Atacicept for IgA Nephropathy

Overseen By Vera Therapeutics, Inc. Clinical Trials Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vera Therapeutics, Inc.

Must be taking: RASi

Disqualifiers: IgA vasculitis, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests atacicept, a treatment for IgA nephropathy, a kidney disease that can cause damage over time. The study aims to determine the best dosing schedule by comparing different weekly and monthly doses. Individuals diagnosed with IgA nephropathy through a kidney biopsy and who have high protein levels in their urine may qualify for this trial. Participants must also maintain a stable kidney medication plan to join. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in treatment.

Do I need to stop my current medications for the trial?

The trial requires that you stay on a stable dose of RASi (a type of blood pressure medication) for at least 8 weeks before starting and throughout the study. The protocol does not specify if you need to stop other medications, so it's best to discuss this with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that atacicept is generally safe for patients. In a study involving people with IgA nephropathy, the safety of atacicept matched earlier findings. Long-term data over 96 weeks indicated that atacicept was well tolerated, with no major safety issues reported. These studies suggest that atacicept could be a safe choice for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Atacicept for IgA Nephropathy because it targets the disease in a unique way. Unlike current treatments, which often focus on reducing symptoms or inflammation, Atacicept directly targets B cells and plasma cells, which are involved in the production of IgA antibodies that contribute to kidney damage in this condition. Additionally, Atacicept offers flexibility in administration, with some doses being given via subcutaneous injection either weekly or monthly, allowing for potentially improved patient compliance and convenience. This targeted approach and flexible dosing schedule have the potential to provide a more effective and patient-friendly alternative to current treatment options like corticosteroids and immunosuppressants.

What evidence suggests that this trial's treatments could be effective for IgA Nephropathy?

Research shows that atacicept targets a crucial part of the immune system involved in IgA nephropathy, a kidney disease. It lowers the activity of certain proteins (BAFF and APRIL) that influence B cells, a type of immune cell. Studies have found that atacicept significantly reduces proteinuria, which is the presence of excess protein in the urine, a common issue in IgA nephropathy. Specifically, it has lowered galactose-deficient IgA1 by 68% and eliminated blood in the urine in 81% of patients. Long-term studies indicate that it continues to effectively manage disease markers for up to 96 weeks. These findings suggest that atacicept could be a promising treatment for managing IgA nephropathy. Participants in this trial will receive different doses of atacicept to evaluate its effectiveness and safety. ^{1 3 4 5 6}

Who Is on the Research Team?

Zeeshan Khawaja

Principal Investigator

Vice President, Clinical Development

Are You a Good Fit for This Trial?

Adults over 18 with IgA Nephropathy, a kidney condition, can join this trial if they have certain levels of protein in their urine and their kidneys are still working at a minimum level. They must be on stable blood pressure medication for at least 8 weeks. People with severe kidney issues, other chronic kidney diseases, or those who've had organ transplants (except corneal) cannot participate.

Inclusion Criteria

I am an adult who has agreed to participate in this study.

Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments

Total urine protein excretion ≥0.75 g per 24-hour or urine protein-to-creatinine ratio (UPCR) ≥0.75 mg/mg based on a 24-hour urine sample

Exclusion Criteria

Evidence of nephrotic syndrome within 6 months of screening (serum albumin <3.0 g/dL in association with UPCR >3.5 mg/mg)

Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)

I have IgAN and another chronic kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atacicept via subcutaneous injection, with dosing regimens including weekly and monthly administration

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atacicept

Trial Overview

The study is testing Atacicept's effectiveness when given monthly to treat IgA Nephropathy. It's an open-label Phase 2 trial where participants receive different dosing schedules of the drug across multiple centers to compare outcomes.

How Is the Trial Designed?

Group I: Atacicept Arm 5 Experimental Treatment 0 Interventions

Atacicept dose E administered subcutaneous (sc) injection weekly for 24 weeks, followed by monthly sc injections

Group II: Atacicept Arm 4 Experimental Treatment 0 Interventions

Atacicept dose D administered subcutaneous (sc) injection weekly

Group III: Atacicept Arm 3 Experimental Treatment 0 Interventions

Atacicept dose C administered subcutaneous (sc) injection monthly

Group IV: Atacicept Arm 2 Experimental Treatment 0 Interventions

Atacicept dose B administered subcutaneous (sc) injection monthly

Group V: Atacicept Arm 1 Experimental Treatment 1 Intervention

Atacicept dose A administered subcutaneous (sc) injection monthly

Who Is Running the Clinical Trial?

Vera Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

1,200+

Citations

1.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2510198

A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy

The ability of atacicept to decrease BAFF and APRIL signaling of B cells directly targets the upstream pathophysiology of IgA nephropathy. A ...

2.

ir.veratx.com

ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-positive-origin-phase-3-data

News Release

Atacicept treatment also led to improvements in secondary endpoints: Gd-IgA1 was reduced by 68% and hematuria was resolved in 81% of ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39462308/

Long-Term Results from an Open-Label Extension Study of ...

This study evaluated the long-term efficacy and safety of atacicept in patients with IgA nephropathy over 96 weeks. Methods: Participants ...

4.

journals.lww.com

journals.lww.com/jasn/fulltext/2025/04000/long_term_results_from_an_open_label_extension.15.aspx

Long-Term Results from an Open-Label Extension Study of...

Atacicept was generally well tolerated over 96 weeks. These findings suggest atacicept may effectively manage IgA nephropathy by reducing disease markers and ...

5.

ccjm.org

ccjm.org/page/asn-2025/atacicept-significantly

Atacicept significantly reduced proteinuria in patients with ...

Treatment with atacicept also significantly reduced hematuria and galactose-deficient IgA1 compared with placebo, with a favorable safety ...

6.

veratx.com

veratx.com/science/atacicept-in-igan/

Atacicept in IgAN

Phase 2b clinical trial evaluating the safety and efficacy of atacicept in patients with IgAN who continue to have persistent proteinuria and remain at high ...