Atacicept in Subjects With IgA Nephropathy (ORIGIN)
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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 |
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Recruitment Status :
Active, not recruiting
First Posted : January 20, 2021
Last Update Posted : February 9, 2023
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Sponsor:
Vera Therapeutics, Inc.
Information provided by (Responsible Party):
Vera Therapeutics, Inc.
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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 |
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.
| 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 : | March 2023 |
| Estimated Study Completion Date : | July 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Atacicept Dose A
Atacicept Dose A once weekly subcutaneous (SC) injection
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Biological: Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe
Other Name: VT-001 |
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Experimental: Atacicept Dose B
Atacicept Dose B once weekly subcutaneous (SC) injection
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Biological: Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe
Other Name: VT-001 |
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Experimental: Atacicept Dose C
Atacicept C once weekly subcutaneous (SC) injection
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Biological: Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe
Other Name: VT-001 |
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Placebo Comparator: Placebo to match Atacicept
Placebo to match Atacicept once weekly subcutaneous (SC) injection
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Other: Placebo to match Atacicept
Once weekly subcutaneous (SC) injections by prefilled syringe |
Primary Outcome Measures :
- Change from baseline in urine protein to creatinine ratio (UPCR) [ Time Frame: 24 Weeks ]UPCR based on 24 hour urine collection
Secondary Outcome Measures :
- Change from baseline in urine protein to creatinine ratio (UPCR) [ Time Frame: 36 Weeks ]UPCR based on 24 hour urine collection
Other Outcome Measures:
- 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
- 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
- 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
- Number of participants with adverse events during the double-blind treatment period [ Time Frame: Through 36 Weeks ]Safety and tolerability
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Must have the ability to understand and sign a written informed consent form
- Male or female of ≥18 years of age
- Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
- 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
- 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
- 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
- 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
- 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
- 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
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 76 study locations
Sponsors and Collaborators
Vera Therapeutics, Inc.
Investigators
| Study Director: | Joanne Curley | Chief Development Officer |
Additional 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: | February 9, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Vera Therapeutics, Inc.:
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Berger Disease Berger's Disease IGA Glomerulonephritis IGA Nephropathy |
Iga Nephropathy 1 Immunoglobulin A Nephropathy Nephritis IGA Type Nephropathy, IGA |
Additional relevant MeSH terms:
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Kidney Diseases Glomerulonephritis, IGA Urologic Diseases Glomerulonephritis |
Nephritis Autoimmune Diseases Immune System Diseases |