Efficacy and Safety of the Treatment of Primary Membranous Nephropathy: A Randomized Clinical Trial

Sponsor
RenJi Hospital
Study ID
NCT05532111
Status
Unknown

Conditions

  • Efficacy and Safety

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab combined with tacrolimus induction + rituximab maintenance — DRUG
    RT-R group: Rituximab 1 g/time, once in 15 days, × 2 times, combined with tacrolimus, the initial dose is 0.05-0.1 mg/kg/d, 2 times at an interval of 12 hours, orally. Adjust the dose according to the blood concentration (maintain the blood concentration C0 4-8ng/ml). At the end of 24 weeks, tacrolimus was stopped, and rituximab was given 1 g/time × 1 time.
  • Rituximab combined with tacrolimus induction + tacrolimus maintenance — DRUG
    RT-T group: Rituximab 1 g/time, once in 15 days, × 2 times, combined with tacrolimus, the initial dose is 0.05-0.1 mg/kg/d, 2 times at an interval of 12 hours, orally. Adjust the dose according to the blood concentration (maintain the blood concentration C0 4-8ng/ml).
  • Glucocorticoid combined with cyclophosphamide induction + maintenance — DRUG
    PC-C group: The initial dose of prednisone/prednisolone was 0.5-1 mg/kg/d (the maximum dose was 70 mg/d), and the dose was gradually reduced after 4-8 weeks, and then stopped within 6-9 months. Cyclophosphamide 750mg/m2 (adjusted according to eGFR and other conditions), once a month, intravenous pulse therapy. CTX maintenance therapy.

Study Details

1. Main purpose: To evaluate the efficacy and safety of rituximab combined with tacrolimus in the treatment of intermediate and high-risk primary membranous nephropathy 2. Secondary research purposes: To describe the survival of patients with intermediate and high-risk primary membranous nephropathy treated with rituximab combined with tacrolimus; To describe renal survival in patients with intermediate and high-risk primary membranous nephropathy treated with rituximab combined with tacrolimus; 3. Exploratory research purposes: Feasibility of glucocorticoids-free therapy (rituximab combined with tacrolimus) in the treatment of intermediate and high-risk primary membranous nephropathy

Key Dates

Start date
Sep 1, 2022
Status verified
Sep 2022
Primary completion
Sep 30, 2023
Completion
Sep 30, 2024

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RT-R Group
    Rituximab combined with tacrolimus induction + rituximab maintenance
  • Experimental: RT-T Group
    Rituximab combined with tacrolimus induction + tacrolimus maintenance
  • Experimental: PC-C Group
    Glucocorticoid combined with cyclophosphamide induction + maintenance

Primary Outcome Measure

24-hour urine protein quantification [ Time Frame: 48 weeks ]

Central Contacts