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

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 19-000649
    Sponsor Protocol Number: 19-000649

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.

See eligibility 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 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

(507)538-9617

Braaten.Nong@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available