ENvarsus for Impaired Glucose Tolerance Post REnal transplAnT

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Our hypothesis is that switching from the current standard of care twice daily Adoport (Tacrolimus) to once daily Envarsus (tacrolimus) in patients who have impaired glucose tolerance post-transplant will lead to an improvement in their glucose tolerance, and may reduce the subsequent incidence of PTDM.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barts & The London NHS Trust
• Treatments: Tacrolimus

Criteria

Inclusion Criteria

1. Females or males aged 18 years and above

2. Having undergone renal transplantation within the previous 2 years

3. Current treatment with tacrolimus

4. Evidence of impaired glucose tolerance (defined as a blood glucose level between 7.8-11.1 mmol/L after a two hour oral glucose tolerance test)

5. Provision of written, informed consent prior to any study specific procedures

Exclusion Criteria

1. Unable to consent

2. Planning on becoming pregnant/unwilling to use highly effective contraception during the 3-month treatment period or breastfeeding.

3. Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease

4. History of Type 1 or Type 2 diabetes mellitus; or on treatment with anti-diabetic medications

5. Prior therapy with Envarsus

6. Exposure to an investigational drug withing the preceding 3 months, or 5 half-lives whichever is greater.