drugset / Trial / NCT07098897

To Evaluate the Effect and Safety of Telitacicept and Standard Treatment for 6months in IgA Nephropathy

NCT07098897

Phase 3 Active not recruiting 150 enrolled The Affiliated Hospital of Xuzhou Medical University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with Telitacicept in patients with IgA nephropathy. The control group will be observed for up to 6months without administration of Telitacicept. This Single center, Randomized, Open Label, Comparative study will evaluate the effect and safety of and Standard treatment for 6months in IgA Nephropathy.

Timeline

Start
2024-08-01
Primary completion
2025-05-25
Completion
2025-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylprednisolone Other / unclassified 1 mg/kg
Comparator Prednisolone Other / unclassified 1 mg/kg
Subject Telitacicept Protein / enzyme biologic 160 mg Subcutaneous