VX-880 for Type 1 Diabetes with Kidney Transplant
Biological/Vaccine
Autoimmune Diseases+5
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 1
Treatment Study
Summary
Study start date: March 31, 2025
Actual date on which the first participant was enrolled.This clinical trial is focused on testing a medication called VX-880 for people who have Type 1 Diabetes and have also had a kidney transplant. The aim of this study is to find out if VX-880 can safely and effectively help manage diabetes in this specific group of people. Type 1 Diabetes is a condition where the body can't produce insulin, a hormone that helps control blood sugar levels. For those who have had a kidney transplant, managing diabetes is even more crucial, and this study hopes to provide a new treatment option that could improve their quality of life. Participants in the study will receive the VX-880 treatment, and researchers will monitor its effects on their diabetes. The treatment method and exact procedures are not detailed, but typical clinical trials involve regular health check-ups and monitoring. The study will assess not only how well the drug works in controlling blood sugar but also look at its safety and how well participants tolerate it. As with any clinical trial, there may be potential risks, but the study aims to ensure the treatment is safe before it is considered for wider use.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Perelman Center for Advanced Medicine - Endocrinology
Philadelphia, United StatesOpen Perelman Center for Advanced Medicine - Endocrinology in Google MapsMontefiore Clinical and Translational Research Center - Endocrinology
Pittsburgh, United StatesUW University Hospital - Endocrinology
Madison, United StatesToronto General Hospital - Endocrinology
Toronto, Canada