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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04716231




Registration number
NCT04716231
Ethics application status
Date submitted
11/01/2021
Date registered
20/01/2021

Titles & IDs
Public title
Atacicept in Subjects with IgA Nephropathy
Scientific 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)
Secondary ID [1] 0 0
VT-001-0050
Universal Trial Number (UTN)
Trial acronym
ORIGIN 3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
IgA Nephropathy 0 0
Berger Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Atacicept
Other interventions - Placebo to match Atacicept

Experimental: Atacicept Dose 150mg - Atacicept 150mg once weekly subcutaneous (SC) injections

Placebo comparator: Placebo to match Atacicept (Part C/D) - Placebo to match Atacicept once weekly subcutaneous (SC) injection


Treatment: Other: Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe

Other interventions: Placebo to match Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in urine protein to creatinine ratio (UPCR)
Assessment method [1] 0 0
UPCR based on 24 hour urine collection
Timepoint [1] 0 0
36 Weeks
Secondary outcome [1] 0 0
Annualized rate of change in estimated glomerular filtration rate (eGFR)
Assessment method [1] 0 0
eGFR calculated by CKD-EPI formula
Timepoint [1] 0 0
52 and 104 Weeks

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2028
Actual
Sample size
Target
376
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vera Therapeutics, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Zeeshan Khawaja
Address 0 0
Vice President, Clinical Development
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vera Therapeutics, Inc. Clinical Trials Information
Address 0 0
Country 0 0
Phone 0 0
650-770-0077
Email 0 0
clinicaltrials@veratx.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04716231