NCT04291781

A Study of RC18 Administered Subcutaneously to Subjects With Primary IgA(Immunoglobulin A) Nephropathy

Phase II Clinical Trial of RC18(Recombinant Human B Lymphocyte Stimulator Receptor - Antibody Fusion Protein for Injection) in the Treatment of Primary IgA Nephropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of Tai Ai(Recombinant Human B Lymphocyte Stimulator Receptor-Antibody Fusion Protein for Injection) in the treatment of IgA nephropathy.

Detailed description

Both RC18 and Recombinant Human B Lymphocyte Stimulator Receptor-Antibody Fusion Protein for Injection are other names of Tai Ai. After a 35-day screen period, subjects are randomly allocated into 3 groups receiving subcutaneous injection of Tai Ai 160mg, Tai Ai 240mg, and placebo once a week individually. The treatment lasts 24 weeks. Subjects, the sponsor, investigators are blinded in the whole process of the trial.

Conditions

• Primary IgA Nephropathy

Interventions

Type	Name	Description
BIOLOGICAL	RC18 160mg	subcutaneous injection on the upper arm, abdomen, or upper thigh outside;
BIOLOGICAL	RC18 240mg	subcutaneous injection on the upper arm, abdomen, or upper thigh outside;
BIOLOGICAL	placebo	subcutaneous injection on the upper arm, abdomen, or upper thigh outside;

Timeline

• Start date: 2020-04-13
• Primary completion: 2021-05-20
• Completion: 2021-05-20
• First posted: 2020-03-02
• Last updated: 2024-09-19

Locations

1 site across 1 country: China