Kidney Transplant, Type 1 Diabetes
Conditions
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.
Interventions
BIOLOGICALBiological/Vaccine
Infused into the hepatic portal vein.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants who are Insulin Independent | At 1 year After VX-880 infusion |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants who achieve insulin independence and are insulin independent 12 months later | 1 year after achieving insulin independence |
| Change from Baseline in glycosylated hemoglobin (HbA1c) | Baseline, At 1 year After VX-880 infusion |
| Proportion of Participants who Maintain Insulin Independence for at least 1 year | From VX-880 infusion to End of Study (up to 2 years) |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Signing of informed consent to End of Study (up to 2 years) |
Countries
Canada, Saudi Arabia, United States
Contacts
CONTACTMedical Information
Outcome results
None listed