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Phase 3 Study of VX-880 Treatment for Adults with Type 1 Diabetes and a Kidney Transplant Evaluating Safety, Effectiveness, and Tolerability
Led by Vertex Pharmaceuticals Incorporated · Updated on 2026-03-23
10
Participants Needed
7
Research Sites
52 weeks
Total Duration
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
Research Team
M
Medical Information
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