Using Obinutuzumab to treat Fibrillary Glomerulonephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Ladan Zand — Mayo Clinic
• Study coordinator: Nicholas Geroux
• Email: Geroux.nicholas@mayo.edu
• Phone: 507-266-0956

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.