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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04983888

Enrollment

Registered

2021-07-30

Start date

2021-11-17

Completion date

2025-06-16

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Focal Segmental Glomerulosclerosis

Brief summary

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

Interventions

DRUGObinutuzumab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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. * 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Remission Status at 12 Months	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.
Change in Serum Albumin	Baseline, 12 months, 24 months	Blood serum collected and reported in g/dL
Serious Adverse Events (SAEs)	24 months	Number of subjects to experience serious adverse events including serious infection defined as severe UTI or pyelonephritis, pneumonias or other systemic infections requiring hospitalization
Proteinuria at 18 Months	18 months	Measured using 24 hour urine collection reported in g/d
Proteinuria at 24 Months	24 months	Measured using 24 hour urine collection reported in g/d

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORFernando Fervenza, MD

Mayo Clinic

Participant flow

Recruitment details

\[Not Specified\]

Pre-assignment details