An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant

Last updated: August 20, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Prevention

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Treatment

Biological/Vaccine

Clinical Study ID

NCT06832410
VX23-880-102
EU CT number
  • Ages 18-65
  • All Genders

Study Summary

This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Clinical history of T1D with greater than or equal to (≥)5 years of insulindependence

  • Taking a stable immunosuppression regimen of tacrolimus and mycophenolate mofetil,mycophenolate sodium, or sirolimus for at least 4 weeks

  • Consistent use of continuous glucose monitor (CGM) for at least 4 weeks beforeScreening and willingness to use CGM for the duration of the study

Exclusion

Key Exclusion Criteria:

  • Prior islet cell transplant, organ transplant (other than kidney transplant), orcell therapy, except prior pancreatic graft that failed within the first 4 weeks

  • Participants had >1 kidney transplant procedure

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Biological/Vaccine
Phase: 3
Study Start date:
March 31, 2025
Estimated Completion Date:
September 17, 2027

Connect with a study center

  • Toronto General Hospital

    Toronto,
    Canada

    Active - Recruiting

  • Toronto General Hospital (TGH)

    Toronto,
    Canada

    Active - Recruiting

  • Toronto General Hospital - Endocrinology

    Toronto,
    Canada

    Active - Recruiting

  • Vancouver General Hospital

    Vancouver,
    Canada

    Active - Recruiting

  • Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre

    Vancouver,
    Canada

    Active - Recruiting

  • King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology

    Riyadh,
    Saudi Arabia

    Active - Recruiting

  • King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology

    Riyadh,
    Saudi Arabia

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Perelman Center for Advanced Medicine - Endocrinology

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Montefiore Clinical and Translational Research Center - Endocrinology

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center Montefiore

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • UW University Hospital - Endocrinology

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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