Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

Last updated: April 3, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

2

Condition

Nephritis

Glomerulonephritis

Treatment

Obinutuzumab

Clinical Study ID

NCT06295770
23-006712
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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 clinicallaboratory finding giving reasonable suspicion of a disease or condition thatcontraindicates the use of an investigational drug or that may affect theinterpretation of the results or render the patient at high risk from treatmentcomplication

  • 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/microliterat the time of enrollment

  • For women who are not postmenopausal (greater than or equal to [>/=] 12 months ofnon-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/oruterus): 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 (%) peryear, during the treatment period and for at least 18 months after the last dose ofstudy drug

  • For men: agreement to remain abstinent or use two adequate methods forcontraception, including at least one method with failure rate of less than 1% peryear during the treatment period and for at least 6 months (180 days) after the lastdose of drug

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Obinutuzumab
Phase: 2
Study Start date:
June 24, 2024
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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