Evaluating VX-880 for Type 1 Diabetes in Kidney Transplant Patients
A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of VX-880 in Subjects With Type 1 Diabetes With a Kidney Transplant
PHASE3 · Vertex Pharmaceuticals Incorporated · NCT06832410
This study is testing if a new treatment called VX-880 can help people with Type 1 Diabetes who have had a kidney transplant manage their blood sugar better.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vertex Pharmaceuticals Incorporated (industry) |
| Locations | 7 sites (Philadelphia, Pennsylvania and 6 other locations) |
| Trial ID | NCT06832410 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy, safety, and tolerability of VX-880 in individuals with Type 1 Diabetes who have undergone a kidney transplant. Participants must have a history of insulin dependence for at least five years and be on a stable immunosuppression regimen. The study will involve the use of continuous glucose monitoring to track participants' glucose levels throughout the trial. The goal is to determine how well VX-880 can manage diabetes in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals with Type 1 Diabetes who have received a kidney transplant and are on a stable immunosuppression regimen.
Not a fit: Patients who have had prior islet cell transplants or multiple kidney transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve diabetes management and overall health outcomes for kidney transplant recipients with Type 1 Diabetes.
How similar studies have performed: While this approach is novel in the context of kidney transplant patients with Type 1 Diabetes, similar studies have shown promise in other populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Philadelphia, Pennsylvania and 6 other locations
- Perelman Center for Advanced Medicine - Endocrinology — Philadelphia, Pennsylvania, United States (RECRUITING)
- Montefiore Clinical and Translational Research Center - Endocrinology — Pittsburgh, Pennsylvania, United States (RECRUITING)
- UW University Hospital - Endocrinology — Madison, Wisconsin, United States (RECRUITING)
- Toronto General Hospital - Endocrinology — Toronto, Canada (RECRUITING)
- Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre — Vancouver, Canada (RECRUITING)
- King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology — Riyadh, Saudi Arabia (RECRUITING)
- King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology — Riyadh, Saudi Arabia (RECRUITING)
Study contacts
- Study coordinator: Medical Information
- Email: medicalinfo@vrtx.com
- Phone: 617-341-6777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, Kidney Transplant