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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVertex Pharmaceuticals Incorporated

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biological/Vaccine

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

7
Canada
Toronto General Hospital - Endocrinology Toronto Canada
Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre Vancouver Canada
Saudi Arabia
King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology Riyadh Saudi Arabia
King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology Riyadh Saudi Arabia

Sponsors and collaborators

Vertex Pharmaceuticals Incorporated

Lead sponsor