Atacicept for Nephrotic Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of atacicept, a treatment for individuals with certain kidney problems that cause excessive protein in urine and affect kidney function. The study divides participants into groups based on specific kidney issues: IgAN or IgAVN, pMN, and primary nephrotic syndrome (such as MCD or FSGS). Suitable candidates have biopsy-proven kidney conditions, experience protein in their urine, and have not responded to standard treatments. Participants will help researchers determine how atacicept can reduce protein levels and preserve kidney function. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
The trial requires participants to be on a stable prescribed standard of care treatment regimen, so you may not need to stop your current medications. However, the protocol does not specify any changes, so it's best to discuss your specific situation with the trial coordinators.
Is there any evidence suggesting that atacicept is likely to be safe for humans?
Why do researchers think this study treatment might be promising for nephrotic syndrome?
Researchers are excited about atacicept because it offers a unique approach to treating nephrotic syndrome. Unlike traditional treatments like corticosteroids and immunosuppressants, which broadly dampen the immune system, atacicept specifically targets and reduces the activity of B-cells and plasma cells involved in producing harmful antibodies. This targeted action could lead to fewer side effects and improved effectiveness, especially in patients with conditions like IgAN, IgAVN, pMN, and primary nephrotic syndrome linked to specific antibodies. Additionally, atacicept's mechanism might provide hope for those not responding well to existing therapies.
What evidence suggests that atacicept might be an effective treatment for nephrotic syndrome?
This trial will evaluate the effectiveness of atacicept in treating different types of nephrotic syndrome. Research has shown that atacicept may help treat conditions such as IgA Nephropathy (IgAN) and IgA Vasculitis Nephropathy (IgAVN), which are included in one of the trial arms. In earlier studies, patients taking atacicept had less protein in their urine, an important indicator of kidney health. Another arm of this trial will focus on Primary Membranous Nephropathy (pMN), where atacicept treatment significantly lowered the protein-to-creatinine ratio in urine. This suggests it might help reduce high protein levels in urine, a common issue in kidney diseases. The trial will also include an arm for primary nephrotic syndrome cases like Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS), where atacicept was found to be safe and helped maintain kidney function over time. These findings suggest that atacicept could effectively manage symptoms and protect kidney health in these conditions.36789
Who Is on the Research Team?
Pam Winterberg
Principal Investigator
Vera Therapeutics
Are You a Good Fit for This Trial?
This trial is for individuals at least 10 years old, weighing over 40 kg, with certain kidney conditions like IgA Nephropathy or Focal Segmental Glomerulosclerosis. They should have a minimum eGFR of 20 mL/min/1.73m2 and be on stable standard treatments. It's not suitable for those who don't meet the specific disease requirements.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly subcutaneous injections of atacicept
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atacicept
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vera Therapeutics, Inc.
Lead Sponsor