Obinutuzumab for Focal Segmental Glomerulosclerosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a medication called Obinutuzumab to see if it can help reduce protein levels in the urine of patients with kidney problems. The medication works by helping the immune system target and attack harmful cells. The goal is to find out if it is safe and effective for these patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that patients who are resistant or dependent on certain therapies, like corticosteroids, are eligible, which might suggest you can continue some treatments.
Is Obinutuzumab generally safe for humans?
Obinutuzumab, also known as Gazyva, has been studied for safety in humans, primarily for blood cancers. Common side effects include mild to moderate reactions during infusion, like fever or chills, and low white blood cell counts. Serious allergic reactions are rare in humans, even though they were observed in animal studies.12345
How is the drug Obinutuzumab unique for treating Focal Segmental Glomerulosclerosis?
Obinutuzumab is unique because it is a type II anti-CD20 monoclonal antibody that targets B-cells, which are part of the immune system, and it is glycoengineered to enhance its ability to kill these cells. This mechanism is different from other treatments for Focal Segmental Glomerulosclerosis, which may not specifically target B-cells or use this advanced engineering to increase effectiveness.12345
What data supports the effectiveness of the drug Obinutuzumab for Focal Segmental Glomerulosclerosis?
Obinutuzumab has shown effectiveness in treating certain types of blood cancers, like chronic lymphocytic leukemia and follicular lymphoma, by targeting and killing specific immune cells. While it hasn't been directly studied for Focal Segmental Glomerulosclerosis, its ability to deplete key B-cell subsets in patients with end-stage renal disease suggests potential benefits for kidney-related conditions.13456
Who Is on the Research Team?
Fernando Fervenza, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Adults with FSGS, a kidney disease causing protein loss in urine and low blood albumin levels. Participants must have tried other treatments without success or cannot take high-dose steroids. Excluded are those with genetic FSGS, infections like hepatitis or HIV, pregnant/breastfeeding women, severe anemia or low platelets, and recent recipients of certain drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive obinutuzumab 1 gram on day 1 and 1 gram on day 15, given intravenously, with an identical course at 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including remission status and proteinuria levels
What Are the Treatments Tested in This Trial?
Interventions
- Obinutuzumab
Obinutuzumab is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD