Status:
RECRUITING
An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Type 1 Diabetes
Kidney Transplant
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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
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.
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 17 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06832410
Start Date
March 31 2025
End Date
September 17 2027
Last Update
March 23 2026
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Perelman Center for Advanced Medicine - Endocrinology
Philadelphia, Pennsylvania, United States, 19104
2
Montefiore Clinical and Translational Research Center - Endocrinology
Pittsburgh, Pennsylvania, United States, 15213
3
UW University Hospital - Endocrinology
Madison, Wisconsin, United States, 53792
4
Toronto General Hospital - Endocrinology
Toronto, Canada