Atacicept for IgA Nephropathy
(ORIGIN 3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called atacicept for individuals with IgA nephropathy, a kidney condition that can cause blood and protein in the urine. The trial aims to determine if weekly injections of atacicept can reduce these symptoms. Some participants will receive a placebo, a harmless substance resembling the treatment, to compare results. Individuals with IgA nephropathy, confirmed by a kidney biopsy and with protein levels in their urine above a certain threshold, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially bringing a new treatment to market.
Will I have to stop taking my current medications?
The trial requires participants to be on a stable regimen of RAASi (a type of blood pressure medication) for at least 12 weeks before starting. The protocol does not specify if you need to stop other medications, so it's best to discuss with the trial team.
Is there any evidence suggesting that Atacicept is likely to be safe for humans?
Research has shown that atacicept is generally safe for people with IgA nephropathy. In one study, the side effects of atacicept matched those of a placebo, an inactive treatment. Another study observed atacicept over 96 weeks and found it safe for long-term use. Although some participants experienced infections, no major safety concerns arose. Overall, these findings support the safety of atacicept for potential participants.12345
Why do researchers think this study treatment might be promising for IgA Nephropathy?
Unlike the standard of care for IgA Nephropathy, which typically includes treatments like corticosteroids and blood pressure medications, Atacicept acts on a different biological pathway. Atacicept is unique because it targets the activity of B lymphocytes, which are cells involved in the production of antibodies that can damage the kidneys. This targeted approach may offer a more precise intervention compared to traditional therapies that broadly suppress the immune system. Researchers are excited about Atacicept because its mechanism could potentially reduce kidney damage while minimizing side effects associated with broader immunosuppressive treatments.
What evidence suggests that Atacicept might be an effective treatment for IgA Nephropathy?
Studies have shown that atacicept looks promising for treating IgA nephropathy, a kidney disease. Research indicates that atacicept can reduce key disease markers, such as a specific protein linked to the condition and blood in the urine, over an extended period. In this trial, participants will receive either atacicept or a placebo. In previous studies, patients taking atacicept demonstrated improvements in protein levels in their urine and kidney function over 96 weeks. These results suggest that atacicept could effectively manage symptoms of IgA nephropathy and slow the disease's progression.12346
Who Is on the Research Team?
Zeeshan Khawaja
Principal Investigator
Vice President, Clinical Development
Are You a Good Fit for This Trial?
Adults (18+) with IgA Nephropathy, a kidney disease, who have not responded well to standard treatments can join. They must have had a biopsy confirming the diagnosis within the last 10 years and stable blood pressure. People with related conditions like lupus or those with very severe kidney issues, uncontrolled diabetes, or past tuberculosis are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Double-blind Treatment
Participants receive either atacicept or placebo in a double-blind manner to evaluate efficacy and safety in reducing proteinuria
Open-label Treatment
Participants receive open-label atacicept treatment to further assess safety and efficacy
Safety 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