Efficacy and Safety of Atacicept in Patients with IgA Nephropathy
- Conditions
- Health Condition 1: N29- Other disorders of kidney and ureter in diseases classified elsewhere
- Registration Number
- CTRI/2021/10/037121
- Lead Sponsor
- Vera Therapeutics Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Key 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.Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
4.Total urine protein excretion = 1g per 24-hour or urine protein to creatinine ratio (UPCR) = 1 mg/mg (=100 mg/mmol) based on a 24-hour urine sample during the Screening Period
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 labelled or tolerated dose
7.Systolic blood pressure =150 mmHg and diastolic blood pressure =90 mmHg
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
2.Evidence of rapidly progressive glomerulonephritis (loss of = 50% of eGFR within 3 months of screening)
3.Evidence of nephrotic syndrome within 6 months of screening (serum albumin <30g/L in association with UPCR >3.5 mg/mg [350 mg/mmol]
4.Total urine protein excretion = 5g per 24-hour or urine protein to creatinine ratio (UPCR) = 5 mg/mg (=500 mg/mmol) based on a 24-hour urine sample during the Screening Period
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the effect of atacicept compared to placebo on change in proteinuria in <br/ ><br>adult subjects with IgANTimepoint: Week 24
- Secondary Outcome Measures
Name Time Method Evaluate the effect of atacicept compared to placebo on change in proteinuria in <br/ ><br>adult subjects with IgAN.Timepoint: Week 36