Phase
Condition
Nephritis
Glomerulonephritis
Treatment
Obinutuzumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting

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