Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility 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%).
- 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 ormedullary 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.
Criteria for Discontinuation of Medication:
- Decrease in renal function to eGFR to < 30 ml/min after study initiation.
- Decrease in eGFR by 50% on the 2 consecutive measurements without otherwise identified cause which maybe correctable (like high immunosuppressive medication level, rejection, urinary tract infection, etc.).
- Intolerable GI side effects despite the optimal therapy.
- Thyroid tumor.