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A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy

IgA Nephropathy Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) With an Optional Open Label Extension in Subjects With IgA Nephropathy

Clinical Trial Summary

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.

Clinical Trial Description

IgA nephropathy is a kidney disease in which IgA, a protein meant to defend the body against foreign invaders, accumulates in the kidneys and damages them. This study will seek to determine the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy. The study is composed of 4 parts: a screening period, a double-blind treatment period, an optional open label extension, and a follow-up period. Subjects with confirmed IgA nephropathy will be enrolled and randomized 1:1:1 to Telitacicept 160 mg, Telitacicept 240 mg, or placebo (10 per arm). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04905212
Study type Interventional
Source RemeGen Co., Ltd.
Contact
Status Terminated
Phase Phase 2
Start date November 4, 2021
Completion date November 9, 2023
View Details
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