An Outcome Analysis of Primary Membranous Nephropathy

NCT06242327 | Recruiting

• 1 other identifier: PROMENADE
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

This is an observational study intended to track the course of the primary membranous nephropathy disease in real-world clinical practice. The study will primarily assess the long-term outcomes of patients with primary membranous nephropathy in the context of advances in treatment options.

Conditions

Membranous Nephropathy

Keywords

Primary Membranous Nephropathy; Nephrotic Syndrome

Outcome Measures

Primary Outcomes (1)

• Evaluation of disease remission

  Combined endpoint of complete (proteinuria \< 0.3 g/24-hours) or partial (proteinuria \<3 g/24-hours with \>50% change vs proteinuria at baseline that is the time of the first rituximab or other monoclonal antibody administration) remission

  Through study completion, an average of 6 months

Secondary Outcomes (5)

• Evaluation of disease progression

  Through study completion, an average of 6 months

• Rate of GFR decline

  Through study completion, an average of 6 months

• Blood parameter levels

  Through study completion, an average of 6 months

• Incidence of adverse events

  Through study completion, an average of 6 months

• Incidence of drug related adverse events

  Through study completion, an average of 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enrol all patients with a diagnosis of primary membranous nephropathy and the nephrotic syndrome (proteinuria \>3.5 g/24-h) treated with rituximab or other monoclonal antibodies (including, among others, ofatumumab, obinutuzumab, felzartamab).

You may qualify if:

• Adults (≥18 years old) on the day of signing informed consent.
• Diagnosis of primary membranous nephropathy
• Nephrotic syndrome (proteinuria \>3.5 g/24 hours)
• Written informed consent to the use of recorded data for research purposes.

You may not qualify if:

• Legal incapacity or limited legal capacity.
• Any contraindication to treatment with rituximab or other monoclonal antibody

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (2)

ASST HPG23 - Unità di Nefrologia

Bergamo, BG, 24127, Italy

ACTIVE NOT RECRUITING

Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò"

Ranica, BG, 24020, Italy

RECRUITING

Related Publications (6)

• Schieppati A, Mosconi L, Perna A, Mecca G, Bertani T, Garattini S, Remuzzi G. Prognosis of untreated patients with idiopathic membranous nephropathy. N Engl J Med. 1993 Jul 8;329(2):85-9. doi: 10.1056/NEJM199307083290203.

  PMID: 8510707 BACKGROUND

• Remuzzi G, Chiurchiu C, Abbate M, Brusegan V, Bontempelli M, Ruggenenti P. Rituximab for idiopathic membranous nephropathy. Lancet. 2002 Sep 21;360(9337):923-4. doi: 10.1016/S0140-6736(02)11042-7.

  PMID: 12354476 BACKGROUND

• Ruggenenti P, Cravedi P, Chianca A, Perna A, Ruggiero B, Gaspari F, Rambaldi A, Marasa M, Remuzzi G. Rituximab in idiopathic membranous nephropathy. J Am Soc Nephrol. 2012 Aug;23(8):1416-25. doi: 10.1681/ASN.2012020181. Epub 2012 Jul 19.

  PMID: 22822077 BACKGROUND

• Ruggenenti P, Debiec H, Ruggiero B, Chianca A, Pelle T, Gaspari F, Suardi F, Gagliardini E, Orisio S, Benigni A, Ronco P, Remuzzi G. Anti-Phospholipase A2 Receptor Antibody Titer Predicts Post-Rituximab Outcome of Membranous Nephropathy. J Am Soc Nephrol. 2015 Oct;26(10):2545-58. doi: 10.1681/ASN.2014070640. Epub 2015 Mar 24.

  PMID: 25804280 BACKGROUND

• Ruggenenti P, Fervenza FC, Remuzzi G. Treatment of membranous nephropathy: time for a paradigm shift. Nat Rev Nephrol. 2017 Sep;13(9):563-579. doi: 10.1038/nrneph.2017.92. Epub 2017 Jul 3.

  PMID: 28669992 BACKGROUND

• Perna A, Ruggiero B, Podesta MA, Perico L, Orisio S, Debiec H, Remuzzi G, Ruggenenti P. Sexual dimorphic response to rituximab treatment: A longitudinal observational study in a large cohort of patients with primary membranous nephropathy and persistent nephrotic syndrome. Front Pharmacol. 2022 Sep 2;13:958136. doi: 10.3389/fphar.2022.958136. eCollection 2022.

  PMID: 36120314 BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis, Membranous; Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Nephrosis

Study Officials

• Giuseppe Remuzzi, MD

  Istituto Di Ricerche Farmacologiche Mario Negri

  STUDY DIRECTOR

Central Study Contacts

Matias Trillini, MD

CONTACT

+3903545351; matias.trillini@marionegri.it

Piero L Ruggenenti, MD

CONTACT

pruggenenti@asst-pg23.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 5, 2024
• Study Start: November 29, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2054
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)