Recruiting NCT06295770
Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Obinutuzumab.
- Who it may be relevant to
- Registry conditions: Fibrillary Glomerulonephritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Center Phase 2 Open-Label Trial Evaluating the Efficacy and Safety of Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
Overview
The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).
Interventions
- Drug Obinutuzumab
Obinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6.
Primary outcome measures
- Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab [Time frame: Baseline, 6 months, 12 months]
Secondary outcome measures (5)
- Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab [Time frame: Baseline, 6 months]
- Rate of complete or partial remission [Time frame: 6 months, 12 months]
- Improvement in serum albumin [Time frame: Baseline, 6 months, 12 months]
- Stabilization of kidney function [Time frame: Baseline, 6 months, 12 months]
- Serious Adverse Events (SAEs) [Time frame: Day 1-12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT06295770 · 23-006712