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NCT Number: NCT06924476

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Primary Membranous Nephropathy

Sex eligibility

All sexes

Study type

Observational

Primary location

Qianfoshan Hospital

Jinan, Shandong, 250000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Reasonably add immunosuppressive therapy

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

    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.

Sponsors and collaborators

Lead sponsor

Yipeng Liu

Other

Collaborators

  • Peking University First Hospital

Registry information

Important dates

Study start
1990
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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