NCT04905212

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
DRUG	Telitacicept 160mg	Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.
DRUG	Telitacicept 240mg	Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.
DRUG	Placebo	Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.

Timeline

• Start date: 2021-11-04
• Primary completion: 2023-11-09
• Completion: 2023-11-09
• First posted: 2021-05-27
• Last updated: 2023-12-06

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study