Back to resultsAssess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation
Primary Purpose
Pre Diabetes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exenatide SR
Sponsored by
About this trial
This is an interventional treatment trial for Pre Diabetes focused on measuring Kidney Transplant
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 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exenatide SR Intervention Group
Standard of Care
Arm Description
Subjects will receive, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.
Subjects will receive standard post-transplant care as per Mayo Clinic usual practice.
Outcomes
Primary Outcome Measures
Progression From Prediabetes to Diabetes
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
Progression From Prediabetes to Diabetes
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
Creatinine
A creatinine blood test measures the level of creatinine in the blood. Creatinine is a waste product that forms when creatine, which is found in the muscle, breaks down. Creatinine levels in the blood can provide the doctors with information about how well the kidneys are working. As measured in mg/dL units.
Hemoglobin A1c
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal.
Incidence of Mesangial Expansion
Number of subjects to experience mesangial expansion >20%. Mesangial expansion occurs due to increased deposition of extracellular matrix proteins, for example fibronectin, into the mesangium. Accumulation of extracellular matrix proteins then occurs due to insufficient degradation by matrix metalloproteinases.
Incidence of Death
Number of subjects to experience death by any cause
Graft Loss
The number of subjects to experience graft loss. Primary graft failure is defined as no evidence of engraftment or hematological recovery of donor cells, within the first month after transplant, without evidence of disease relapse. Secondary graft failure refers to the loss of a previously functioning graft, resulting in cytopenia involving at least two blood cell lineages.
Adverse Events for Exenatide SR Intervention
Total number of adverse events reported by the subjects that received the Exenatide SR Intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03961256
Brief Title
Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
October 18, 2021 (Actual)
Study Completion Date
October 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes
Keywords
Kidney Transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exenatide SR Intervention Group
Arm Type
Experimental
Arm Description
Subjects will receive, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Subjects will receive standard post-transplant care as per Mayo Clinic usual practice.
Intervention Type
Drug
Intervention Name(s)
Exenatide SR
Intervention Description
Exenatide SR 2 mg subcutaneous (SQ) weekly
Primary Outcome Measure Information:
Title
Progression From Prediabetes to Diabetes
Description
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
Time Frame
12 months after transplantation
Secondary Outcome Measure Information:
Title
Progression From Prediabetes to Diabetes
Description
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
Time Frame
24 months after transplantation
Title
Creatinine
Description
A creatinine blood test measures the level of creatinine in the blood. Creatinine is a waste product that forms when creatine, which is found in the muscle, breaks down. Creatinine levels in the blood can provide the doctors with information about how well the kidneys are working. As measured in mg/dL units.
Time Frame
From enrollment, up to 20 months post-enrollment
Title
Hemoglobin A1c
Description
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal.
Time Frame
12 and 24 months after kidney transplantation
Title
Incidence of Mesangial Expansion
Description
Number of subjects to experience mesangial expansion >20%. Mesangial expansion occurs due to increased deposition of extracellular matrix proteins, for example fibronectin, into the mesangium. Accumulation of extracellular matrix proteins then occurs due to insufficient degradation by matrix metalloproteinases.
Time Frame
12 and 24 months after kidney transplantation
Title
Incidence of Death
Description
Number of subjects to experience death by any cause
Time Frame
From enrollment, up to 20 months post-enrollment
Title
Graft Loss
Description
The number of subjects to experience graft loss. Primary graft failure is defined as no evidence of engraftment or hematological recovery of donor cells, within the first month after transplant, without evidence of disease relapse. Secondary graft failure refers to the loss of a previously functioning graft, resulting in cytopenia involving at least two blood cell lineages.
Time Frame
From enrollment, up to 20 months post-enrollment
Title
Adverse Events for Exenatide SR Intervention
Description
Total number of adverse events reported by the subjects that received the Exenatide SR Intervention
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D Stegall
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation
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