IgA Nephropathy (IgAN)Phase 2ORIGIN EXTENDNCT06674577
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept
A Phase 2 study testing Atacicept 150 mg in people with IgA Nephropathy (IgAN) and Renal and Urinary Disorders, run by Vera Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to collect long-term safety and tolerability data for atacicept in patients with IgAN that completed Vera trial investigating atacicept in IgAN population. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- IgA Nephropathy (IgAN), Renal and Urinary Disorders, Berger Disease
- What is being tested?
- Atacicept 150 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 21 May 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments
- Completed the protocol-defined treatment period on treatment in a parent study of atacicept in patients with IgAN
- For Atacicept Drug Holiday Group only: Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90mmHg at screening and Day 1
- A participant who was assigned female at birth is eligible if not pregnant (ie, after a confirmed menstrual period, a negative serum pregnancy test at screening and has a negative urine pregnancy test at Day 1), is not breastfeeding (for at least three months prior to screening), and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP) OR
- Is a WOCBP who agrees to use a highly effective contraceptive method (ie, has a failure rate of less than 1% per year) at least 7 days prior to enrollment, through 175 days after the last dose of study drug.
Who cannot join
- Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)
- For Atacicept Drug Holiday Group only: History of splenectomy
- Known hypersensitivity to atacicept or any component of the formulated atacicept
- For Atacicept Drug Holiday Group only: Major surgery within 6 weeks prior to screening or planned/expected major surgery during the study period (including the safety follow-up period). Major surgery often involves opening one of the major body cavities (abdomen or chest) and/or use of general anesthesia. Types of surgery that have the highest risk include heart or lung, liver, abdomen, or major operations on the bones and joints (eg, hip replacement)
- Clinically significant history of alcohol or drug abuse in the 1 year prior to Day 1 as per Investigator opinion
- Unwillingness or lack of capacity to follow all study procedures
Show all 21Show fewer
- For Atacicept Drug Holiday Group only: Treatment with other investigational agents within the last 4 weeks or 5 half-lives, whichever is longer, prior to screening
- Evidence of nephrotic syndrome (serum albumin <30g/L in association with UPCR >3.5 mg/mg) within 6 months of screening
- Currently on chronic dialysis, or expected to initiate dialysis within 12 weeks of screening
- Renal or other organ transplantation prior to, or expected during, the study, with the exception of corneal transplants
- Clinically significant or predefined abnormalities per central laboratory tests at screening, meeting any of the criteria: Clinical evidence of immunosuppression and/or hypogammaglobulinemia as determined by the Investigator.
- For Atacicept Drug Holiday Group only: Aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level >2.5 × upper limit of normal (ULN) or total bilirubin >1.5 x ULN. If the participant has a known history of Gilberts (history of isolated increase in total bilirubin without increase in liver transaminases), contact the Medical Monitor for further discussion.
- For Atacicept Drug Holiday Group only: Administration of live and live-attenuated vaccinations within 30 days prior to enrollment.
- For Atacicept Drug Holiday Group only: History or current diagnosis of any demyelinating disease such as, but not restricted to, multiple sclerosis (MS) or optic neuritis (ON)
- Active clinically significant viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks prior to enrollment, or completion of oral anti-infectives within 2 weeks prior to enrollment, ora history of recurrent infections (ie, 3 or more of the same type of infection in a 12-month rolling period). Vaginal candidiasis, onychomycosis and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled are not exclusionary.
- Atacicept Drug Holiday Group only: If the participant is undergoing current treatment for latent tuberculosis infection (LTBI), they must have received at least 4 continuous weeks of an appropriate LTBI treatment prior to screening without evidence of re-exposure to be eligible for this study. If on LTBI treatment at the Screening visit, the participant will be expected to complete an appropriate LTBI treatment regimen to remain in the trial
- Prohibited medications:
- Use of systemic corticosteroids (including oral budesonide) or immunosuppressive medications (eg, MMF, azathioprine, cyclophosphamide, hydroxychloroquine) for the treatment of IgAN within 2 months prior to Screening
- For glucocorticosteroids (GCS), "Systemic" is defined as oral, rectal or injectable (intravenous or intramuscular) routes of administration, Other routes of administration are allowed, including intra-articular, inhaled, topical, ophthalmic, optic and intranasal
- Use of B-cell-directed biologic therapies including belimumab, rituximab, ocrelizumab within 12 months of screening
- Use of other biologics (eg, anti-TNF, abatacept, anti-IL-6) and investigational biologics for the treatment of IgAN within 6 months of screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept
The purpose of this study is to collect long-term safety and tolerability data for atacicept in patients with IgAN that completed Vera trial investigating atacicept in IgAN population.
Read the detailed description
Eligible participants will receive atacicept 150 mg once weekly (QW) self-administered subcutaneously (SC). Participants will be grouped by whether they are restarting atacicept after cessation in the parent study (Group 1: Atacicept Drug Holiday) or are continuing atacicept with no disruption in treatment (Group 2: Continuous Atacicept Treatment). Long-term safety and tolerability of atacicept is assessed by routine clinical and laboratory tests and adverse events.
