Obinutuzumab in Primary FSGS

Primary Focal Segmental Glomerulosclerosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04983888
• Other study ID #: 21-003887
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 17, 2021
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glomerulosclerosis, Focal Segmental
• Primary Focal Segmental Glomerulosclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proteinuria	Measured using 24 hour urine collection reported in mg/24h	Baseline, 6 months, 12 months
Secondary	Remission status at 6 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.	6 months
Secondary	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
Secondary	Change in serum albumin	Blood serum collected and reported in g/dL	Baseline, 6 months, 12 months
Secondary	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
Secondary	Proteinuria at 18 months	Measured using 24 hour urine collection reported in mg/24h	18 months
Secondary	Proteinuria at 24 months	Measured using 24 hour urine collection reported in mg/24h	24 months