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A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN) (ORIGIN 3)

Atacicept in Subjects with IgA Nephropathy (ORIGIN 3)

Michael Eric

Vera Therapeutics, Inc.

2000 Sierra Point Parkway, Suite 1200 Brisbane, CA, United States of America

clinicaltrials@veratx.com

Kubota Tomoko

Medpace Japan K.K.

1-5-8, Jingumae, Shibuya-ku, Tokyo

+81-3-4563-7000

RSJapan1@medpace.com

Not Recruiting

May. 20, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Must have the ability to understand and sign a written informed consent form
2. Male or female of >=18 years of age
3. 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
4. Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
5. eGFR >=30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
6. On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at Screening
7. Systolic blood pressure <=150 mmHg and less, and diastolic blood pressure <=90 mmHg

1. 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
2. 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
3. Evidence of rapidly progressive glomerulonephritis (loss of >=50% of eGFR within 3 months of screening)
4. Evidence of nephrotic syndrome within 6 months of screening (serum albumin <30g/L in association with UPCR >3.5 mg/mg
5. Renal or other organ transplantation prior to, or expected during the study
6. Concomitant chronic renal disease in addition to IgAN
7. Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening
8. History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test
9. Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept

Both

Immunoglobulin A Nephropathy (IgAN)

Once weekly subcutaneous (SC) injections of Atacicept or placebo by prefilled syringe

Annualized Rate of change in eGFR (ie., annualized eGFR total slope)

Urine protein to creatinine ratio (UPCR)

+81-3-3263-4801

Dec. 21, 2023

No

United States/United Kingdom/Turkey/Thailand/Taiwan/Sri Lanka/Spain/South Korea/Singapore/Portugal/Poland/Philippines/Malaysia/Italy/Ireland/India/Hong Kong/Greece/Germany/France/Estonia/Denmark/Czech Republic/Croatia/China/Canada/Brazil/Belgium/Australia/Argentina