Immunoglobulin A Nephropathy (IgAN)
Conditions
Interventions
Once weekly subcutaneous (SC) injections of Atacicept or placebo by prefilled syringe
Sponsors
Michael Eric
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized Rate of change in eGFR (ie., annualized eGFR total slope) | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine protein to creatinine ratio (UPCR) | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Malaysia, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Sri Lanka, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactTomoko Kubota
Medpace Japan K.K.
Outcome results
None listed