What side effects are associated with this type of intervention?

Common treatments for Immunoglobulin A Nephropathy (IgAN) that involve B-cell and plasma cell inhibition, such as rituximab and mycophenolate mofetil, can have several side effects. Rituximab may cause infusion reactions, infections, and cytopenias. Mycophenolate mofetil is associated with gastrointestinal disturbances, infections, and hematologic abnormalities. Both treatments require careful monitoring due to their immunosuppressive nature, which can increase the risk of opportunistic infections and other complications.

What prior FDA approvals exist?

There are no specific FDA-approved drugs that directly target B cells and plasma cells to reduce IgA production in the treatment of Immunoglobulin A Nephropathy (IgAN). Current treatments primarily focus on managing symptoms and slowing disease progression, such as the use of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) to control blood pressure and reduce proteinuria. Immunosuppressive therapies like corticosteroids and cyclophosphamide are used in more severe cases, but these are not specifically approved for IgAN. Atacicept, which is being studied for its potential to inhibit B cells and plasma cells, represents a novel approach in this context.

What other types of research exist?

Promising alternatives to Atacicept for IgAN patients include Rituximab and Mycophenolate Mofetil (MMF). Rituximab targets B cells and has shown efficacy in reducing proteinuria and maintaining stable kidney function in patients with IgAN. MMF, often used in combination with corticosteroids, has been effective in inducing remission in IgAN nephritis. Both therapies offer potential benefits for patients who may not respond to or tolerate Atacicept.

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Biological Response Modifier

Atacicept for IgA Nephropathy (ORIGIN 3 Trial)

Phase 3

Recruiting

Research Sponsored by Vera Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at Screening

Be older than 18 years old

Must not have

Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept

History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called atacicept for people with a kidney disease called IgA Nephropathy who still have too much protein in their urine despite other treatments. Atacicept works by calming the immune system to help reduce protein levels in the urine. The study will compare atacicept to see if it is effective and safe.

Who is the study for?

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.

What is being tested?

The trial is testing Atacicept against a placebo in patients with IgA Nephropathy. It's designed to see if Atacicept can help manage the condition better than no active treatment. Participants will be randomly assigned to receive either Atacicept or an inactive substance that looks the same.

What are the potential side effects?

Possible side effects of Atacicept may include reactions at the injection site, increased risk of infections due to immune system suppression, and potentially abnormal blood test results reflecting organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a stable maximum dose of RAASi medication for at least 12 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously participated in the Phase 2b study or received atacicept.

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I have a history of tuberculosis or a positive TB test.

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My kidney function has dropped by half in the last 3 months.

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I have chronic kidney disease along with IgA nephropathy.

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I have had, or will have, a kidney or other organ transplant.

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My IgA nephropathy is not caused by another condition like liver disease or lupus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in urine protein to creatinine ratio (UPCR)

Secondary study objectives

Annualized rate of change in estimated glomerular filtration rate (eGFR)

Other study objectives

Change from baseline in IgA, IgG, IgM, C3, C4 and Gd-IgA1 levels

Change from baseline in estimated glomerular filtration rage (eGFR)

Evaluate serum PK of atacicept

+1 more

Side effects data

From 2009 Phase 2 trial • 256 Patients • NCT00430495

18%

Headache

Nausea

Urinary tract infection

Diarrhoea

Constipation

Nasopharyngitis

Hypertension

Upper respiratory tract infection

Rheumatoid arthritis

Pyrexia

Fibrin D dimer increased

Drug hypersensitivity

Hyperthyroidism

Anaemia

Relapsing fever

Femur fracture

Non-cardiac chest pain

Fallopian tube cyst

Gamma-glutamyltransferase increased

Iron deficiency anaemia

Humerus fracture

Pelvic fracture

Upper limb fracture

Diverticular perforation

Intestinal obstruction

100%

80%

60%

40%

20%

Study treatment Arm

Atacicept 25 mg

Placebo

Atacicept 75 mg

Atacicept 150 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Atacicept Dose 150mgExperimental Treatment1 Intervention

Atacicept 150mg once weekly subcutaneous (SC) injections

Group II: Placebo to match Atacicept (Part C/D)Placebo Group1 Intervention

Placebo to match Atacicept once weekly subcutaneous (SC) injection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atacicept

2006

Completed Phase 2

~600

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Immunoglobulin A Nephropathy (IgAN) include angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), which reduce proteinuria and slow disease progression by lowering blood pressure and decreasing protein excretion. Additionally, emerging treatments like Atacicept target B cells and plasma cells to reduce the production of IgA, the antibody responsible for kidney damage in IgAN. This is crucial for IgAN patients as it directly addresses the underlying cause of the disease, potentially reducing the deposition of IgA in the kidneys and preventing further kidney damage.

Emerging drugs for antibody-mediated rejection after kidney transplantation: a focus on phase II & III trials.Treatment of lupus nephritis: current paradigms and emerging strategies.Rituximab therapy for Type I membranoproliferative glomerulonephritis.