Ensayos clínicos

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 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.
• Pancreatitis.
• Hypoglycemia.