RecruitingPhase 3NCT06832410

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

A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of VX-880 in Subjects With Type 1 Diabetes With a Kidney Transplant


Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

10 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • Clinical history of T1D with greater than or equal to (≥)5 years of insulin dependence
  • 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 before Screening and willingness to use CGM for the duration of the study

Exclusion Criteria2

  • Prior islet cell transplant, organ transplant (other than kidney transplant), or cell therapy, except prior pancreatic graft that failed within the first 4 weeks
  • Participants had \>1 kidney transplant procedure

Interventions

BIOLOGICALBiological/Vaccine

Infused into the hepatic portal vein.


Locations(7)

Perelman Center for Advanced Medicine - Endocrinology

Philadelphia, Pennsylvania, United States

Montefiore Clinical and Translational Research Center - Endocrinology

Pittsburgh, Pennsylvania, United States

UW University Hospital - Endocrinology

Madison, Wisconsin, United States

Toronto General Hospital - Endocrinology

Toronto, Canada

Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre

Vancouver, Canada

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

Riyadh, Saudi Arabia

King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology

Riyadh, Saudi Arabia

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NCT06832410


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