RecruitingPhase 2NCT07020923

Monthly Dosing of Atacicept in IgAN

A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients With IgAN

Sponsor

Vera Therapeutics, Inc.

Enrollment

90 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

IgA Nephropathy (IgAN)Berger Disease

Summary

This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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

Exclusion Criteria5

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)

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