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Atacicept for IgA Nephropathy (ORIGIN EXTEND Trial)

Phase 2
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
For Atacicept Drug Holiday Group only: Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90mmHg at screening and Day 1
Be older than 18 years old
Must not have
Unwillingness or lack of capacity to follow all study procedures
Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline until end of study up to week156
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to gather information on the safety and how well patients with IgA nephropathy tolerate atacicept, a drug previously studied in the Vera trial for IgA nephropathy."

Who is the study for?
This trial is for patients with IgA Nephropathy, a kidney disease, who have completed the Vera trial. It's designed to gather more information on the long-term safety and effects of Atacicept in this specific group.
What is being tested?
The study focuses on evaluating the continued use of Atacicept at a dose of 150 mg. The goal is to understand its long-term impact on patients with IgA Nephropathy who previously participated in related research.
What are the potential side effects?
While specific side effects are not listed here, participants can expect similar reactions as observed in previous trials or associated with immune-modulating drugs like Atacicept.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood pressure is 150/90 mmHg or lower.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable or unwilling to follow the study's procedures.
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My kidney function has rapidly declined by half in the last 3 months.
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I have been treated for latent TB for at least 4 weeks without re-exposure.
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I have had or am expected to have an organ transplant, except for corneal transplants.
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I have not had major surgery in the last 6 weeks and do not plan any during the study.
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I have had my spleen removed.
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I am on dialysis or will start it within 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline until end of study up to week156
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline until end of study up to week156 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events observed during the dosing period
Secondary study objectives
To evaluate the effect of atacicept on change in proteinuria
To evaluate the effect of atacicept on hematuria
To evaluate the effect of atacicept on serum galactose-deficient IgA1 (Gd-IgA1) levels
+1 more

Side effects data

From 2012 Phase 2 & 3 trial • 461 Patients • NCT00624338
20%
Headache
15%
Upper respiratory tract infection
14%
Urinary tract infection
13%
Nasopharyngitis
10%
Injection site reaction
9%
Back pain
8%
Bronchitis
7%
Nausea
6%
Diarrhoea
6%
Injection site erythema
6%
Cough
5%
Pyrexia
5%
Hypertension
5%
Sinusitis
5%
Abdominal pain upper
3%
Injection site pruritus
3%
Pneumonia
3%
Influenza
2%
Hypotension
1%
Vasculitis gastrointestinal
1%
Intra-uterine death
1%
Sepsis
1%
Pelvic inflammatory disease
1%
Hip arthroplasty
1%
Angina pectoris
1%
Social stay hospitalisation
1%
Arthritis bacterial
1%
Pancreatitis
1%
Vomiting
1%
Peritonitis
1%
Laceration
1%
Myocardial infarction
1%
Coronary artery disease
1%
Cervix carcinoma stage 0
1%
Dyspnoea
1%
Malaise
1%
Anaphylactic shock
1%
Biopsy cervix
1%
International normalised ratio increased
1%
Cholelithiasis
1%
Escherichia urinary tract infection
1%
Vasculitis
1%
Appendicitis
1%
Muscular weakness
1%
Serum sickness
1%
Kidney infection
1%
Pyelonephritis acute
1%
Gastrointestinal disorder
1%
Pancreatitis acute
1%
Periproctitis
1%
Chillblains
1%
Atrial flutter
1%
Transient ischaemic attack
1%
Uterine polyp
1%
Affect lability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atacicept 75 mg
Atacicept 150 mg
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Atacicept 150mg once weekly subcutaneous (SC) injectionExperimental Treatment1 Intervention
Other Names: VT-001
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atacicept 150 mg
2013
Completed Phase 3
~770

Find a Location

Who is running the clinical trial?

Vera Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
766 Total Patients Enrolled
Zeeshan KhawajaStudy DirectorVice President, Clinical Development
1 Previous Clinical Trials
376 Total Patients Enrolled
~317 spots leftby May 2028
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