Atacicept in Subjects With IgA Nephropathy
Trial ID or NCT#
Status
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
- - 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
- - 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)
Contact us to find out if this trial is right for you.
Contact
Elizabeth Chen
(650) 721-3848
View on ClinicalTrials.gov