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Status:

COMPLETED

Multitarget Therapy for Idiopathic Membranous Nephropathy

Lead Sponsor:

Beijing Friendship Hospital

Conditions:

Efficacy

Eligibility:

All Genders

18-70 years

Phase:

PHASE4

Brief Summary

Membranous nephropathy (MN) is one of the commonest causes of nephrotic syndrome in adults, idiopathic membranous nephropathy (IMN) accounts for 70%-80% of all MN patients. There is no standard specif...

Detailed Description

Membranous nephropathy (MN) is one of the commonest causes of nephrotic syndrome in adults, idiopathic membranous nephropathy (IMN) accounts for 70%-80% of all MN patients. There is no standard specif...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Age: 18-70 years.
  • Body weight: 50-90 kg.
  • Patients with membranous nephropathy were eligible if their diagnosis was confirmed by renal biopsy, with the biopsy sample examined by light, immunofluorescence, and electron microscopy. Renal biopsy samples were reviewed by the two principal investigators and two renal pathologists.
  • IMN patients with moderate risk and have a decline of less than 50% in proteinuria despite renin-angiotensin system blockade for at least 6 months before randomization. OR, IMN patients with high risk or very high risk.
  • Serum albumin \< 30 g/L.
  • eGFR by MDRD formula had to be ≥ 60 ml/min per 1.73 m2.
  • Exclusion criteria:
  • Secondary MN, pregnancy, breastfeeding, immunosuppressive treatment in the 3 preceding months, and active infectious disease.
  • Hepatitis B serology included Hbs antigen and Hbs and Hbc antibodies. Patients with active hepatitis B and those with past hepatitis B infection without anti-Hbs antibodies will be excluded.
  • Patients with reproductive demand will be excluded.

Exclusion

    Key Trial Info

    Start Date :

    June 9 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 3 2022

    Estimated Enrollment :

    82 Patients enrolled

    Trial Details

    Trial ID

    NCT04424862

    Start Date

    June 9 2020

    End Date

    February 3 2022

    Last Update

    February 17 2022

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, China, 100050

    2

    Beijing Frienship Hospital, Capital Medical University

    Beijing, Beijing Municipality, China, 100050