IgA Nephropathy (IgAN)Phase 2NCT07020923
Monthly Dosing of Atacicept in IgAN
A Phase 2 study testing Atacicept in people with IgA Nephropathy (IgAN) and Berger Disease, run by Vera Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy (IgAN), Berger Disease
- What is being tested?
- Atacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2025to Sep 2027
- 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 years and older
- 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
- Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provides written informed consent prior to performing any study assessments
- Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
- Total urine protein excretion ≥0.75 g per 24-hour or urine protein-to-creatinine ratio (UPCR) ≥0.75 mg/mg based on a 24-hour urine sample
- eGFR ≥30 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
- On a stable prescribed regimen of RASi (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker) for at least 8 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1
Who cannot join
- IgAN secondary to another condition (eg, liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (ie, Henoch-Schonlein purpura), systemic lupus erythematosus, 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 <3.0 g/dL in association with UPCR >3.5 mg/mg)
- Renal or other organ transplantation prior to or expected during the study, with the exception of corneal transplants
- Concomitant chronic renal disease in addition to IgAN (eg, diabetic nephropathy, primary focal segmental glomerulosclerosis, membranous nephropathy, C3 glomerulopathy, lupus nephritis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients With IgAN
This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept
Read the detailed description
This Phase 2 study is to explore the effectiveness, safety and tolerability of different dosing regimens of atacicept. Regimens include monthly and weekly dosing.
- Conditions
- IgA Nephropathy (IgAN), Berger Disease
- Being tested
- Atacicept
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtaciceptDrug
Also called VT-001
Drug: Atacicept
| Study group | Role | What they receive |
|---|---|---|
| Atacicept Arm 1 | Experimental | Atacicept dose A administered subcutaneous (sc) injection monthly Receives: Drug: Atacicept |
| Atacicept Arm 2 | Experimental | Atacicept dose B administered subcutaneous (sc) injection monthly |
| Atacicept Arm 3 | Experimental | Atacicept dose C administered subcutaneous (sc) injection monthly |
| Atacicept Arm 4 | Experimental | Atacicept dose D administered subcutaneous (sc) injection weekly |
| Atacicept Arm 5 | Experimental | Atacicept dose E administered subcutaneous (sc) injection weekly for 24 weeks, followed by monthly sc injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN
Gd-IgA1 levels through Week 24
Measured: Up to 24 weeks
Secondary outcomes (5)
To evaluate the safety and tolerability of atacicept at different dosing regimensT
Incidence of treatment emergent reported Adverse Events (AE)
Measured: Baseline until end of study up to Week 24
To evaluate the effect of atacicept on serum immunoglobulins (IgA)
IgA levels through Week 24
Measured: 24 Weeks
To evaluate the effect of atacicept on serum immunoglobulins (IgG)
IgG levels through Week 24
Measured: 24 Weeks
To evaluate the effect of atacicept on serum immunoglobulins (IgM)
IgM levels through Week 24
Measured: 24 Weeks
To evaluate serum PK of atacicept
Serum concentration of atacicept
Measured: Baseline until end of study up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start29 May 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zeeshan Khawaja, Study director, Vice President, Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020923
- Sponsor's protocol ID
- VT-001-0020
- Status last verified
- Apr 2026
- First submitted
- 13 May 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients With IgAN
- ClinicalTrials.gov ID
- NCT07020923
- Acronym / sponsor ID
- VT-001-0020
- Conditions
- IgA Nephropathy (IgAN), Berger Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Vera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Jun 2025 (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.
This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept
Detailed description
This Phase 2 study is to explore the effectiveness, safety and tolerability of different dosing regimens of atacicept. Regimens include monthly and weekly dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Atacicept Arm 1 | Experimental | Drug: AtaciceptAtacicept dose A administered subcutaneous (sc) injection monthly |
| Atacicept Arm 2 | Experimental | –Atacicept dose B administered subcutaneous (sc) injection monthly |
| Atacicept Arm 3 | Experimental | –Atacicept dose C administered subcutaneous (sc) injection monthly |
| Atacicept Arm 4 | Experimental | –Atacicept dose D administered subcutaneous (sc) injection weekly |
| Atacicept Arm 5 | Experimental | –Atacicept dose E administered subcutaneous (sc) injection weekly for 24 weeks, followed by monthly sc injections |
Who may qualify
- Ages
- 18 years and older
- 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
- Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provides written informed consent prior to performing any study assessments
- Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years
- Total urine protein excretion ≥0.75 g per 24-hour or urine protein-to-creatinine ratio (UPCR) ≥0.75 mg/mg based on a 24-hour urine sample
- eGFR ≥30 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Key exclusion criteria (5 listed)
- IgAN secondary to another condition (eg, liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (ie, Henoch-Schonlein purpura), systemic lupus erythematosus, 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 <3.0 g/dL in association with UPCR >3.5 mg/mg)
- Renal or other organ transplantation prior to or expected during the study, with the exception of corneal transplants
- Concomitant chronic renal disease in addition to IgAN (eg, diabetic nephropathy, primary focal segmental glomerulosclerosis, membranous nephropathy, C3 glomerulopathy, lupus nephritis)
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 |
|---|---|---|
| AtaciceptAlso: VT-001Drug: Atacicept | Drug | Atacicept Arm 1 |
Primary outcome
Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN
Time frame: Up to 24 weeks
Gd-IgA1 levels through Week 24
5 secondary outcomes
To evaluate the safety and tolerability of atacicept at different dosing regimensT
Time frame: Baseline until end of study up to Week 24
To evaluate the effect of atacicept on serum immunoglobulins (IgA)
Time frame: 24 Weeks
To evaluate the effect of atacicept on serum immunoglobulins (IgG)
Time frame: 24 Weeks
To evaluate the effect of atacicept on serum immunoglobulins (IgM)
Time frame: 24 Weeks
To evaluate serum PK of atacicept
Time frame: Baseline until end of study up to Week 24
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 13 Apr 2026.
- Vera Therapeutics, Inc Company WebsiteLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Zeeshan Khawaja study director
Vice President, 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 in people with IgA Nephropathy (IgAN) and Berger Disease, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 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?
Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN (time frame: Up to 24 weeks). 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 13 Apr 2026.