CompletedNot Applicable

B Cells in Idiopathic Nephrotic Syndrome

Italy21 participantsStarted 2019-04-02

Plain-language summary

The main aim of the present study is to determine whether reconstitution of different B-cell subpopulations can predict relapse after treatment with B-cell depleting antibodies in adult with NS, and whether specific B- or T-cell anomalies (as well as dysregulation of other circulating immune cell subsets) may play a role in the disease pathogenesis of SDNS and FRNS.

Who can participate

Age range6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female children (≥6 and \<18 years old) and adults.
✓. Patients with biopsy-proven MCD or FSGS or MesGN candidate to (prospective cohort) or treated with (retrospective cohort) anti-CD20 monoclonal antibodies (when possible) due to INS and fulfilling the following conditions:
✓. For adults: written informed consent according to the guidelines of the Declaration of Helsinki.
✓. For children: written informed consent (according to the guidelines of the Declaration of Helsinki) of parent(s) or guardian.

Exclusion criteria

✕. Reasonable possibility of a secondary cause of NS: active hepatitis B or C infection, or other chronic systemic infections; malignancy; drug abuse.
✕. 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.

What they're measuring

Differences between NS patients who relapse (R) or who achieved sustained remission (NR) after B-cell depleting monoclonal antibody treatment in frequency of circulating B cell subpopulations

Timeframe: At baseline, 6,9 12 and 24 months after treatment.

Differences between NS patients who relapse (R) or who achieved sustained remission (NR) after B-cell depleting monoclonal antibody treatment in frequency of circulating T cell

Timeframe: At baseline, 6,9 12 and 24 months after treatment.

Differences between NS patients who relapse (R) or who achieved sustained remission (NR) after B-cell depleting monoclonal antibody treatment in NK-cell

Timeframe: At baseline, 6,9 12 and 24 months after treatment.

Differences between NS patients who relapse (R) or who achieved sustained remission (NR) after B-cell depleting monoclonal antibody treatment in monocyte

Timeframe: At baseline, 6,9 12 and 24 months after treatment.

Differences between NS patients who relapse (R) or who achieved sustained remission (NR) after B-cell depleting monoclonal antibody treatment in dendritic cell subpopulations

Timeframe: At baseline, 6,9 12 and 24 months after treatment.

Differences between NS patients who relapse (R) or who achieved sustained remission (NR) after B-cell depleting monoclonal antibody treatment in serum levels of cytokines

Timeframe: At baseline, 6,9 12 and 24 months after treatment.

Trial details

NCT IDNCT05712369

SponsorMario Negri Institute for Pharmacological Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-07

View on ClinicalTrials.gov More Nephrotic Syndrome trials

Plain-language summary

Who can participate

Age range6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female children (≥6 and \<18 years old) and adults.
✓. Patients with biopsy-proven MCD or FSGS or MesGN candidate to (prospective cohort) or treated with (retrospective cohort) anti-CD20 monoclonal antibodies (when possible) due to INS and fulfilling the following conditions:
✓. For adults: written informed consent according to the guidelines of the Declaration of Helsinki.
✓. For children: written informed consent (according to the guidelines of the Declaration of Helsinki) of parent(s) or guardian.

Exclusion criteria

✕. Reasonable possibility of a secondary cause of NS: active hepatitis B or C infection, or other chronic systemic infections; malignancy; drug abuse.
✕. 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.