ClinicalTrials.gg
Not yet recruitingNCT07785739Updated Sep 2, 2026

Clinical Prediction Model for Disease Progression in Primary Membranous Nephropathy

An observational study in Membranous Nephropathy, Nephrotic Syndrome and Kidney Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
128
Ages
18 Years and older
Sex
All
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Study 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 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.

02

Conditions studied

  • Membranous Nephropathy
  • Nephrotic Syndrome
  • Kidney Diseases

Keywords

  • Primary membranous nephropathy
  • Prognostic nomogram
  • Disease progression
  • Renal outcomes
  • Anti-PLA2R
03

In context

Glomerulonephritis, Membranous

144 studies on the registry are indexed under Glomerulonephritis, Membranous; 58 are open to participants now.

This study's planned enrollment of 128 is close to the median of 120 across 35 observational studies indexed under Glomerulonephritis, Membranous.

Browse Glomerulonephritis, Membranous studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • -proven primary membranous nephropathy
  • Written

Exclusion criteria

Exclusion Criteria:

  • Secondary membranous nephropathy (e.g., lupus nephritis, or C, , drug-induced)
  • Pregnancy
  • End-stage kidney disease at presentation
  • Refusal to participate
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
128 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 months

Secondary outcomes

  1. 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

    Time frame: 6 months

  2. Decline in estimated glomerular filtration rate (eGFR)

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

    Time frame: 6 months

  3. Remission status

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

    Time frame: 6 month

  4. Validation of the prognostic nomogram

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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

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References and documents

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 40363910 ↗
  • Laurin 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 40630289 ↗
  • Ragy 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2026
First posted
Aug 25, 2026
StartEst.
Aug 20, 2026
Primary completionEst.
Aug 20, 2027
CompletionEst.
Mar 20, 2028
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07785739
Lead sponsor
Assiut University
Responsible party
Aisha ElQathafy Mahmoud (Resident, Assiut University) — Principal investigator
First posted
Aug 25, 2026
Start date
Aug 20, 2026 (estimated)
Primary completion
Aug 20, 2027 (estimated)
Completion
Mar 20, 2028 (estimated)
Last update
Sep 2, 2026

Study contacts

Aisha M Elqathafy, resident
Contact
aisha.18313210@med.aun.edu.eg
01148313428 ext. 022
Essam M Abdel Aziz, prof
study chair · Nephrology Unit, Internal Medicine Department, Assiut University Hospitals, Assiut, Egypt

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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