Recruiting

Phase 3

VX-880An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT06832410

Conditions

Type 1 Diabetes

Kidney Transplant

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Biological/Vaccine

Study Details

Brief summary:

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

Study ID

NCT06832410

Start date

Mar 31, 2025

Status verified date

Mar, 2026

Completion date

Sep 17, 2027

Anticipated

Primary completion date

Sep 17, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VX-880

Interventions

Biological/Vaccine

Infused into the hepatic portal vein.

Primary outcome measure

Proportion of Participants who are Insulin Independent [ Time Frame: At 1 year After VX-880 infusion ]

Central Contacts and Locations

Central contacts

Medical Information

617-341-6777 medicalinfo@vrtx.com

Locations

Perelman Center for Advanced Medicine - Endocrinology

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Montefiore Clinical and Translational Research Center - Endocrinology

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

UW University Hospital - Endocrinology

Recruiting

Madison, Wisconsin, United States, 53792

Toronto General Hospital - Endocrinology

Recruiting

Toronto, Canada

Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre

Recruiting

Vancouver, Canada

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-03-23.