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

NCT06832410 · Vertex Pharmaceuticals Incorporated
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Official title
A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of VX-880 in Subjects With Type 1 Diabetes With a Kidney Transplant
About this study
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
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.
Study design
Enrollment target: 10 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-31
Estimated completion: 2027-09-17
Last updated: 2026-03-23
Interventions
Biological: Biological/Vaccine
Primary outcomes
  • Proportion of Participants who are Insulin Independent (At 1 year After VX-880 infusion)
Sponsor
Vertex Pharmaceuticals Incorporated · industry
Contacts & investigators
ContactMedical Information · contact · medicalinfo@vrtx.com · 617-341-6777
All locations (7)
Perelman Center for Advanced Medicine - EndocrinologyRecruiting
Philadelphia, Pennsylvania, United States
Montefiore Clinical and Translational Research Center - EndocrinologyRecruiting
Pittsburgh, Pennsylvania, United States
UW University Hospital - EndocrinologyRecruiting
Madison, Wisconsin, United States
Toronto General Hospital - EndocrinologyRecruiting
Toronto, Canada
Vancouver General Hospital - Gordon and Leslie Diamond Health Care CentreRecruiting
Vancouver, Canada
King Abdullah International Medical Research Center (KAIMRC) - Riyadh - EndocrinologyRecruiting
Riyadh, Saudi Arabia
King Faisal Specialist Hospital & Research Centre - Riyadh - EndocrinologyRecruiting
Riyadh, Saudi Arabia