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