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

Launched by VERTEX PHARMACEUTICALS INCORPORATED · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called VX-880 for people with Type 1 Diabetes who have also received a kidney transplant. The main goals of the study are to see how well VX-880 works, how safe it is, and how well patients can tolerate it. The trial is currently looking for participants, specifically individuals aged between 18 and 74 who have been dependent on insulin for at least 5 years and are taking certain stable medications to help prevent their body from rejecting the kidney.

To participate, individuals must have been using a continuous glucose monitor (a device that tracks blood sugar levels) for at least 4 weeks before joining the study and be willing to continue using it throughout the trial. However, people who have had prior organ transplants (other than a kidney) or multiple kidney transplants are not eligible. If you or a loved one meets these criteria, participating in this trial could provide an opportunity to contribute to important research while potentially benefiting from a new treatment for managing diabetes after a kidney transplant.

Gender

ALL

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
• • Participants had greater than (\>)1 kidney transplant procedure
• • Other protocol defined Inclusion/Exclusion criteria may apply.