We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Atacicept in Subjects With IgA Nephropathy (ORIGIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04716231
Recruitment Status : Active, not recruiting
First Posted : January 20, 2021
Last Update Posted : July 8, 2022
Sponsor:
Information provided by (Responsible Party):
Vera Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Berger Disease Biological: Atacicept Other: Placebo to match Atacicept Phase 2

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IGAN)
Actual Study Start Date : May 18, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : July 2024


Arm Intervention/treatment
Experimental: Atacicept Dose A
Atacicept Dose A once weekly subcutaneous (SC) injection
Biological: Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe
Other Name: VT-001

Experimental: Atacicept Dose B
Atacicept Dose B once weekly subcutaneous (SC) injection
Biological: Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe
Other Name: VT-001

Experimental: Atacicept Dose C
Atacicept C once weekly subcutaneous (SC) injection
Biological: Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe
Other Name: VT-001

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




Primary Outcome Measures :
  1. Change from baseline in urine protein to creatinine ratio (UPCR) [ Time Frame: 24 Weeks ]
    UPCR based on 24 hour urine collection


Secondary Outcome Measures :
  1. Change from baseline in urine protein to creatinine ratio (UPCR) [ Time Frame: 36 Weeks ]
    UPCR based on 24 hour urine collection


Other Outcome Measures:
  1. Change from baseline in urine protein to creatinine ratio (UPCR) [ Time Frame: 12, 48, 96 Weeks and Week 26 follow up ]
    UPCR based on 24 hour urine collection

  2. Change from baseline in estimated glomerular filtration rage (eGFR) [ Time Frame: 12, 24, 36, 48, 96 Weeks and 26 Week follow up ]
    eGFR calculated by CKD-EPI formula

  3. Change from baseline in IgA, IgG, IgM, C3, C4 and Gd-IgA1 levels [ Time Frame: 12, 24, 36, 48, 96 Weeks ]
    Serum measurement of IgA, IgG, IgM, C3, C4 and Gd-IgA1

  4. Number of participants with adverse events during the double-blind treatment period [ Time Frame: Through 36 Weeks ]
    Safety and tolerability

  5. Evaluate serum PK of atacicept [ Time Frame: Through study completion, an average of 2 years ]
    Serum concentration of atacicept



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Must have the ability to understand and sign a written informed consent form
  2. Male or female of ≥18 years of age
  3. Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
  4. 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
  5. eGFR ≥ 30 mL/min/1.73 m2, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  6. On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose
  7. Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg

Key Exclusion Criteria:

  1. 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
  2. Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% of eGFR within 3 months of screening)
  3. Evidence of nephrotic syndrome within 6 months of screening (serum albumin <30g/L in association with UPCR >3.5 mg/mg
  4. 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
  5. Renal or other organ transplantation prior to, or expected during the study
  6. Concomitant chronic renal disease in addition to IgAN
  7. Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening
  8. History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716231


Locations
Show Show 76 study locations
Sponsors and Collaborators
Vera Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Joanne Curley Chief Development Officer
Additional Information:
Layout table for additonal information
Responsible Party: Vera Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04716231    
Other Study ID Numbers: VT-001-0050
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: July 8, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vera Therapeutics, Inc.:
Berger Disease
Berger's Disease
IGA Glomerulonephritis
IGA Nephropathy
Iga Nephropathy 1
Immunoglobulin A Nephropathy Nephritis
IGA Type Nephropathy, IGA
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases