A Phase 3 interventional study of Povetacicept in Immunoglobulin A Nephropathy, sponsored by Vertex Pharmaceuticals Incorporated. Enrolling by invitation at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Vertex Pharmaceuticals Incorporated · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of povetacicept in participants with immunoglobulin A nephropathy (IgAN).
275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.
This study's planned enrollment of 605 is above the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.
Browse Glomerulonephritis, IGA studies →Vertex Pharmaceuticals Incorporated is the lead sponsor of 249 studies on the registry; 17 are open to participants now.
Of its 106 completed or terminated interventional studies of FDA-regulated products, 53 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
- Planned participation in another interventional, therapeutic clinical trial (other than the parent study).
Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Povetacicept every 4 weeks (Q4W) for 104 weeks.
Drug: Povetacicept
Subcutaneous injection administration.
Also known as: ALPN-303
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
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
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.
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
Kidney disease progression is defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death
Time frame: From Baseline through Week 104
Plan to share: 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/
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Povetacicept
Vertex Pharmaceuticals Incorporated →