Clinical Trials in the USA / NCT04716231
Active, not recruiting
Phase 3
Atacicept in Subjects With IgA Nephropathy
NCT04716231 · tracked via the Priya Life Science USA tracker
Condition(s) studied
IgA NephropathyBerger Disease
Investigational drug(s) / intervention(s)
Atacicept →Placebo to match Atacicept
Atacicept: Once weekly subcutaneous (SC) injections by prefilled syringe
Placebo to match Atacicept: Once weekly subcutaneous (SC) injections by prefilled syringe
Study summary
A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)
Eligibility
Key Inclusion Criteria:
* Must have the ability to understand and sign a written informed consent form
* Male or female of ≥18 years of age
* Total urine protein excretion ≥1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) ≥1.0 mg/mg based on a 24-hour urine sample during the Screening Period
* Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
* 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 at Screening
* Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg
Key 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
* 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
* 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
* 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
* Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept
Primary outcome measure(s)
- Percentage Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) — 36 Weeks
Percentage reduction in UPCR was obtained from geometric mean ratios. The natural log-transformed ratio of UPCR to its baseline value was analyzed using a Mixed Model for Repeated Measures (MMRM), adjusted by baseline variables specified in the Statistical Analysis Plan (SAP), including data from baseline up to Week 36 during the Double-Blind period.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| ORIGIN 3 Global Site Contact Information | Brisbane | California |
More Vera Therapeutics, Inc. trials in the USA
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Other trials for the same condition
Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy
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Phase 2b Open-Label Repeat Kidney Biopsy Study
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A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04716231 on ClinicalTrials.gov ↗ ← All trials in the USA