Clinical Prediction Model for Disease Progression in Primary Membranous Nephropathy

September 1, 2026 updated by: Aisha ElQathafy Mahmoud, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Aisha M Elqathafy, resident
Phone Number: 022 01148313428
Email: aisha.18313210@med.aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adults with biopsy-proven primary membranous nephropathy attending the Nephrology Unit, Department of Internal Medicine, Assiut University Hospitals who meet the eligibility criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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.	6 months
Remission status Time Frame: 6 month	Proportion of patients achieving complete or partial remission according to KDIGO criteria	6 month
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	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

Study Chair: Essam M Abdel Aziz, prof, Nephrology Unit, Internal Medicine Department, Assiut University Hospitals, Assiut, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

August 20, 2027

Study Completion (Estimated)

March 20, 2028

Study Registration Dates

First Submitted