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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights

ORIGIN 3 Trial Summary

This trial is testing whether atacicept can help improve proteinuria in adults with IgA nephropathy.

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.Check my eligibility
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.See study design
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.

ORIGIN 3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been on a stable maximum dose of RAASi medication for at least 12 weeks.

ORIGIN 3 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in urine protein to creatinine ratio (UPCR)
Secondary outcome measures
Annualized rate of change in estimated glomerular filtration rate (eGFR)
Other outcome measures
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%
Gamma-glutamyltransferase increased
2%
Non-cardiac chest pain
2%
Drug hypersensitivity
2%
Iron deficiency anaemia
2%
Fibrin D dimer increased
2%
Relapsing fever
2%
Hyperthyroidism
2%
Femur fracture
2%
Anaemia
2%
Fallopian tube cyst
2%
Pyrexia
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

ORIGIN 3 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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being tracked as part of this medical investigation?

"This clinical trial is not presently accepting participants. The protocol was originally posted on May 18th 2021 and last modified on July 6th 2022. Alternatives are available, with 487 trials actively recruiting glomerulonephritis-related candidates as well as a single Atacicept study looking for volunteers."

Answered by AI

Is this research actively searching for new participants?

"This research project is no longer accepting applicants. It was first announced on May 18th 2021, and then revised most recently on July 6th 2022. To find more studies, there are 487 ongoing clinical trials for glomerulonephritis and IGA related conditions as well as one study utilizing atacicept which has openings available."

Answered by AI

Is this experiment pioneering a new methodology?

"The first study of Atacicept commenced in 2021 and was funded by Vera Therapeutics, Inc.. After the successful completion of Phase 2 involving 116 participants, an active clinical trial led by Vera Therapeutics is now underway."

Answered by AI

How many healthcare establishments are participating in the trial within this region?

"This medical experiment is currently in progress at 23 different centres, including the Vera Site #117 situated in Pittsburgh, the Vera Site #105 found near Bethlehem and the Vera Site#109 located in Chicago."

Answered by AI

What potential risks are associated with the administration of Atacicept?

"Given the Phase 2 status of Atacicept, our team assigned it a score of two on the safety scale. This denotes that while safety data exists for this drug, there is no clinical evidence to support its efficacy."

Answered by AI

What prior examinations have been conducted regarding the efficacy of Atacicept?

"Initially tested at Vera Site #711 in 2021, the efficacy of atacicept has been evaluated by 5 clinical trials to date. At present, one study is actively enrolling patients and it's being conducted primarily out of Pittsburgh, Pennsylvania."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
Vera Site #101
Vera Site #109
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Atacicept in Subjects With IgA Nephropathy
2023. "Atacicept in Subjects With IgA Nephropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04716231.
All > Iga Nephropathy
~196 spots leftby May 2025
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