Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide SR Intervention Group | Experimental | Subjects will receive, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. |
|
| Standard of Care | No Intervention | Subjects will receive standard post-transplant care as per Mayo Clinic usual practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide SR | Drug | Exenatide SR 2 mg subcutaneous (SQ) weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months after transplantation |
| Creatinine |
Not provided
Inclusion criteria:
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:
Hypersensitivity to Exenatide
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark D Stegall | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide SR Intervention Group | Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly |
| FG001 | Standard of Care | Subjects received standard post-transplant care as per Mayo Clinic usual practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide SR Intervention Group | Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly |
| BG001 | Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 12 months after transplantation |
|
Deaths were assessed up to 20 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 12 months.
Deaths and Adverse Events collected for the Exenatide SR Intervention Group only. Deaths and Adverse Events were not collected for the Standard of Care arm
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exenatide SR Intervention Group | Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark D. Stegall, M.D. | Mayo Clinic | 507-266-2812 | Stegall.Mark@mayo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2020 | Sep 30, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| From enrollment, up to 20 months post-enrollment |
| 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. | 12 and 24 months after kidney transplantation |
| 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. | 12 and 24 months after kidney transplantation |
| Incidence of Death | Number of subjects to experience death by any cause | From enrollment, up to 20 months post-enrollment |
| 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. | From enrollment, up to 20 months post-enrollment |
| Adverse Events for Exenatide SR Intervention | Total number of adverse events reported by the subjects that received the Exenatide SR Intervention | 12 months |
Subjects received standard post-transplant care as per Mayo Clinic usual practice.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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 | Data was not collected nor analyzed for one subject in the standard of care arm | Posted | Count of Participants | Participants | 24 months after transplantation |
|
|
|
| Secondary | 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. | Data was not collected nor analyzed for one subject in the standard of care arm | Posted | Median | Inter-Quartile Range | mg/dL | From enrollment, up to 20 months post-enrollment |
|
|
|
| Secondary | 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. | Data was not collected nor analyzed for one subject in the standard of care arm | Posted | Median | Inter-Quartile Range | percentage of glycated hemoglobin | 12 and 24 months after kidney transplantation |
|
|
|
| Secondary | 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. | Data was not collected nor analyzed for one subject in the standard of care arm at 24 months | Posted | Count of Participants | Participants | 12 and 24 months after kidney transplantation |
|
|
|
| Secondary | Incidence of Death | Number of subjects to experience death by any cause | Deaths collected for the Exenatide SR Intervention Group only. Deaths were not collected for the Standard of Care arm | Posted | Count of Participants | Participants | From enrollment, up to 20 months post-enrollment |
|
|
|
| Secondary | 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. | Graft loss collected for the Exenatide SR Intervention Group only. Graft Loss was not collected for the Standard of Care arm | Posted | Count of Participants | Participants | From enrollment, up to 20 months post-enrollment |
|
|
|
| Secondary | Adverse Events for Exenatide SR Intervention | Total number of adverse events reported by the subjects that received the Exenatide SR Intervention | Posted | Number | Adverse Events | 12 months |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 4 |
| 6 |
| Vomiting | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | General disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| 24 months |
|
|