An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant
A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of VX-880 in Subjects With Type 1 Diabetes With a Kidney Transplant
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests VX-880 in people with type 1 diabetes who have had a kidney transplant. It will check how well VX-880 works, how safe it is, and how well people handle the treatment.
This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have type 1 diabetes and have needed insulin for at least 5 years.
- Have taken a steady plan of medicines to prevent transplant rejection for at least 4 weeks: tacrolimus plus mycophenolate mofetil, mycophenolate sodium, or sirolimus.
- Have regularly used a continuous glucose monitor (CGM), a device that tracks blood sugar, for at least 4 weeks before screening. Be willing to use it throughout the study.
Who can't join
- Have had an islet cell transplant (cells that make insulin), cell therapy, or an organ transplant other than a kidney transplant. A past pancreas transplant is allowed if it failed within the first 4 weeks.
- Have had more than one kidney transplant procedure.
Simplified for readability. The official criteria below are what the study team uses.
Official 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, 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 sites (3)
PA
- Perelman Center for Advanced Medicine - Endocrinology · Philadelphia, PA 19104More trials in Philadelphia
- Montefiore Clinical and Translational Research Center - Endocrinology · Pittsburgh, PA 15213More trials in Pittsburgh
WI
- UW University Hospital - Endocrinology · Madison, WI 53792More trials in Madison