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NCT Number: NCT06295770

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obinutuzumab

Drug

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

Other names: Gazyva

Primary outcomes

  1. Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab

    Time frame: Baseline, 6 months, 12 months

    Measured using 24-hour urine collection reported in mg/24h

Secondary outcomes

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

    Time frame: Baseline, 6 months

    Measured using 24-hour urine collection reported in mg/24h

  2. Rate of complete or partial remission

    Time frame: 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

  3. Improvement in serum albumin

    Time frame: Baseline, 6 months, 12 months

    Blood serum collected and reported in g/dL

  4. Stabilization of kidney function

    Time frame: 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.

  5. Serious Adverse Events (SAEs)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Corbyn Bendtsen

CONTACT

[email protected]

507-284-0366

Nicholas Geroux

CONTACT

[email protected]

507-266-0956

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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