NCT05136456

Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy

A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR1459 Tablets in the Treatment of Primary Membranous Nephropathy (PMN)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Reistone Biopharma Company Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.

Detailed description

This study is a phase II study to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.

Conditions

• Primary Membranous Nephropathy

Interventions

Type	Name	Description
DRUG	SHR1459 Low Dose	SHR1459 oral tablets taken once daily (QD) for 24weeks
DRUG	SHR1459 High Dose	SHR1459 oral tablets taken once daily (QD) for 24 weeks
DRUG	Placebo	Placebo oral tablets taken once daily (QD) for 24 weeks

Timeline

• Start date: 2021-12-15
• Primary completion: 2023-08-28
• Completion: 2024-03-11
• First posted: 2021-11-29
• Last updated: 2023-09-05

Locations

19 sites across 1 country: China