Obinutuzumab in Primary FSGS

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.

Study Overview

• Status: Completed
• Conditions: Primary Focal Segmental Glomerulosclerosis
• Intervention / Treatment: Drug: Obinutuzumab

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary Focal Segmental Glomerulosclerosis (FSGS); 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.	Drug: Obinutuzumab; 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Proteinuria	Measured using 24 hour urine collection reported in g/d	Baseline, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months
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.	12 months
Change in Serum Albumin	Blood serum collected and reported in g/dL	Baseline, 12 months, 24 months
Proteinuria at 18 Months	Measured using 24 hour urine collection reported in g/d	18 months
Proteinuria at 24 Months	Measured using 24 hour urine collection reported in g/d	24 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Fernando Fervenza, MD, Mayo Clinic

Publications and helpful links

General 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.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Glomerulonephritis; Nephritis; Glomerulosclerosis, Focal Segmental; Antineoplastic Agents, Immunological; Antineoplastic Agents; obinutuzumab
• Other Study ID Numbers: 21-003887

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No