Clinical trial NCT06295770: Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
Official title: A Single-Center Phase 2 Open-Label Trial Evaluating the Efficacy and Safety of Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Fibrillary Glomerulonephritis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab
timeFrame: Baseline, 6 months
measure: Rate of complete or partial remission
timeFrame: 6 months, 12 months
measure: Improvement in serum albumin
timeFrame: Baseline, 6 months, 12 months
measure: Stabilization of kidney function
timeFrame: Baseline, 6 months, 12 months
measure: Serious Adverse Events (SAEs)
timeFrame: Day 1-12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ladan Zand
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Fernando Fervenza, MD
role: PRINCIPAL_INVESTIGATOR
References: