Actively Recruiting
A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of VX-880 in Subjects With Type 1 Diabetes With a Kidney Transplant
Led by Vertex Pharmaceuticals Incorporated · Updated on 2026-03-23
10
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, safety, and tolerability of VX-880 in adults aged 18 to 65 who have Type 1 Diabetes and have received a kidney transplant. The study focuses on participants who have been insulin-dependent for at least 5 years and are on a stable immunosuppression regimen. This phase 3 clinical trial aims to understand how VX-880 impacts insulin independence and blood sugar control in this specific group. Participants will receive VX-880, a biological treatment infused into the hepatic portal vein. The study will monitor the proportion of participants who become insulin independent one year after the infusion. Secondary measures include maintaining insulin independence for at least one year, changes in glycosylated hemoglobin (HbA1c) levels, and tracking any adverse events throughout the study, which may last up to two years. During the study, participants will use a continuous glucose monitor (CGM) before and throughout the trial to track blood sugar levels consistently. Researchers will assess insulin independence, safety, and tolerability by observing adverse events and changes in blood sugar control. The study involves regular visits and monitoring over a period extending to two years to evaluate long-term outcomes and treatment effects.
CONDITIONS
Brief Title
An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical history of Type 1 Diabetes with 5 or more 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 during the study
- Age between 18 and 65 years
You will not qualify if you...
- Prior islet cell transplant, organ transplant other than kidney transplant, or cell therapy, except a pancreatic graft that failed within the first 4 weeks
- More than one kidney transplant procedure
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive an infusion of VX-880 into the hepatic portal vein as part of the treatment for Type 1 Diabetes following kidney transplant.
Regular visits for monitoring during treatment up to 2 years
Trial Site Locations
Total: 7 locations
1
Perelman Center for Advanced Medicine - Endocrinology
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
2
Montefiore Clinical and Translational Research Center - Endocrinology
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
3
UW University Hospital - Endocrinology
Madison, Wisconsin, United States, 53792
Actively Recruiting
4
Toronto General Hospital - Endocrinology
Toronto, Canada
Actively Recruiting
5
Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre
Vancouver, Canada
Actively Recruiting
6
King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology
Riyadh, Saudi Arabia
Actively Recruiting
7
King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology
Riyadh, Saudi Arabia
Actively Recruiting
Research Team
M
Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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