Different Immunosuppressive Treatment in iMN

Sponsor
Peking Union Medical College Hospital
Study ID
NCT04745728
Phase
PHASE3
Status
Recruiting
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Conditions

  • Idiopathic Membranous Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Prednisone — DRUG
    1mg/kg/d p.o.which will be tapered after 2 months and discontinued over a 6-12 month period.
  • Cyclophosphamide — DRUG
    1-2mg/kg/d p.o. with a target accumulated dose of 12g.
  • Rituximab — DRUG
    1000mg I.V. on D1 and at 6 month. After 6 month, in patients with response but not complete remission, Rituximab could be stopped or repeated with a 6 month-interval (12 month, 18 month, 24 month) until complete remission. Rituximab 1000mg I.V. will be repeated on the 15th day of each Rituximab infusion if CD19+ B cell count\>5/ul.

Study Details

The primary objective of this study is to compare the 24 month remission of different immunosuppressive therapies in the treatment of idiopathic membranous nephropathy (iMN)

Key Dates

Start date
Apr 14, 2021
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: cyclophosphamide and prednisone
    Prednisone will be given at 1mg/kg/d p.o. and will be tapered after 2 months and discontinued over a 6-12 month period. Cyclophosphamide will be given at 1-2mg/kg/d p.o. with a target accumulated dose of 12g. Azathioprine or mycophenolate mofetil are optional which could be given for a short period of time (\<6 months）after discontinuation of cyclophosphamide if patients do not remit at 6 month.
  • Active Comparator: Rituximab
    Rituximab 1000mg I.V. on Day1 and at 6 month. After 6 months, in patients with response but without complete remission, Rituximab could be stopped or repeated with a 6 month-interval (12 month, 18 month, 24 month) until complete remission. Rituximab 1000mg I.V. will be given on the 15th day after each Rituximab infusion if CD19+ B cell count\>5/ul on the 15th day. Calcineurin inhibitors (CNI) are optional but should be tapered after 6 months and discontinued after 9 months.

Primary Outcome Measure

complete or partial remission on 24 month [ Time Frame: 24 months ]

Central Contacts