Study of IgA Nephropathy: Pathological Variants and Clinical Data	N/A
Not yet recruiting	`NCT01203007` - Diet Intervention in Food Sensitive Patients With IgA Nephropathy	N/A
Terminated	`NCT01129557` - Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease	Phase 4
Completed	`NCT00657059` - Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)	Phase 3
Completed	`NCT03719443` - First in Human Study to Assess Safety of VIS649 in Healthy Subjects	Phase 1
Withdrawn	`NCT02052219` - BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy	Phase 3
Completed	`NCT02112838` - Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy	Phase 2
Completed	`NCT00767221` - Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study	Phase 2
Recruiting	`NCT04438603` - The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy
Recruiting	`NCT06065852` - National Registry of Rare Kidney Diseases
Terminated	`NCT04905212` - A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy	Phase 2
Terminated	`NCT04042623` - Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy	Phase 2
Recruiting	`NCT03633864` - Fecal Microbiota Transplantation for Refractory IgA Nephropathy	Phase 2
Not yet recruiting	`NCT06454110` - Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)	Phase 2
Recruiting	`NCT02954419` - IgA Nephropathy Biomarkers Evaluation Study (INTEREST)
Recruiting	`NCT03001947` - IgA Nephropathy Registration Initiative of High Quality (INSIGHT)
Completed	`NCT01224028` - A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients	Phase 2