Phase
Condition
Glomerulonephritis
Treatment
Atacicept
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must have the ability to understand and sign a written informed consent form, whichmust be obtained prior to initiation of study assessments
Adult male or female of ≥18 years of age, or as per country specific legally ornationally recognized adult age, who provides written informed consent prior toperforming any study assessments
Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
Total urine protein excretion ≥0.75 g per 24-hour or urine protein-to-creatinineratio (UPCR) ≥0.75 mg/mg based on a 24-hour urine sample
eGFR ≥30 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI)
On a stable prescribed regimen of RASi (angiotensin converting enzyme inhibitor orangiotensin II receptor blocker) for at least 8 weeks that is at the maximum labeledor tolerated dose at screening and from screening to study Day 1
Exclusion
Exclusion Criteria:
IgAN secondary to another condition (eg, liver cirrhosis), or other causes ofmesangial IgA deposition including IgA vasculitis (ie, Henoch-Schonlein purpura),systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis
Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3months of screening)
Evidence of nephrotic syndrome within 6 months of screening (serum albumin <3.0 g/dLin association with UPCR >3.5 mg/mg)
Renal or other organ transplantation prior to or expected during the study, with theexception of corneal transplants
Concomitant chronic renal disease in addition to IgAN (eg, diabetic nephropathy,primary focal segmental glomerulosclerosis, membranous nephropathy, C3glomerulopathy, lupus nephritis)
Study Design
Study Description
Connect with a study center
Vera Therapeutics
Brisbane, California 94005
United StatesActive - Recruiting

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