Immunoglobulin A NephropathyPhase 3NCT07807995
A Phase 3 Open-Label Study of Long-term Treatment With Povetacicept in Adults With Immunoglobulin A Nephropathy
A Phase 3 study testing Povetacicept in people with Immunoglobulin A Nephropathy, run by Vertex Pharmaceuticals Incorporated at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of povetacicept in participants with immunoglobulin A nephropathy (IgAN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunoglobulin A Nephropathy
- What is being tested?
- Povetacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Sep 2026to 28 Dec 2029
- Phase
- Phase 3
- 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
- Completed the Week 104 visit in the parent study VX24-AIS-D08 (NCT06564142) and has not permanently discontinued study drug
- Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 15 milliliters per minute (mL/min)/1.73 square meter (m^2) within 45 days of Day 1 of this study
Who cannot join
- Planned participation in another interventional, therapeutic clinical trial (other than the parent study).
- Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Western Nephrology - Arvada
Arvada, Colorado, 80002
Prolato Clinical Research Center - Kirby Dr
Houston, Texas, 77054
Idaho Kidney Institute- Idaho Falls
Idaho Falls, Idaho, 83404
CTR Oakwater, LLC
Orlando, Florida, 32806
About this study
Official title: A Phase 3, Single-Arm, Open-Label Extension Study Evaluating the Long-Term Safety and Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of povetacicept in participants with immunoglobulin A nephropathy (IgAN).
- Conditions
- Immunoglobulin A Nephropathy
- Being tested
- Povetacicept
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PovetaciceptDrug
Also called ALPN-303
Subcutaneous injection administration.
| Study group | Role | What they receive |
|---|---|---|
| Povetacicept | Experimental | Participants will receive Povetacicept every 4 weeks (Q4W) for 104 weeks. Receives: Drug: Povetacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day 1 up to Week 112
Secondary outcomes (7)
Percentage Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR)
Measured: From Baseline through Week 104
Total Estimated Glomerular Filtration Rate (eGFR) Slope
Measured: From Baseline through Week 104
Change from Baseline in Galactose-deficient immunoglobulin A1 (Gd-IgA1)
Measured: From Baseline through Week 104
Percent Change from Baseline in Galactose-deficient immunoglobulin A1 (Gd-IgA1)
Measured: From Baseline through Week 104
Proportion of Participants Achieving Clinical Remission
Clinical remission is defined as UPCR less than (<)0.5 grams per gram (g/g), absence of hematuria, and eGFR decrease <25 percentage (%) from baseline.
Measured: From Baseline through Week 104
Proportion of Participants to Achieve Hematuria Resolution
Measured: From Baseline through Week 104
Time to Kidney Disease Progression
Kidney disease progression is defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death
Measured: From Baseline through Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start17 Sep 2026
- Primary completion28 Dec 2029 (estimated)
- Study completion28 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin A NephropathyStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 605 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807995
- Sponsor's protocol ID
- VX25-AIS-102
- Other IDs
- 2025-525064-14-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Single-Arm, Open-Label Extension Study Evaluating the Long-Term Safety and Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy
- ClinicalTrials.gov ID
- NCT07807995
- Acronym / sponsor ID
- VX25-AIS-102
- Conditions
- Immunoglobulin A Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 605 participants (estimated)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 28 Dec 2029 (estimated)
- Study completion
- 28 Dec 2029 (estimated)
- First posted
- 8 Sep 2026 (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 evaluate the long-term safety, tolerability and efficacy of povetacicept in participants with immunoglobulin A nephropathy (IgAN).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Povetacicept | Experimental | Drug: PovetaciceptParticipants will receive Povetacicept every 4 weeks (Q4W) for 104 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completed the Week 104 visit in the parent study VX24-AIS-D08 (NCT06564142) and has not permanently discontinued study drug
- Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 15 milliliters per minute (mL/min)/1.73 square meter (m^2) within 45 days of Day 1 of this study
Key exclusion criteria (2 listed)
- Planned participation in another interventional, therapeutic clinical trial (other than the parent study).
- Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| PovetaciceptAlso: ALPN-303Subcutaneous injection administration. | Drug | Povetacicept |
Primary outcome
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Week 112
7 secondary outcomes
Percentage Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR)
Time frame: From Baseline through Week 104
Total Estimated Glomerular Filtration Rate (eGFR) Slope
Time frame: From Baseline through Week 104
Change from Baseline in Galactose-deficient immunoglobulin A1 (Gd-IgA1)
Time frame: From Baseline through Week 104
Percent Change from Baseline in Galactose-deficient immunoglobulin A1 (Gd-IgA1)
Time frame: From Baseline through Week 104
Proportion of Participants Achieving Clinical Remission
Time frame: From Baseline through Week 104
Proportion of Participants to Achieve Hematuria Resolution
Time frame: From Baseline through Week 104
Time to Kidney Disease Progression
Time frame: From Baseline through Week 104
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 19 Oct 2026.
- Individual participant dataSharing planned: No. Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Povetacicept in people with Immunoglobulin A Nephropathy, run by Vertex Pharmaceuticals Incorporated at 4 sites 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 2 inclusion and 2 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From Day 1 up to Week 112). 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 19 Oct 2026.