Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03961256|
Recruitment Status : Active, not recruiting
First Posted : May 23, 2019
Last Update Posted : July 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pre Diabetes||Drug: Exenatide SR||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Exenatide SR 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.
- 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
- Rate of progression to diabetes [ Time Frame: By 24 months after transplantation ]To evaluate the rate of progression to diabetes
- Adverse Events [ Time Frame: By 24 months after transplantation ]Number of adverse events reported
- 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
- 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
- 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
- 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
- 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
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
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Mark D Stegall||Mayo Clinic|