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Atacicept in Subjects With IgA Nephropathy
Recruiting
I'm InterestedTrial ID: NCT04716231
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)
Stanford Investigator(s)
Richard Lafayette
Professor of Medicine (Nephrology)
Eligibility
Key Inclusion 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 Exclusion Criteria:
- 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
Intervention(s):
biological: Atacicept
other: Placebo to match Atacicept
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Elizabeth Chen
(650) 721-3848