Fibrillary Glomerulonephritis
Conditions
Brief summary
The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).
Interventions
DRUGObinutuzumab
Obinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab | Baseline, 6 months, 12 months | Measured using 24-hour urine collection reported in mg/24h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab | Baseline, 6 months | Measured using 24-hour urine collection reported in mg/24h |
| Rate of complete or partial remission | 6 months, 12 months | Complete remission: Proteinuria \< 0.5g/24 hrs. and no more than 20% decline in eGFR Partial remission: 50% reduction in proteinuria and proteinuria \< 3.5 g/24hrs and no more than 20% decline in eGFR |
| Improvement in serum albumin | Baseline, 6 months, 12 months | Blood serum collected and reported in g/dL |
| Stabilization of kidney function | Baseline, 6 months, 12 months | Stabilization is defined as no more than 20% decline in eGFR at 6 months and 12 months. Blood serum collected and reported in mL/min/BSA. |
| Serious Adverse Events (SAEs) | Day 1-12 months | Rate of all Serious Adverse Events (SAEs) including serious infection defined as severe UTI or pyelonephritis, pneumonias or other systemic infections requiring hospitalization. |
Countries
United States
Contacts
CONTACTNicholas Geroux
CONTACTCorbyn Bendtsen
PRINCIPAL_INVESTIGATORLadan Zand
Mayo Clinic
PRINCIPAL_INVESTIGATORFernando Fervenza, MD
Mayo Clinic
Outcome results
None listed