Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

NCT06295770 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-006712
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibrillary Glomerulonephritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab

  Baseline, 6 months

• Rate of complete or partial remission

  6 months, 12 months

• Improvement in serum albumin

  Baseline, 6 months, 12 months

• Stabilization of kidney function

  Baseline, 6 months, 12 months

• Serious Adverse Events (SAEs)

  Day 1-12 months

Study Arms (1)

Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

EXPERIMENTAL

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

Interventions

Obinutuzumab DRUG

Obinutuzumab 1g IV on day one and 1 g IV on day 15, followed by identical course at month 6.

Also known as: Gazyva

Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Biopsy proven fibrillary glomerulonephritis
• Proteinuria \> 1.0 g/24hrs prior to initiation of immunosuppressive therapy
• eGFR ≥ 20 ml/min/BSA

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

obinutuzumab

Study Officials

• Ladan Zand

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Fernando Fervenza, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Geroux

CONTACT

507-266-0956; Geroux.nicholas@mayo.edu

Corbyn Bendtsen

CONTACT

507-284-0366; Bendtsen.corbyn@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)