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

NCT06924476 | Active Not Recruiting

• 1 other identifier: YXLL-KY-2025(064)
• Study Type: observational
• Target: 282
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Membranous Nephropathy

Keywords

Primary Membranous Nephropathy; Evaluation formula; Initiate immunosuppressive therapy

Outcome Measures

Primary Outcomes (1)

• Reasonably add immunosuppressive therapy

  Reasonably add immunosuppressive therapy, that is, refer to the risk stratification of PMN in the "KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases". Immunosuppressive therapy can be initiated for patients with moderate or higher risk; or for those whom the treating doctor deems to require immunosuppressive therapy due to severe and incurable nephrotic syndrome and its serious complications. Meeting either of the two conditions is sufficient.

  From enrollment to the reasonable addition of immunosuppressive agent treatme，no less than one weeknt

Study Arms (2)

Modeling Group

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

Verification group

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were registered in the Renal Disease Syndrome Multi-center Cohort Network (https://nsn.bjmu.edu.cn/index) and whose medical records were complete, and who met the PMN diagnostic criteria as stipulated in the KDIGO 2021 Clinical Practice Guidelines for the Management of Glomerular Diseases.

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Yipeng Liu: lead
• Peking University First Hospital: collaborator

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 250000, China

Location

Study Officials

• Yipeng Liu

  Qianfoshan Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 11, 2025
• Study Start: January 1, 1990
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)