Atacicept in Subjects with IgA Nephropathy

Trial ID or NCT#

NCT04716231

Status

recruiting iconRECRUITING

Purpose

A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)

Official Title

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
    1. Key
Exclusion Criteria:
  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* 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

Investigator(s)

Richard Lafayette
Richard Lafayette
Nephrologist
Professor of Medicine (Nephrology)
Jackson Kim, MD
Jackson Kim, MD
Nephrologist
Clinical Assistant Professor, Medicine - Nephrology

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Contact

Elizabeth Chen
(650) 721-3848