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Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT03961256
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Stegall, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Pre Diabetes Drug: Exenatide SR Phase 2

Detailed Description:

New diabetes can develop after transplant and may affect a transplanted kidney's health and a recipient's overall health. Currently, patients who are pre-diabetic are encouraged to exercise and lose weight. Researchers are planning to test whether an addition of this medication will lead to better results and more effectively prevent diabetes in patients who already have high blood sugars.

Exenatide SR is medication given by weekly injection. It increases insulin release in response to a meal and slows digestion. This medicine is already in use and approved by the US Food and Drug Administration (FDA) in patients with diabetes. However, it has not been approved for this indication; the FDA has allowed the use of this drug in this research study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Prospective, Randomized, Multicenter, Open-Label, Controlled Trial to Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation.
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : April 22, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Experimental: Intervention Group
Subjects will receive, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.
Drug: Exenatide SR
Exenatide SR 2 mg subcutaneous (SQ) weekly

No Intervention: Standard of Care
Subjects will receive standard post-transplant care as per Mayo Clinic usual practice.



Primary Outcome Measures :
  1. Rate of progression from prediabetes to diabetes [ Time Frame: 4 months to 6 months ]
    Number of subjects to have an increase in HbA1C or fasting blood sugar to diabetic range based on the American Diabetes Association (ADA) criteria after kidney transplantation


Secondary Outcome Measures :
  1. Rate of progression to diabetes [ Time Frame: By 24 months after transplantation ]
    To evaluate the rate of progression to diabetes

  2. Adverse Events [ Time Frame: By 24 months after transplantation ]
    Number of adverse events reported

  3. Incidence of mesangial expansion [ Time Frame: 12 and 24 months after kidney transplantation ]
    To compare the incidence of mesangial expansion >20% in patients treated with Exenatide SR + SOC vs. SOC alone

  4. Hemoglobin A1c levels in patients treated with Exenatide SR + SOC vs. SOC alone [ Time Frame: 12 and 24 months after kidney transplantation ]
    To compare hemoglobin A1c levels in patients treated with Exenatide SR + SOC vs. SOC alone

  5. Transplant Kidney Function [ Time Frame: From enrollment, up to 20 months post-enrollment ]
    To compare transplant kidney function in the two arms as measured by creatinine levels and eGFR calculations

  6. Incidence of death [ Time Frame: From enrollment, up to 20 months post-enrollment ]
    To compare the incidence of death by any cause in the two arms

  7. Graft Loss [ Time Frame: From enrollment, up to 20 months post-enrollment ]
    To compare the incidence of graft loss by any cause in the two arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961256


Contacts
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Contact: Nong Yowe Braaten (507) 538-9617 braaten.nong@mayo.edu
Contact: Leah Majerus (507) 255-3940 majerus.leah@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Nong Yowe Braaten    507-538-9617    Braaten.Nong@mayo.edu   
Contact: Leah Majerus    507-255-3940    Majerus.Leah@mayo.edu   
Principal Investigator: Mark D Stegall, M.D.         
Sub-Investigator: Aleksandra Kukla, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Mark D Stegall Mayo Clinic

Additional Information:
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Responsible Party: Mark Stegall, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03961256     History of Changes
Other Study ID Numbers: 19-000649
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Plan pending.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mark Stegall, Mayo Clinic:
Kidney Transplant

Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists