Membranous NephropathyNCT07785739
Clinical Prediction Model for Disease Progression in Primary Membranous Nephropathy
An observational study of Membranous Nephropathy and Nephrotic Syndrome, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Membranous Nephropathy, Nephrotic Syndrome, Kidney Diseases
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 20 Mar 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years
- Biopsy-proven primary membranous nephropathy
- Written informed consent
Who cannot join
- Secondary membranous nephropathy (e.g., lupus nephritis, hepatitis B or C, malignancy, drug-induced)
- Pregnancy
- End-stage kidney disease at presentation
- Refusal to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Membranous Nephropathy, Nephrotic Syndrome, Kidney Diseases
- Keywords
- Primary membranous nephropathy, Prognostic nomogram, Disease progression, Renal outcomes, Anti-PLA2R
- Medical subject headings
- Glomerulonephritis, Membranous, Nephrotic Syndrome, Kidney Diseases, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the prognostic nomogram in predicting disease progression
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).
Measured: 6 months
Secondary outcomes (4)
Independent clinical and laboratory predictors of disease progression
Identification of independent clinical and laboratory predictors of disease progression in primary membranous nephropathy using multivariable analysis
Measured: 6 months
Decline in estimated glomerular filtration rate (eGFR)
Change in estimated glomerular filtration rate (eGFR) from baseline, measured in mL/min/1.73 m².
Measured: 6 months
Remission status
Proportion of patients achieving complete or partial remission according to KDIGO criteria
Measured: 6 month
Validation of the prognostic nomogram
Validation of the predictive performance of the prognostic nomogram in the local patient population using discrimination and calibration metrics
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Aug 2027 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aisha ElQathafy Mahmoud, Assiut University
- Investigators
- Essam M Abdel Aziz, prof, Study chair, Nephrology Unit, Internal Medicine Department, Assiut University Hospitals, Assiut, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785739
- Sponsor's protocol ID
- pMN-Nomogram-2026
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Krakowska-Jura K, Kler AN, Wajerowska W, Konieczny A, Banasik M. Prognostic Factors of Proteinuria Remission in Primary Membranous Nephropathy. J Clin Med. 2025 Apr 22;14(9):2880. doi: 10.3390/jcm14092880.
PubMed 40363910Laurin LP, Helmuth M, Almaani S, Ayoub I, Chen DP, Villegas LA, Nast CC, Robinson BM, Derebail VK, Waldman M, Bomback AS; CureGN Consortium. Risk Factors for Disease Progression for Adults and Children With Membranous Nephropathy in the Cure Glomerulonephropathy Network (CureGN). Kidney Int Rep. 2025 Mar 24;10(6):1917-1928. doi: 10.1016/j.ekir.2025.03.027. eCollection 2025 Jun.
PubMed 40630289Ragy O, Abass W, Kanigicherla DAK, Shinkins B, Bestall J, King N, Brenchley P, Smith A, Hamilton P. PLA2R autoantibodies, a multifaceted biomarker in nephrotic syndrome and membranous nephropathy. Nephrol Dial Transplant. 2025 Aug 1;40(8):1458-1469. doi: 10.1093/ndt/gfaf012.
PubMed 39820570