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
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/