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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06924476

Enrollment

282

Registered

2025-04-11

Start date

1990-01-01

Completion date

2025-09-30

Last updated

2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Membranous Nephropathy

Keywords

Primary Membranous Nephropathy, Evaluation formula, Initiate immunosuppressive therapy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Reasonably add immunosuppressive therapy	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.

Countries

China

Outcome results