Monthly Dosing of Atacicept in IgAN
Running, not enrolling · Phase 2
Conditions studied: IgA Nephropathy (IgAN), Berger Disease
In brief
This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept
Key facts
- Study ID
- NCT07020923
- Run by
- Vera Therapeutics, Inc.
- People needed
- 90
- Starts
- 2025-05-29
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments
- Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provides written informed consent prior to performing 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-creatinine ratio (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 Epidemiology Collaboration (CKD-EPI)
- On a stable prescribed regimen of RASi (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker) for at least 8 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1
You may not qualify if…
- IgAN secondary to another condition (eg, liver cirrhosis), or other causes of mesangial 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 3 months of screening)
- Evidence of nephrotic syndrome within 6 months of screening (serum albumin <3.0 g/dL in association with UPCR >3.5 mg/mg)
- Renal or other organ transplantation prior to or expected during the study, with the exception of corneal transplants
- Concomitant chronic renal disease in addition to IgAN (eg, diabetic nephropathy, primary focal segmental glomerulosclerosis, membranous nephropathy, C3 glomerulopathy, lupus nephritis)
Where it is running
- Vera Therapeutics — Brisbane, California, United States
Full record on ClinicalTrials.gov
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