OBINUTUZUMAB in Treatment of Fibrillary Glomerulonephritis

Overview

About this study

The purpose of this study is to determine if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/27/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ladan Zand, M.D.

Open for enrollment

Contact information:

Angela Reinke

(507) 266-1047

Reinke.Angela@mayo.edu

More information

Publications

Publications are currently not available