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

Sponsor
Renmin Hospital of Wuhan University
Study ID
NCT06614985
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Primary Membranous Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept — DRUG
    Subcutaneous injection of 160 mg is administered once a week.
  • Prednisone — DRUG
    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.
  • Cyclophosphamide — DRUG
    An intravenous injection of 0.4 g is administered twice a month.

Study Details

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 Dates

Start date
Oct 20, 2024
Status verified
Sep 2024
Primary completion
Oct 1, 2026
Completion
Oct 1, 2027

Study Design

Enrollment
172 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A
    After completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Patients who have achieved complete or partial remission are then randomly assigned to either Group A or Group B at a 1:1 ratio. Medication regimen of Group A： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Cyclophosphamide injection：an intravenous injection of 0.4 g is administered twice a month.
  • Experimental: Group B
    Medication regimen of Group B： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Telitacicept injection：an intravenous injection of 0.4 g is administered twice a month.
  • Active Comparator: Group C
    After completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Non-responders are randomly assigned to either Group C or Group D at a 1:1 ratio. Medication regimen of Group C： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Cyclophosphamide injection：an intravenous injection of 0.4 g is administered twice a month.
  • Experimental: Group D
    Medication regimen of Group D： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Telitacicept injection：an intravenous injection of 0.4 g is administered twice a month.

Primary Outcome Measure

Complete remission rate at the end of follow-up (21 months post-treatment) [ Time Frame: 21 months ]

Central Contacts

Related Studies