IgA Nephropathy Clinical Trial
— ORIGIN 3Official title:
A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IgAN)
NCT number | NCT04716231 |
Other study ID # | VT-001-0050 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 23, 2023 |
Est. completion date | July 2028 |
A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)
Status | Recruiting |
Enrollment | 376 |
Est. completion date | July 2028 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
United States | ORIGIN 3 Global Site Contact Information | Brisbane | California |
Lead Sponsor | Collaborator |
---|---|
Vera Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in urine protein to creatinine ratio (UPCR) | UPCR based on 24 hour urine collection | 36 Weeks | |
Secondary | Annualized rate of change in estimated glomerular filtration rate (eGFR) | eGFR calculated by CKD-EPI formula | 52 and 104 Weeks |
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