Type 1 DiabetesPhase 3NCT06832410
An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant
A Phase 3 study testing Biological/Vaccine in people with Type 1 Diabetes and Kidney Transplant, run by Vertex Pharmaceuticals Incorporated at 7 sites in 3 countries.
Trial summary
This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, Kidney Transplant
- What is being tested?
- Biological/Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 31 Mar 2025to 17 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
United States3 sites, 3 recruiting
- Recruiting
UW University Hospital - Endocrinology
Madison, Wisconsin, 53792
- Recruiting
Perelman Center for Advanced Medicine - Endocrinology
Philadelphia, Pennsylvania, 19104
- Recruiting
Montefiore Clinical and Translational Research Center - Endocrinology
Pittsburgh, Pennsylvania, 15213
Canada2 sites, 2 recruiting
- Recruiting
Toronto General Hospital - Endocrinology
Toronto
- Recruiting
Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre
Vancouver
Saudi Arabia2 sites, 2 recruiting
- Recruiting
King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology
Riyadh
- Recruiting
King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology
Riyadh
About this study
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
This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.
- Conditions
- Type 1 Diabetes, Kidney Transplant
- Being tested
- Biological/Vaccine
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological/VaccineBiological
Also called Zimislecel, Formerly known as STx-02
Infused into the hepatic portal vein.
| Study group | Role | What they receive |
|---|---|---|
| VX-880 | Experimental | Not described Receives: Biological: Biological/Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants who are Insulin Independent
Measured: At 1 year After VX-880 infusion
Secondary outcomes (4)
Proportion of participants who achieve insulin independence and are insulin independent 12 months later
Measured: 1 year after achieving insulin independence
Change from Baseline in glycosylated hemoglobin (HbA1c)
Measured: Baseline, At 1 year After VX-880 infusion
Proportion of Participants who Maintain Insulin Independence for at least 1 year
Measured: 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)
Measured: From Signing of informed consent to End of Study (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start31 Mar 2025
- Primary completion17 Sep 2026 (estimated)
- Study completion17 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832410
- Sponsor's protocol ID
- VX23-880-102
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06832410
- Acronym / sponsor ID
- VX23-880-102
- Conditions
- Type 1 Diabetes, Kidney Transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 17 Sep 2026 (estimated)
- Study completion
- 17 Sep 2027 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VX-880 | Experimental | Biological: Biological/Vaccine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological/VaccineAlso: Zimislecel, Formerly known as STx-02Infused into the hepatic portal vein. | Biological | VX-880 |
Primary outcome
Proportion of Participants who are Insulin Independent
Time frame: At 1 year After VX-880 infusion
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No. Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biological/Vaccine in people with Type 1 Diabetes and Kidney Transplant, run by Vertex Pharmaceuticals Incorporated at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Information (617-341-6777, medicalinfo@vrtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants who are Insulin Independent (time frame: At 1 year After VX-880 infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.