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

NCT04983888•Mayo Clinic

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

November 17, 2021

Primary Completion Date

June 16, 2025

Completion Date

June 16, 2025

Last Updated

September 11, 2025

Enrollment

ACTUAL participants

Conditions

Primary Focal Segmental Glomerulosclerosis

Interventions

Obinutuzumab

DRUG

Study of WAL0921 in Patients With Glomerular Kidney Diseases

NCT06466135

Diabetic NephropathiesPrimary Focal Segmental Glomerulosclerosis+3 more

View study

COMPLETEDPHASE2

A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)

NCT01665391

Primary Focal Segmental Glomerulosclerosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions