Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

Mayo Clinic

Status and phase: Enrolling; Phase 2

Conditions: Fibrillary Glomerulonephritis

Treatments: Drug: Obinutuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06295770

23-006712

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

Experimental group

Description:

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.

Treatment:

Drug: Obinutuzumab