An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant
Purpose
This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.
Conditions
- Type 1 Diabetes
- Kidney Transplant
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental VX-880 |
|
Recruiting Locations
Perelman Center for Advanced Medicine - Endocrinology
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Montefiore Clinical and Translational Research Center - Endocrinology
Pittsburgh 5206379, Pennsylvania 6254927 15213
Pittsburgh 5206379, Pennsylvania 6254927 15213
UW University Hospital - Endocrinology
Madison 5261457, Wisconsin 5279468 53792
Madison 5261457, Wisconsin 5279468 53792
More Details
- NCT ID
- NCT06832410
- Status
- Recruiting
- Sponsor
- Vertex Pharmaceuticals Incorporated