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NCT Number: NCT07785739

Clinical Prediction Model for Disease Progression in Primary Membranous Nephropathy

This prospective observational study aims to evaluate predictors of disease progression in patients with primary membranous nephropathy and to assess the performance of a prognostic nomogram in predicting renal outcomes in the Egyptian population.

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Key information

About this study

Primary membranous nephropathy (pMN) is a leading cause of nephrotic syndrome in adults. Its clinical course is highly variable, ranging from spontaneous remission to progressive kidney function decline and end-stage kidney disease. Current prognostic assessment relies mainly on conventional clinical and laboratory parameters such as proteinuria, serum creatinine, estimated glomerular filtration rate (eGFR), and serum albumin. These markers have limited accuracy in predicting individual patient outcomes.

Several prognostic nomograms have been developed by combining clinical, laboratory, and immunological variables. However, most of these models were derived from single-center cohorts and require external validation in different populations.

This prospective observational study will evaluate clinical and laboratory predictors of disease progression in patients with biopsy-proven primary membranous nephropathy and assess the performance of a prognostic nomogram for predicting renal outcomes in patients attending Assiut University Hospitals.

Who can participate

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

Inclusion criteria

  • Age ≥ 18 years
  • Biopsy-proven primary membranous nephropathy
  • Written informed consent

Exclusion criteria

  • Secondary membranous nephropathy (e.g., lupus nephritis, hepatitis B or C, malignancy, drug-induced)
  • Pregnancy
  • End-stage kidney disease at presentation
  • Refusal to participate

Treatment and study plan

Primary outcomes

  1. Performance of the prognostic nomogram in predicting disease progression

    Time frame: 6 months

    Ability of the prognostic nomogram to predict disease progression in patients with primary membranous nephropathy, assessed by the area under the receiver operating characteristic curve (AUC).

Secondary outcomes

  1. Independent clinical and laboratory predictors of disease progression

    Time frame: 6 months

    Identification of independent clinical and laboratory predictors of disease progression in primary membranous nephropathy using multivariable analysis

  2. Decline in estimated glomerular filtration rate (eGFR)

    Time frame: 6 months

    Change in estimated glomerular filtration rate (eGFR) from baseline, measured in mL/min/1.73 m².

  3. Remission status

    Time frame: 6 month

    Proportion of patients achieving complete or partial remission according to KDIGO criteria

  4. Validation of the prognostic nomogram

    Time frame: 6 months

    Validation of the predictive performance of the prognostic nomogram in the local patient population using discrimination and calibration metrics

Study contacts

Contact information is provided by the study sponsor or research team.

Aisha M Elqathafy, resident

CONTACT

[email protected]

01148313428 ext. 022

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Assessment of a Clinical Prediction Model for Disease Progression in Patients With Primary Membranous Nephropathy: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

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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