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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2023
Source Vera Therapeutics, Inc.
Contact Vera Therapeutics, Inc. Clinical Trials Information
Phone 650-770-0077
Email clinicaltrials@veratx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)


Description:

This is a multi-part study comprising of the original Phase 2b study (active, no longer recruiting) and the addition of a separate pivotal Phase 3 study (active, recruiting). After the completion of the primary results for the Ph 2b dose ranging study, the pivotal study (active, recruiting) will evaluate the efficacy and safety of atacicept compared to placebo in reducing proteinuria in subjects with IgAN and persistent proteinuria despite being on a maximally tolerated dose (MTD) of a RASi. Safety, eGFR, serum immunoglobulins and Gd-IgA1 will also be clinically assessed. The clinical study is comprised of a 104wk double-blind treatment period, followed by a 52wk open-label treatment period and a 26wk safety follow-up period. The UPCR primary endpoint will be assessed after the first 200 patients are randomized.


Recruitment information / eligibility

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

Study Design


Intervention

Biological:
Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe
Other:
Placebo to match Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe

Locations

Country Name City State
United States ORIGIN 3 Global Site Contact Information Brisbane California

Sponsors (1)

Lead Sponsor Collaborator
Vera Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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