Berger Disease, IgA Nephropathy (IgAN)
Conditions
Brief summary
This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept
Detailed description
This Phase 2 study is to explore the effectiveness, safety and tolerability of different dosing regimens of atacicept. Regimens include monthly and weekly dosing.
Interventions
DRUGAtacicept
Drug: Atacicept
Sponsors
Vera Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN | Up to 24 weeks | Gd-IgA1 levels through Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability of atacicept at different dosing regimensT | Baseline until end of study up to Week 24 | Incidence of treatment emergent reported Adverse Events (AE) |
| To evaluate the effect of atacicept on serum immunoglobulins (IgA) | 24 Weeks | IgA levels through Week 24 |
| To evaluate the effect of atacicept on serum immunoglobulins (IgG) | 24 Weeks | IgG levels through Week 24 |
| To evaluate the effect of atacicept on serum immunoglobulins (IgM) | 24 Weeks | IgM levels through Week 24 |
| To evaluate serum PK of atacicept | Baseline until end of study up to Week 24 | Serum concentration of atacicept |
Countries
United States
Contacts
STUDY_DIRECTORZeeshan Khawaja
Vice President, Clinical Development
Outcome results
None listed