Recruiting NCT06832410
An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological/Vaccine.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes, Kidney Transplant. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of VX-880 in Subjects With Type 1 Diabetes With a Kidney Transplant
Overview
This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.
Interventions
- Biological Biological/Vaccine
Infused into the hepatic portal vein.
Primary outcome measures
- Proportion of Participants who are Insulin Independent [Time frame: At 1 year After VX-880 infusion]
Secondary outcome measures (4)
- Proportion of participants who achieve insulin independence and are insulin independent 12 months later [Time frame: 1 year after achieving insulin independence]
- Change from Baseline in glycosylated hemoglobin (HbA1c) [Time frame: Baseline, At 1 year After VX-880 infusion]
- Proportion of Participants who Maintain Insulin Independence for at least 1 year [Time frame: From VX-880 infusion to End of Study (up to 2 years)]
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: From Signing of informed consent to End of Study (up to 2 years)]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Perelman Center for Advanced Medicine - Endocrinology — Philadelphia
- Montefiore Clinical and Translational Research Center - Endocrinology — Pittsburgh
- UW University Hospital - Endocrinology — Madison
Canada · 2 centers
- Toronto General Hospital - Endocrinology — Toronto
- Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre — Vancouver
Saudi Arabia · 2 centers
- King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology — Riyadh
- King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology — Riyadh
Identifiers
NCT: NCT06832410 · VX23-880-102