Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

Phase 2

Recruiting

• Conditions: Fibrillary Glomerulonephritis
• Interventions: Drug: Obinutuzumab

• Registration Number: NCT06295770
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-06
• Study Start: 2024-06-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• ≥18 years of age
• Biopsy proven fibrillary glomerulonephritis
• Proteinuria > 1.0 g/24hrs prior to initiation of immunosuppressive therapy
• eGFR ≥ 20 ml/min/BSA

Exclusion Criteria

• Secondary FGN (due to monoclonal gammopathy, autoimmune disease or malignancy)
• Presence of a secondary pathology on biopsy (e.g. diabetic nephropathy)
• 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 have received ACTH and/or mycophenolate mofetil in the last 30 days
• Patient who are on prednisone therapy at a dose > 10 mg/day in the last 15 days
• Patients who received rituximab previously with CD20 count of < 5 cells/microliter at the time of enrollment
• For women who are not postmenopausal (greater than or equal to [>/=] 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Obinutuzumab in Treatment of Fibrillary Glomerulonephritis	Obinutuzumab	Patients with biopsy proven fibrillary GN who have \>1 gram/24 hour of proteinuria and eGFR ≥ 20 ml/min/BSA will be treated with Obinutuzumab.

Primary Outcome Measures

Name	Time	Method
Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab	Baseline, 6 months, 12 months	Measured using 24-hour urine collection reported in mg/24h

Secondary Outcome Measures

Name	Time	Method
Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab	Baseline, 6 months	Measured using 24-hour urine collection reported in mg/24h
Rate of complete or partial remission	6 months, 12 months	Complete remission: Proteinuria \< 0.5g/24 hrs. and no more than 20% decline in eGFR Partial remission: 50% reduction in proteinuria and proteinuria \< 3.5 g/24hrs and no more than 20% decline in eGFR
Improvement in serum albumin	Baseline, 6 months, 12 months	Blood serum collected and reported in g/dL
Stabilization of kidney function	Baseline, 6 months, 12 months	Stabilization is defined as no more than 20% decline in eGFR at 6 months and 12 months. Blood serum collected and reported in mL/min/BSA.
Serious Adverse Events (SAEs)	Day 1-12 months	Rate of all Serious Adverse Events (SAEs) including serious infection defined as severe UTI or pyelonephritis, pneumonias or other systemic infections requiring hospitalization.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States