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NCT06832410PHASE3Recruiting

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

Vertex Pharmaceuticals Incorporated

Start Date

3/31/2025

Completion Date

9/17/2027

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

Age Range: 18 years to 65 years

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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 Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

BIOLOGICAL

Biological/Vaccine

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Conditions

Type 1 DiabetesKidney Transplant

Locations

Perelman Center for Advanced Medicine - Endocrinology

Philadelphia, Pennsylvania 19104

United States

Montefiore Clinical and Translational Research Center - Endocrinology

Pittsburgh, Pennsylvania 15213

United States

UW University Hospital - Endocrinology

Madison, Wisconsin 53792

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