Immune cell clues could unlock kidney disease treatment secrets
NCT ID NCT04095156
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is investigating why some people with membranous nephropathy, a kidney disease, respond well to a treatment that depletes certain immune cells (B-cells) while others do not. Researchers will analyze blood samples from 86 patients and healthy volunteers to compare immune cell types and activity. The goal is to find biological markers that predict treatment success and better understand the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this research could help doctors predict which patients will benefit from B-cell depleting therapy, leading to more personalized treatment for membranous nephropathy.
- What could go wrong
- This is an observational study, not a treatment trial. It aims to gather knowledge, not test a new therapy. Results may not directly change patient care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 86 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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 and healthy volunteers as controls
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centro di Ricerche Cliniche per le Malattie Rare " Aldo e Cele Daccò"
RECRUITINGRanica, BG, 24020, Italy
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Other studies related to the condition(s) this trial covers.
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- A new tool to predict kidney failure risk in membranous nephropathy?
- Can a smarter antibody outsmart a kidney disease that resists standard treatment?
- Can a single drug calm lupus kidney disease without a cocktail of meds?
- Immune cells may hold key to predicting kidney disease relapse