Clinical Prediction Model for Disease Progression in Primary Membranous Nephropathy

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07785739

Enrollment

128

Registered

2026-08-25

Start date

2026-08-20

Completion date

2028-03-20

Last updated

2026-09-02

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

Conditions

Kidney Diseases, Membranous Nephropathy, Nephrotic Syndrome

Keywords

Primary membranous nephropathy, Prognostic nomogram, Disease progression, Renal outcomes, Anti-PLA2R

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Performance of the prognostic nomogram in predicting disease progression	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

Measure	Time frame	Description
Independent clinical and laboratory predictors of disease progression	6 months	Identification of independent clinical and laboratory predictors of disease progression in primary membranous nephropathy using multivariable analysis
Decline in estimated glomerular filtration rate (eGFR)	6 months	Change in estimated glomerular filtration rate (eGFR) from baseline, measured in mL/min/1.73 m².
Remission status	6 month	Proportion of patients achieving complete or partial remission according to KDIGO criteria
Validation of the prognostic nomogram	6 months	Validation of the predictive performance of the prognostic nomogram in the local patient population using discrimination and calibration metrics

Contacts

CONTACTAisha M Elqathafy, resident

aisha.18313210@med.aun.edu.eg01148313428

STUDY_CHAIREssam M Abdel Aziz, prof

Nephrology Unit, Internal Medicine Department, Assiut University Hospitals, Assiut, Egypt

Outcome results