Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

Fibrillary Glomerulonephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295770
• Other study ID #: 23-006712
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: Angela Reinke
• Phone: 507-266-1047
• Email: Reinke.Angela[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrillary Glomerulonephritis
• Glomerulonephritis

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Improvement in serum albumin	Blood serum collected and reported in g/dL	Baseline, 6 months, 12 months
Secondary	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
Secondary	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