NCT06614985

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Renmin Hospital of Wuhan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consists of four stages as follows: 1. Screening period (0-6 months): After signing the informed consent form, subjects enter the screening period. 2. Induction treatment 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), and cyclophosphamide is administrated intravenously at a dose of 0.4 g/d twice a month. 3. Group treatment period (6 months): Patients who complete the induction treatment period undergo an efficacy assessment to determine whether they achieve a complete remission or partial remission. Patients who do not achieve a complete remission or partial remission are defined as non-responders. Patients who achieve a complete remission or partial remission are randomized and enter the group A or group B. Patients of non-responders are randomized and enter the group C and group D. Patients in group A and C continue the initial treatment regimen for 6 months. Patients in group B and D commence hypodermic injection of Telitacicept 160 mg weekly 6 months with the continued administration of prednisone and cyclophosphamide in group D while discontinued cyclophosphamide administration in group B. 4. Follow-up period (12 months): After completing 6 months of group treatment, cyclophosphamide or Telitacicept is discontinued with minimal dose of 5mg/d prednisone remained. All the patients are subjected to a 12-month follow-up.

Conditions

• Primary Membranous Nephropathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-20
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2024-09-26
• Last updated: 2024-09-26

Locations

1 site across 1 country: China