Hope for rare kidney disease: drug trial targets protein leak
NCT ID NCT06295770
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether obinutuzumab, a drug used for certain blood cancers, can help people with fibrillary glomerulonephritis (FGN), a rare kidney condition that causes protein leakage and can lead to kidney failure. Twenty adults with confirmed FGN will receive the drug intravenously twice in the first month and again at six months. Researchers will measure changes in protein levels in urine over a year to see if the drug improves kidney health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- obinutuzumab (Gazyva)
- What this could lead to
- If it works, this could point toward a treatment for fibrillary glomerulonephritis, a rare kidney disease, by reducing protein leakage and preserving kidney function.
- What could go wrong
- This is a small, early-phase trial with only 20 people, so results may not apply broadly. The drug may cause side effects like infections or infusion reactions, and it's not yet proven to be effective.
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.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Dec 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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: * ≥18 years of age * Biopsy proven fibrillary glomerulonephritis * Proteinuria \> 1.0 g/24hrs prior to initiation of immunosuppressive therapy * eGFR ≥ 20 ml/min/BSA Exclusion Criteria: * Secondary FGN (due to monoclonal gammopathy, autoimmune disease or malignancy) * Presence of a secondary pathology on biopsy (e.g. diabetic nephropathy) * Hepatitis B, C or HIV positive * Pregnant or breast-feeding * Active infection * Kidney transplant * Anemia with Hgb \< 8.0 g/dL * Thrombocytopenia with platelet count \< 100'000 * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication * Patients who have received cyclophosphamide in the last 6 months * Patients who have received ACTH and/or mycophenolate mofetil in the last 30 days * Patient who are on prednisone therapy at a dose \> 10 mg/day in the last 15 days * Patients who received rituximab previously with CD20 count of \< 5 cells/microliter at the time of enrollment * For women who are not postmenopausal (greater than or equal to \[\>/=\] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug * For men: agreement to remain abstinent or use two adequate methods for contraception, including at least one method with failure rate of less than 1% per year during the treatment period and for at least 6 months (180 days) after the last dose of drug
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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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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States