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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

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 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
8%
Nausea
6%
Urinary tract infection
6%
Diarrhoea
6%
Constipation
5%
Nasopharyngitis
5%
Hypertension
5%
Upper respiratory tract infection
3%
Rheumatoid arthritis
2%
Fallopian tube cyst
2%
Gamma-glutamyltransferase increased
2%
Fibrin D dimer increased
2%
Relapsing fever
2%
Drug hypersensitivity
2%
Femur fracture
2%
Anaemia
2%
Iron deficiency anaemia
2%
Pyrexia
2%
Non-cardiac chest pain
2%
Hyperthyroidism
2%
Humerus fracture
2%
Pelvic fracture
2%
Upper limb fracture
2%
Diverticular perforation
2%
Intestinal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atacicept 25 mg
Placebo
Atacicept 75 mg
Atacicept 150 mg

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

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.

Find a Location

Who is running the clinical trial?

Vera Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
390 Total Patients Enrolled
Rubeen IsraniStudy DirectorSr. Director, Clinical Development
Joanne CurleyStudy DirectorChief Development Officer
1 Previous Clinical Trials
360 Total Patients Enrolled

Media Library

Immunoglobulin A Nephropathy Research Study Groups: Atacicept Dose 150mg, Placebo to match Atacicept (Part C/D)
Immunoglobulin A Nephropathy Clinical Trial 2023: Atacicept Highlights & Side Effects. Trial Name: NCT04716231 — Phase 3
~114 spots leftby May 2025
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