NCT05799287

A Study of Telitacicept for IgA Nephropathy (TELIGAN)

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Telitacicept in Patients With Primary IgA Nephropathy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy at risk of progressing to end-stage renal disease(ESRD), despite maximum tolerated treatment with renin-angiotensin system(RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

Detailed 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 subcutaneous injection（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.

Conditions

• Primary IgA Nephropathy

Interventions

Type	Name	Description
BIOLOGICAL	Telitacicept	Subcutaneous injection
DRUG	Placebo	Placebo to Telitacicept

Timeline

• Start date: 2023-04-28
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-04-05
• Last updated: 2025-12-16

Locations

101 sites across 1 country: China