Optimization of a Decision Formula for Optimal Timing of Immunosuppressive Therapy Initiation in Primary Membranous Nephropathy: A Multicenter Retrospective Cohort Study

NCT ID: NCT06924476

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

282 participants

Study Classification

OBSERVATIONAL

Study Start Date

1990-01-01

Study Completion Date

2025-09-30

Brief Summary

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The goal of this observational study is to optimize the evaluation formula for the timing of initiating immunosuppressive therapy in primary membranous nephropathy in patients with primary membranous nephropathy. The main question it aims to answer is:When should immunosuppressive therapy be initiated?This study is a retrospective one. Participants will not receive any treatment.

Detailed Description

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Conditions

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Primary Membranous Nephropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Modeling Group

The data of this group of participants are used to construct the evaluation formula.

No interventions assigned to this group

Verification group

The data of this group of participants are used to verify the evaluation formula constructed through the modeling group.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* It meets one of the diagnostic criteria for PMN as stipulated in the KDIGO 2021 Clinical Practice Guidelines for the Management of Glomerular Diseases: patients with a clear diagnosis of PMN based on renal biopsy pathology or presenting with nephrotic syndrome and positive anti-PLA2R antibody detection (\>14RU/mL), and excluding secondary factors such as tumors, infections, drugs, and systemic autoimmune diseases.

Exclusion Criteria

* (1) Patients who have received treatment with immunosuppressive medications other than oral prednisolone.

(2) The time interval between the renal biopsy and the baseline measurement is longer than 3 years.

(3) Initiate the use of immunosuppressive agents within 1 week after the diagnosis of PMN.

(4) Participate in the immunosuppressive treatment trial during the follow-up period and be in the intervention group.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role collaborator

Yipeng Liu

OTHER

Sponsor Role lead

Responsible Party

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Yipeng Liu

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yipeng Liu

Role: STUDY_CHAIR

Qianfoshan Hospital

Locations

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Qianfoshan Hospital

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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YXLL-KY-2025(064)

Identifier Type: -

Identifier Source: org_study_id

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