A Study to Evaluate the Effectiveness and Safety of Exenatide SR for Diabetes Prevention Following Kidney Transplantation

Overview

About this study

The purpose of this study is to compare the rate of progression from prediabetes at 4 months to frank diabetes at 12 months (as defined by increase in HbA1C or fasting BS to diabetic range based on the ADA criteria) after transplantation in kidney transplant recipients on Exenatide SR + SOC vs. standard-of-care alone.


 

Participation eligibility

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.

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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Open for enrollment

Contact information:

Nong Braaten L.P.N.

(507)538-9617

Braaten.Nong@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Contact us for the latest status

Contact information:

Joel Espinoza B.S.

(904)953-8855

Espinoza.Joel@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Contact us for the latest status

Contact information:

Sejal Patel B.S.

(480)342-2942

Patel.Sejal@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20458014

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