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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Clinical Prediction Model for Disease Progression in Patients With Primary Membranous Nephropathy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07785739
- Acronym / sponsor ID
- pMN-Nomogram-2026
- Conditions
- Membranous Nephropathy, Nephrotic Syndrome, Kidney Diseases
- Keywords
- Primary membranous nephropathy, Prognostic nomogram, Disease progression, Renal outcomes, Anti-PLA2R
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Biopsy-proven primary membranous nephropathy
- Written informed consent
Key exclusion criteria (4 listed)
- Secondary membranous nephropathy (e.g., lupus nephritis, hepatitis B or C, malignancy, drug-induced)
- Pregnancy
- End-stage kidney disease at presentation
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
4 secondary outcomes
Independent clinical and laboratory predictors of disease progression
Time frame: 6 months
Decline in estimated glomerular filtration rate (eGFR)
Time frame: 6 months
Remission status
Time frame: 6 month
Validation of the prognostic nomogram
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 40363910Krakowska-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.
- Background: PubMed 40630289Laurin 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.
- Background: PubMed 39820570Ragy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Essam M Abdel Aziz, prof study chair
Nephrology Unit, Internal Medicine Department, Assiut University Hospitals, Assiut, Egypt
Questions about this trial
What is this clinical trial studying?
An observational study of Membranous Nephropathy and Nephrotic Syndrome, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aisha M Elqathafy, resident (01148313428 ext. 022, aisha.18313210@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the prognostic nomogram in predicting disease progression (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07785739, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.