NCT06295770 Obinutuzumab in Treatment of Fibrillary Glomerulonephritis
| NCT ID | NCT06295770 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Fibrillary Glomerulonephritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-06-24 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Ladan Zand
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06295770 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fibrillary Glomerulonephritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06295770 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06295770 currently recruiting?
Yes, NCT06295770 is actively recruiting participants. Contact the research team at Geroux.nicholas@mayo.edu for enrollment information.
Where is the NCT06295770 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06295770 clinical trial?
NCT06295770 is sponsored by Mayo Clinic. The principal investigator is Ladan Zand at Mayo Clinic. The trial plans to enroll 20 participants.