- Being tested
- Atacicept 150 mg
- Keywords
- IGA Glomerulonephritis, IGA Nephropathy, Iga Nephropathy 1, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA, renal and urinary disorders, Berger Disease, Berger's Disease
- Medical subject headings
- Glomerulonephritis, IGA, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atacicept 150 mgDrug
The atacicept drug product is available as a ready to use injection solution in the following prefilled syringe (PFS) that is composed of: *BD Hypak™ SCF™ Barrel Glass barrel 1ml long with staked needle 27G ½" 5B with Rigid Needle Shield BD260 *BD SCF™ Stopper 1ml long W4023 Flurotec
| Study group | Role | What they receive |
|---|---|---|
| Atacicept 150mg once weekly subcutaneous (SC) injection | Experimental | Other Names:
VT-001 Receives: Drug: Atacicept 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events observed during the dosing period
Patient incidence of reported Adverse Events (AEs)
Measured: Baseline until end of study up to week156
Secondary outcomes (4)
To evaluate the effect of atacicept on change in proteinuria
Changes in proteinuria based on UPCR (Urine Protein Creatinine Ratio) and UACR (Urine Albumin-Creatinine Ratio) on spot urine.
Measured: Baseline until end of study up to week156
To evaluate the effect of atacicept on the change in estimated glomerular filtration rate (eGFR) using serum creatinine and cystatin C, respectively
Changes in estimated glomerular filtration rate (eGFR) based on serum creatinine and cystatain C, respectively
Measured: Baseline until end of study up to week156
To evaluate the effect of atacicept on hematuria
Hematuria level based on blood on urine dipstick
Measured: Baseline until end of study up to week156
To evaluate the effect of atacicept on serum galactose-deficient IgA1 (Gd-IgA1) levels
Changes in serum Gd-IgA1 levels
Measured: Baseline until end of study up to week156
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Dec 2024
- Primary completion21 May 2031 (estimated)
- Study completion21 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Michael, MD, Study director, Senior Director, Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674577
- Sponsor's protocol ID
- VT-001-0051
- Acronym
- ORIGIN EXTEND
- Status last verified
- Jun 2026
- First submitted
- 3 Oct 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept
- ClinicalTrials.gov ID
- NCT06674577
- Acronym / sponsor ID
- ORIGIN EXTEND / VT-001-0051
- Keywords
- IGA Glomerulonephritis, IGA Nephropathy, Iga Nephropathy 1, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA, renal and urinary disorders, Berger Disease, Berger's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Vera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 21 May 2031 (estimated)
- Study completion
- 21 May 2031 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect long-term safety and tolerability data for atacicept in patients with IgAN that completed Vera trial investigating atacicept in IgAN population.
Detailed description
Eligible participants will receive atacicept 150 mg once weekly (QW) self-administered subcutaneously (SC). Participants will be grouped by whether they are restarting atacicept after cessation in the parent study (Group 1: Atacicept Drug Holiday) or are continuing atacicept with no disruption in treatment (Group 2: Continuous Atacicept Treatment). Long-term safety and tolerability of atacicept is assessed by routine clinical and laboratory tests and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| Atacicept 150mg once weekly subcutaneous (SC) injection | Experimental | Drug: Atacicept 150 mgOther Names: VT-001 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments
- Completed the protocol-defined treatment period on treatment in a parent study of atacicept in patients with IgAN
- For Atacicept Drug Holiday Group only: Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90mmHg at screening and Day 1
- A participant who was assigned female at birth is eligible if not pregnant (ie, after a confirmed menstrual period, a negative serum pregnancy test at screening and has a negative urine pregnancy test at Day 1), is not breastfeeding (for at least three months prior to screening), and at least one of the following conditions applies:
Key exclusion criteria (21 listed)
- Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)
- For Atacicept Drug Holiday Group only: History of splenectomy
- Known hypersensitivity to atacicept or any component of the formulated atacicept
- For Atacicept Drug Holiday Group only: Major surgery within 6 weeks prior to screening or planned/expected major surgery during the study period (including the safety follow-up period). Major surgery often involves opening one of the major body cavities (abdomen or chest) and/or use of general anesthesia. Types of surgery that have the highest risk include heart or lung, liver, abdomen, or major operations on the bones and joints (eg, hip replacement)
- Clinically significant history of alcohol or drug abuse in the 1 year prior to Day 1 as per Investigator opinion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atacicept 150 mgThe atacicept drug product is available as a ready to use injection solution in the following prefilled syringe (PFS) that is composed of: *BD Hypak™ SCF™ Barrel Glass barrel 1ml long with staked needle 27G ½" 5B with Rigid Needle Shield BD260 *BD SCF™ Stopper 1ml long W4023 Flurotec | Drug | Atacicept 150mg once weekly subcutaneous (SC) injection |
Primary outcome
Incidence of adverse events observed during the dosing period
Time frame: Baseline until end of study up to week156
Patient incidence of reported Adverse Events (AEs)
4 secondary outcomes
To evaluate the effect of atacicept on change in proteinuria
Time frame: Baseline until end of study up to week156
To evaluate the effect of atacicept on the change in estimated glomerular filtration rate (eGFR) using serum creatinine and cystatin C, respectively
Time frame: Baseline until end of study up to week156
To evaluate the effect of atacicept on hematuria
Time frame: Baseline until end of study up to week156
To evaluate the effect of atacicept on serum galactose-deficient IgA1 (Gd-IgA1) levels
Time frame: Baseline until end of study up to week156
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Vera Therapeutics, Inc Company WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Michael, MD study director
Senior Director, Clinical Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atacicept 150 mg in people with IgA Nephropathy (IgAN) and Renal and Urinary Disorders, run by Vera Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events observed during the dosing period (time frame: Baseline until end of study up to week156). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.