Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

A Single-Center Phase 2 Open-Label Trial Evaluating the Efficacy and Safety of Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN).

Study Overview

• Status: Recruiting
• Conditions: Fibrillary Glomerulonephritis
• Intervention / Treatment: Drug: Obinutuzumab

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nicholas Geroux; Phone Number: 507-266-0956; Email: geroux.nicholas@mayo.edu
• Study Contact Backup: Name: Corbyn Bendtsen; Phone Number: 507-284-0366; Email: bendtsen.corbyn@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Nicholas Geroux; Phone Number: 507-266-0956; Email: geroux.nicholas@mayo.edu
      • Principal Investigator: Ladan Zand
      • Contact: Corbyn Bendtsen; Phone Number: 507-284-0366; Email: bendtsen.corbyn@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obinutuzumab in Treatment of Fibrillary Glomerulonephritis; Patients with biopsy proven fibrillary GN who have >1 gram/24 hour of proteinuria and eGFR ≥ 20 ml/min/BSA will be treated with Obinutuzumab.	Drug: Obinutuzumab; Obinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6.; Other Names: Gazyva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab	Measured using 24-hour urine collection reported in mg/24h	Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab	Measured using 24-hour urine collection reported in mg/24h	Baseline, 6 months
Rate of complete or partial remission	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	6 months, 12 months
Improvement in serum albumin	Blood serum collected and reported in g/dL	Baseline, 6 months, 12 months
Stabilization of kidney function	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.	Baseline, 6 months, 12 months
Serious Adverse Events (SAEs)	Rate of all Serious Adverse Events (SAEs) including serious infection defined as severe UTI or pyelonephritis, pneumonias or other systemic infections requiring hospitalization.	Day 1-12 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Fernando Fervenza, MD, Mayo Clinic; Principal Investigator: Ladan Zand, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Research

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Nephritis; Glomerulonephritis; Antineoplastic Agents, Immunological; Antineoplastic Agents; obinutuzumab
• Other Study ID Numbers: 23-006712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes