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
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