Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07807995

A Phase 3 Open-Label Study of Long-term Treatment With 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).

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Immunoglobulin A Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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:

  • Planned participation in another interventional, therapeutic clinical trial (other than the parent study).

Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Povetacicept

Drug

Subcutaneous injection administration.

Other names: ALPN-303

Primary outcomes

  1. 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

Secondary outcomes

  1. Percentage Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR)

    Time frame: From Baseline through Week 104

  2. Total Estimated Glomerular Filtration Rate (eGFR) Slope

    Time frame: From Baseline through Week 104

  3. Change from Baseline in Galactose-deficient immunoglobulin A1 (Gd-IgA1)

    Time frame: From Baseline through Week 104

  4. Percent Change from Baseline in Galactose-deficient immunoglobulin A1 (Gd-IgA1)

    Time frame: From Baseline through Week 104

  5. Proportion of Participants Achieving Clinical Remission

    Time frame: From Baseline through Week 104

    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.

  6. Proportion of Participants to Achieve Hematuria Resolution

    Time frame: From Baseline through Week 104

  7. Time to Kidney Disease Progression

    Time frame: From Baseline through Week 104

    Kidney disease progression is defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information

CONTACT

[email protected]

617-341-6777

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.