Overview

Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation

Status:
Active, not recruiting
Trial end date:
2022-01-01
Target enrollment:
0
Participant gender:
All
Summary
Researchers are trying to determine if an anti-diabetes medication, called Exenatide SR, is well tolerated in kidney transplant patients with elevated blood glucose levels, and if it's effective in preventing diabetes.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Treatments:
Exenatide
Criteria
Inclusion criteria:

- Recipients of solitary kidney transplants (i.e. not combined liver-kidney,
pancreas-kidney etc.)

- At 4 months after transplantation: Prediabetes (fasting blood glucose 100-125 mg/dl;
or 2 hr glucose 140-199 or HgbA1c 5.7-6.4%)

Exclusion criteria:

- Diabetes pre-transplantation

- Diabetes at 4 months

- <18 years of age

- eGFR <30 ml/min (estimated by MDRD equation from serum creatinine)

- Active acute cellular rejection including borderline (If treated and resolved, these
patients can be included)

- BK nephropathy active

- History of pancreatitis, pre-existing moderate-to-severe gastroparesis, liver
cirrhosis or family /personal history of multiple endocrine neoplasia 2 or medullary
thyroid cancer

- Pregnant or breastfeeding women. Female Subject must be either:

- Of non-child bearing potential: Post-menopausal (defined as at least 1 year
without any menses) prior to screening , or documented surgically sterile or
status post-hysterectomy

- Or if childbearing potential, agree not to try and become pregnant during the
study for at least 90 days after the final study drug administration. And have a
negative serum or urine pregnancy test. And if heterosexually active, agree to
consistently use two forms of highly effective birth control.

- Hypersensitivity to Exenatide