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

Last updated: April 23, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes And Hypertension

Diabetes Prevention

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) or celltherapy

  • Participants had greater than (>)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

  • Vancouver General Hospital

    Vancouver,
    Canada

    Active - Recruiting

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