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

NCT05532111 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-09-08

No results posted yet for this study

Summary

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

Conditions

  • Efficacy and Safety

Interventions

DRUG

Rituximab combined with tacrolimus induction + rituximab maintenance

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.

DRUG

Rituximab combined with tacrolimus induction + tacrolimus maintenance

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).

DRUG

Glucocorticoid combined with cyclophosphamide induction + maintenance

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.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-09-30
Completion
2024-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532111 on ClinicalTrials.gov