Atacicept in Subjects With IgA Nephropathy (ORIGIN)

  • STATUS
    Recruiting
  • End date
    Jul 2, 2024
  • participants needed
    105
  • sponsor
    Vera Therapeutics, Inc.
Updated on 2 July 2022
treatment regimen
nephropathy
adrenaline
chronic kidney disease
proteinuria
mammogram

Summary

The objective of the study is to evaluate the effect of atacicept compared to placebo on change in proteinuria in adult subjects with IGAN.

Description

The study will assess multiple doses of atacicept vs. placebo on impact of renal function as measured by proteinuria. Safety, eGFR, serum immunoglobulins and gd-IgA1 will also be clinically assessed. The clinical study is comprised of a 36wk double-blind treatment period, followed by a 60wk open-label treatment period and a 26wk safety follow-up period.

Details
Condition IgA Nephropathy, Berger Disease
Treatment Atacicept, Placebo to match Atacicept
Clinical Study IdentifierNCT04716231
SponsorVera Therapeutics, Inc.
Last Modified on2 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Must have the ability to understand and sign a written informed consent form
Male or female of ≥18 years of age
Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
Total urine protein excretion >0.75g per 24-hour or urine protein to creatinine ratio (UPCR) >0.75 mg/mg based on a 24-hour urine sample during the Screening Period
eGFR ≥ 30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose
Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg

Exclusion Criteria

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
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 <30g/L in association with UPCR >3.5 mg/mg
Total urine protein excretion ≥ 5g per 24-hour or urine protein to creatinine ratio (UPCR) ≥ 5 mg/mg based on a 24-hour urine sample during the Screening Period
Renal or other organ transplantation prior to, or expected during the study
Concomitant chronic renal disease in addition to IgAN
Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening
History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test
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