Fibrillary GlomerulonephritisPhase 2NCT06295770
Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
A Phase 2 study testing Obinutuzumab in people with Fibrillary Glomerulonephritis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrillary Glomerulonephritis
- What is being tested?
- Obinutuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Biopsy proven fibrillary glomerulonephritis
- Proteinuria > 1.0 g/24hrs prior to initiation of immunosuppressive therapy
- eGFR ≥ 20 ml/min/BSA
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Nicholas Geroux, 507-266-0956, geroux.nicholas@mayo.edu
Corbyn Bendtsen, 507-284-0366, bendtsen.corbyn@mayo.edu
About this study
Official title: A Single-Center Phase 2 Open-Label Trial Evaluating the Efficacy and Safety of Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).
- Conditions
- Fibrillary Glomerulonephritis
- Being tested
- Obinutuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
Also called Gazyva
Obinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6.
| Study group | Role | What they receive |
|---|---|---|
| Obinutuzumab in Treatment of Fibrillary Glomerulonephritis | Experimental | Patients with biopsy proven fibrillary GN who have >1 gram/24 hour of proteinuria and eGFR ≥ 20 ml/min/BSA will be treated with Obinutuzumab. Receives: Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab
Measured using 24-hour urine collection reported in mg/24h
Measured: Baseline, 6 months, 12 months
Secondary outcomes (5)
Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab
Measured using 24-hour urine collection reported in mg/24h
Measured: Baseline, 6 months
Rate of complete or partial remission
Complete remission: Proteinuria < 0.5g/24 hrs. and no more than 20% decline in eGFR Partial remission: 50% reduction in proteinuria and proteinuria < 3.5 g/24hrs and no more than 20% decline in eGFR
Measured: 6 months, 12 months
Improvement in serum albumin
Blood serum collected and reported in g/dL
Measured: Baseline, 6 months, 12 months
Stabilization of kidney function
Stabilization is defined as no more than 20% decline in eGFR at 6 months and 12 months. Blood serum collected and reported in mL/min/BSA.
Measured: Baseline, 6 months, 12 months
Serious Adverse Events (SAEs)
Rate of all Serious Adverse Events (SAEs) including serious infection defined as severe UTI or pyelonephritis, pneumonias or other systemic infections requiring hospitalization.
Measured: Day 1-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start24 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrillary GlomerulonephritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ladan Zand, Mayo Clinic
- Investigators
- Ladan Zand, Principal investigator, Mayo ClinicFernando Fervenza, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295770
- Sponsor's protocol ID
- 23-006712
- Status last verified
- Apr 2026
- First submitted
- 29 Feb 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Phase 2 Open-Label Trial Evaluating the Efficacy and Safety of Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
- ClinicalTrials.gov ID
- NCT06295770
- Acronym / sponsor ID
- 23-006712
- Conditions
- Fibrillary Glomerulonephritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obinutuzumab in Treatment of Fibrillary Glomerulonephritis | Experimental | Drug: ObinutuzumabPatients with biopsy proven fibrillary GN who have >1 gram/24 hour of proteinuria and eGFR ≥ 20 ml/min/BSA will be treated with Obinutuzumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age
- Biopsy proven fibrillary glomerulonephritis
- Proteinuria > 1.0 g/24hrs prior to initiation of immunosuppressive therapy
- eGFR ≥ 20 ml/min/BSA
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObinutuzumabAlso: GazyvaObinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6. | Drug | Obinutuzumab in Treatment of Fibrillary Glomerulonephritis |
Primary outcome
Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab
Time frame: Baseline, 6 months, 12 months
Measured using 24-hour urine collection reported in mg/24h
5 secondary outcomes
Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab
Time frame: Baseline, 6 months
Rate of complete or partial remission
Time frame: 6 months, 12 months
Improvement in serum albumin
Time frame: Baseline, 6 months, 12 months
Stabilization of kidney function
Time frame: Baseline, 6 months, 12 months
Serious Adverse Events (SAEs)
Time frame: Day 1-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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National Registry of Rare Kidney Diseases
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ladan Zand principal investigator
Mayo Clinic
Fernando Fervenza, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obinutuzumab in people with Fibrillary Glomerulonephritis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Geroux (507-266-0956, Geroux.nicholas@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab (time frame: Baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.