Status:
ACTIVE_NOT_RECRUITING
Atacicept in Subjects With IgA Nephropathy
Lead Sponsor:
Vera Therapeutics, Inc.
Conditions:
IgA Nephropathy
Berger Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)
Detailed Description
This is a multi-part study comprising of the original Phase 2b study and the addition of a separate pivotal Phase 3 study. After the completion of the primary results for the Ph 2b dose ranging study...
Eligibility Criteria
Inclusion
- Key
- Must have the ability to understand and sign a written informed consent form
- Male or female of ≥18 years of age
- Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening Period
- Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
- eGFR ≥ 30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at Screening
- Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg
- Key
Exclusion
- IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis
- Total urine protein excretion ≥ 5g per 24-hour or urine protein to creatinine ratio (UPCR) ≥ 5 mg/mg based on a 24-hour urine sample during the Screening Period
- Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of eGFR within 3 months of screening)
- Evidence of nephrotic syndrome within 6 months of screening (serum albumin \<30g/L in association with UPCR \>3.5 mg/mg
- Renal or other organ transplantation prior to, or expected during the study
- Concomitant chronic renal disease in addition to IgAN
- Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) \>7.5% at screening
- History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test
- Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept
Key Trial Info
Start Date :
June 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT04716231
Start Date
June 29 2023
End Date
July 1 2028
Last Update
September 30 2025
Active Locations (1)
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1
ORIGIN 3 Global Site Contact Information
Brisbane, California, United States, 94005