Atacicept in subjects with IgA Nephropathy: a Phase 2b/3, Multi-part, randomized, double-blinded, placebo- controlled trial

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

•Male or female of greater than or equal to 18 years of age.
•Total urine protein excretion greater than 1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) greater than 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 greater than or equal to 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 labelled or tolerated dose at Screening.
•Systolic blood pressure less than or equal to 150 mmHg and diastolic blood pressure less than or equal to 90 mmHg.

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 greater than or equal to 5g per 24-hour or urine protein to creatinine ratio (UPCR) greater than or equal to 5 mg/mg based on a 24-hour urine sample during the Screening Period
•Evidence of rapidly progressive glomerulonephritis (loss of greater than or equal to 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in urine protein to creatinine ratio (UPCR). <br>UPCR based on 24-hour urine collection.<br> [Baseline, 36 Weeks]<br>

Secondary Outcome Measures

Name	Time	Method
Annualized rate of change in estimated glomerular filtration rate (eGFR) [Baseline, Week 52, 104]<br>Serum galactose deficient IgA1 (Gd-IgA1) levels [Baseline, Weeks 36, 52, and 104]<br> Composite kidney failure endpoint defined as experiencing at least one of the following during the study:<br>• At least a 30% reduction in eGFR sustained for at least 30 days<br>• eGFR <15 mL/min/1.73m2 sustained for at least 30 days<br>• Chronic dialysis =30 days<br>• Kidney transplantation<br>• Death from kidney failure<br> [Over 104 weeks]<br>