Obinutuzumab in Primary FSGS

NCT04983888 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 21-003887
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Obinutuzumab in inducing complete or partial remission of proteinuria.

Conditions

Primary Focal Segmental Glomerulosclerosis

Outcome Measures

Primary Outcomes (1)

• Change in proteinuria

  Measured using 24 hour urine collection reported in mg/24h

  Baseline, 6 months, 12 months

Secondary Outcomes (6)

• Remission status at 6 months

  6 months

• Remission status at 12 months

  12 months

• Change in serum albumin

  Baseline, 6 months, 12 months

• Serious Adverse Events (SAEs)

  24 months

• Proteinuria at 18 months

  18 months

Study Arms (1)

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.

Drug: Obinutuzumab

Interventions

Obinutuzumab DRUG

1g IV on day one and 1 g IV on day 15, followed by identical course at month 6

Primary Focal Segmental Glomerulosclerosis (FSGS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 37678236 DERIVED

MeSH Terms

Interventions

obinutuzumab

Study Officials

• Fernando Fervenza, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 30, 2021
• Study Start: November 17, 2021
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

US (1)