Recruiting
Phase 2

Obinutuzumab

Sponsor:

Mayo Clinic

Code:

NCT06295770

Conditions

Fibrillary Glomerulonephritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Obinutuzumab

Study Details

Brief summary:

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

Conditions

Fibrillary Glomerulonephritis

Study ID

NCT06295770

Start date

Jun 24, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

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.

Interventions

Obinutuzumab

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

Primary outcome measure

  • Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts and Locations

Central contacts

Nicholas Geroux

507-266-0956Geroux.nicholas@mayo.edu

Corbyn Bendtsen

507-284-0366Bendtsen.corbyn@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Nicholas Geroux

507-266-0956geroux.nicholas@mayo.edu

Corbyn Bendtsen

507-284-0366bendtsen.corbyn@mayo.edu

Principal Investigator:

Ladan Zand

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.