Primary Focal Segmental GlomerulosclerosisPhase 2NCT04983888
Obinutuzumab in Primary FSGS
A Phase 2 study testing Obinutuzumab in people with Primary Focal Segmental Glomerulosclerosis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Obinutuzumab in inducing complete or partial remission of proteinuria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Focal Segmental Glomerulosclerosis
- 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
- 17 Nov 2021to 16 Jun 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Focal Segmental Glomerulosclerosis (FSGS) lesion
- Foot process effacement ≥ 80% on electron microscopy.
- Presence of nephrotic syndrome (proteinuria > 3.5g/24hrs and serum albumin < 3.5 g/dl) prior to initiation of immunosuppressive therapy.
- Resistant or dependent on therapy, including corticosteroids or calcineurin inhibitors or who have failed rituximab. Patient who have contraindication to or refuse to take high dose corticosteroids are allowed.
Who cannot join
- Genetic or secondary forms of FSGS.
- Hepatitis B, C or HIV positive.
- Pregnant or breast-feeding.
- Active infection.
- Kidney transplant.
- Anemia with Hgb < 8.0 g/dL.
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- 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 received rituximab previously with CD20 count of < 5 cells/microliter at the time of enrollment.
- For women who are not postmenopausal (≥ 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.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Single-center, Phase 2 Open-label Trial Evaluating the Efficacy and Safety of OBINUTUZUMAB in Treatment of Immunosuppression-dependent or Immunosuppression/Treatment-resistant Primary FSGS, or Contraindication/Patient Refusal to Take High Dose Corticosteroids
The purpose of this study is to evaluate the safety and efficacy of Obinutuzumab in inducing complete or partial remission of proteinuria.
- Being tested
- Obinutuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
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 |
|---|---|---|
| Primary Focal Segmental Glomerulosclerosis (FSGS) | Experimental | Subjects with immunosuppression-dependent or immunosuppression/treatment-resistant primary FSGS or contraindication/patient refusal to take high dose corticosteroids, will receive obinutuzumab 1 gram on day 1 and 1 gram on day 15, given intravenously and then an identical course at 6 months. Receives: Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proteinuria
Measured using 24 hour urine collection reported in g/d
Measured: Baseline, 12 months, 24 months
Secondary outcomes (5)
Remission Status at 12 Months
The number of subjects to reach either complete remission or partial remission at 12 months after infusion. Complete remission defined as proteinuria < 0.3g/24 hrs. and no more than 20% decline in eGFR. Partial remission defined as 50% reduction in proteinuria and proteinuria < 3.5 g/24hrs and no more than 20% decline in eGFR.
Measured: 12 months
Change in Serum Albumin
Blood serum collected and reported in g/dL
Measured: Baseline, 12 months, 24 months
Serious Adverse Events (SAEs)
Number of subjects to experience serious adverse events including serious infection defined as severe UTI or pyelonephritis, pneumonias or other systemic infections requiring hospitalization
Measured: 24 months
Proteinuria at 18 Months
Measured using 24 hour urine collection reported in g/d
Measured: 18 months
Proteinuria at 24 Months
Measured using 24 hour urine collection reported in g/d
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start17 Nov 2021
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Focal Segmental GlomerulosclerosisStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Fernando Fervenza, Mayo Clinic
- Investigators
- Fernando Fervenza, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983888
- Sponsor's protocol ID
- 21-003887
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2021
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6.
PubMed 37678236
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 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 Immunosuppression-dependent or Immunosuppression/Treatment-resistant Primary FSGS, or Contraindication/Patient Refusal to Take High Dose Corticosteroids
- ClinicalTrials.gov ID
- NCT04983888
- Acronym / sponsor ID
- 21-003887
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Posted 25 Jun 2026
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 study is to evaluate the safety and efficacy of Obinutuzumab in inducing complete or partial remission of proteinuria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Focal Segmental Glomerulosclerosis (FSGS) | Experimental | Drug: ObinutuzumabSubjects with immunosuppression-dependent or immunosuppression/treatment-resistant primary FSGS or contraindication/patient refusal to take high dose corticosteroids, will receive obinutuzumab 1 gram on day 1 and 1 gram on day 15, given intravenously and then an identical course at 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years of age.
- Biopsy proven Focal Segmental Glomerulosclerosis (FSGS) lesion
- Foot process effacement ≥ 80% on electron microscopy.
- Presence of nephrotic syndrome (proteinuria > 3.5g/24hrs and serum albumin < 3.5 g/dl) prior to initiation of immunosuppressive therapy.
- Resistant or dependent on therapy, including corticosteroids or calcineurin inhibitors or who have failed rituximab. Patient who have contraindication to or refuse to take high dose corticosteroids are allowed.
Key exclusion criteria (12 listed)
- Genetic or secondary forms of FSGS.
- Hepatitis B, C or HIV positive.
- Pregnant or breast-feeding.
- Active infection.
- Kidney transplant.
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 |
|---|---|---|
| Obinutuzumab1g IV on day one and 1 g IV on day 15, followed by identical course at month 6 | Drug | Primary Focal Segmental Glomerulosclerosis (FSGS) |
Primary outcome
Change in Proteinuria
Time frame: Baseline, 12 months, 24 months
Measured using 24 hour urine collection reported in g/d
5 secondary outcomes
Remission Status at 12 Months
Time frame: 12 months
Change in Serum Albumin
Time frame: Baseline, 12 months, 24 months
Serious Adverse Events (SAEs)
Time frame: 24 months
Proteinuria at 18 Months
Time frame: 18 months
Proteinuria at 24 Months
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37678236Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6.
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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. This study is not recruiting at the moment.
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 Primary Focal Segmental Glomerulosclerosis, 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 25 Jun 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?
Yes. Results are posted in the registry (first posted 25 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Proteinuria (time frame: Baseline, 12 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04983888, which also lists 1 linked publication.
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 25 Jun 2026.