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NOT YET RECRUITING
NCT06614985
PHASE2

The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy

Sponsor: Renmin Hospital of Wuhan University

View on ClinicalTrials.gov

Summary

This is a multiple-center, prospective, open-label, positive drug controlled, randomized, clinical study to evaluate the safety and efficacy of Telitacicept in the treatment of primary membranous nephropathy.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

172

Start Date

2024-10-20

Completion Date

2027-10-01

Last Updated

2024-09-26

Healthy Volunteers

No

Interventions

DRUG

Telitacicept

Subcutaneous injection of 160 mg is administered once a week.

DRUG

Prednisone

Induction therapy period (3 months):Eligible subjects receive induction treatment with Methylprednisone 0.5 g i. v. for 3 consecutive day and followed by orally administration of prednisone at an initial dose of 0.8 mg/kg/day, tapered gradually after 2 months (reduced by 5 mg every 2 weeks) Grouped treatment period (6 months): The maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation.

DRUG

Cyclophosphamide

An intravenous injection of 0.4 g is administered twice a month.

Locations (1)

Renmin Hospital of Wuhan university

Wuhan, Hubei China, China