Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy.


Clinical Trial Description

This study consists of a 5-week screening period, a double-blind treatment period divided into phase A and phase B. Eligible subjects will be randomly assigned in a 1:1 ratio to receive either Telitacicept 240mg or placebo. Subjects will be given SC Telitacicept or placebo once a week for a total of 39 doses in phase A and once every 2 weeks for a total of 32 doses in phase B. Primary endpoint of phase A will be measured at week 39. Primary endpoint of phase B will be measured at week 104. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05799287
Study type Interventional
Source RemeGen Co., Ltd.
Contact Binghua Xiao
Phone 86-101-58076833
Email binghua.xiao@remegen.com
Status Recruiting
Phase Phase 3
Start date April 28, 2023
Completion date December 2025

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Withdrawn NCT02433236 - Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy Phase 2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
Recruiting NCT04684745 - Open-Label Extension Study of BION-1301 in IgA Nephropathy Phase 2
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Withdrawn NCT02052219 - BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy Phase 3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
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