Status:

RECRUITING

Autoreactive B Cells in Membranous Nephropathy

Lead Sponsor:

Mario Negri Institute for Pharmacological Research

Conditions:

Membranous Nephropathy

Eligibility:

All Genders

18+ years

Brief Summary

Membranous nephropathy (MN) is the most frequent cause of nephrotic syndrome (NS) in adults. The majority of MN patients show detectable circulating antibodies against the M-type phospholipase A2 rece...

Eligibility Criteria

Inclusion

  • Patients inclusion criteria
  • Males and females.
  • Adults (\> 18 years old).
  • Patients with biopsy-proven idiopathic MN, who are candidate to receive (prospective cohort) or who already received (retrospective cohort) a B-cell depleting treatment as per center clinical practice.
  • Mental state is such that they are able to understand and give valid consent to the study;
  • Written informed consent according to the guidelines of the Declaration of Helsinki.
  • Healthy volunteers inclusion criteria
  • Male and female (\>18 years) not known to suffer of any significant illness;
  • Not assuming any medication or drug on a regular basis;
  • Negative urine analysis (urine dipstick, multistick);
  • Written informed consent according to the guidelines of the Declaration of Helsinki

Exclusion

  • Patients exclusion criteria
  • Reasonable possibility of a secondary cause of MN (e.g.systemic lupus erythematosus, active hepatitis B, malignancy, drugs such as gold salts and penicillamine).
  • Legal incapacity, intellectual disability/mental retardation, dementia, uncooperative attitude or any other evidence that patient will not be able to understand the study procedures and aims and to give written informed consent.
  • Healthy volunteers exclusion criteria
  • \- Legal incapacity, intellectual disability/mental retardation, dementia, uncooperative attitude or any other evidence that patient will not be able to understand the study procedures and aims and to give written informed consent.

Key Trial Info

Start Date :

September 12 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 1 2026

Estimated Enrollment :

86 Patients enrolled

Trial Details

Trial ID

NCT04095156

Start Date

September 12 2019

End Date

March 1 2026

Last Update

September 2 2025

Active Locations (1)

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

Ranica, BG, Italy, 24020