Using Obinutuzumab to treat Fibrillary Glomerulonephritis

A Single-Center Phase 2 Open-Label Trial Evaluating the Efficacy and Safety of Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

This study is testing if the drug Obinutuzumab can help adults with fibrillary glomerulonephritis improve their kidney function and slow down the disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Drugs / interventions: rituximab, cyclophosphamide, prednisone, Obinutuzumab
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT06295770 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of Obinutuzumab in patients diagnosed with fibrillary glomerulonephritis (FGN). Participants must be at least 18 years old and have biopsy-proven FGN with significant proteinuria. The study will monitor the outcomes of treatment with Obinutuzumab, focusing on its impact on kidney function and disease progression. The trial is being conducted at the Mayo Clinic in Rochester, Minnesota.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with biopsy-confirmed fibrillary glomerulonephritis and significant proteinuria.

Not a fit: Patients with secondary fibrillary glomerulonephritis or those with certain comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from fibrillary glomerulonephritis.

How similar studies have performed: While this approach is being tested in this specific context, similar studies using monoclonal antibodies for kidney diseases have shown promise.

Eligibility criteria

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

Where this trial is running

Rochester, Minnesota

• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Ladan Zand — Mayo Clinic
• Study coordinator: Nicholas Geroux

Conditions Fibrillary Glomerulonephritis