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
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