Primary outcomeCount of participants· 12 months after transplantation
Progression From Prediabetes to Diabetes
| Group | Value (Participants) |
|---|---|
| Exenatide SR Intervention Group | 0 |
| Standard of Care | 1 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataAssess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation
NCTNCT03961256 (opens ClinicalTrials.gov in a new tab)Other id19-000649
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 9 participants (actual)
- Sponsor
- Mayo Clinic · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 9 May 2019
- Primary completion
- 18 Oct 2021
- Completion
- 18 Oct 2021
- First posted
- 23 May 2019
- Last update posted
- 28 Oct 2022
- Conditions
- Pre Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2019202020212022
- Ph 2
Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation
NCT039612569 May 2019 to 18 Oct 2021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Exenatide SRDrug
Arms2
Experimental
Exenatide SR Intervention Group
Subjects will receive, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.
No intervention
Standard of Care
Subjects will receive standard post-transplant care as per Mayo Clinic usual practice.
Primary outcomes1
Outcomes the sponsor listed as primary.
Progression From Prediabetes to Diabetes
Time frame · 12 months after transplantation
Registry 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
Secondary outcomes(7)
Progression From Prediabetes to Diabetes
Time frame · 24 months after transplantation
Registry 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
Creatinine
Time frame · From enrollment, up to 20 months post-enrollment
Registry 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.
Hemoglobin A1c
Time frame · 12 and 24 months after kidney transplantation
Registry 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.
Incidence of Mesangial Expansion
Time frame · 12 and 24 months after kidney transplantation
Registry 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.
Incidence of Death
Time frame · From enrollment, up to 20 months post-enrollment
Registry description
Number of subjects to experience death by any cause
Graft Loss
Time frame · From enrollment, up to 20 months post-enrollment
Registry 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.
Adverse Events for Exenatide SR Intervention
Time frame · 12 months
Registry description
Total number of adverse events reported by the subjects that received the Exenatide SR Intervention
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeCount of participants· 24 months after transplantation
Progression From Prediabetes to Diabetes
| Group | Value (Participants) |
|---|---|
| Exenatide SR Intervention Group | 1 |
| Standard of Care | 1 |
Secondary outcomeMedian· From enrollment, up to 20 months post-enrollment
Creatinine
| Group | Value (mg/dL) |
|---|---|
| Exenatide SR Intervention Group | 1.7 |
| Standard of Care | 1.4 |
Secondary outcomeMedian· 12 and 24 months after kidney transplantation
Hemoglobin A1c
| Group | Value (percentage of glycated hemoglobin) |
|---|---|
| Exenatide SR Intervention Group | 5.6 |
| Standard of Care | 5.85 |
Secondary outcomeCount of participants· 12 and 24 months after kidney transplantation
Incidence of Mesangial Expansion
| Group | Value (Participants) |
|---|---|
| Exenatide SR Intervention Group | 0 |
| Standard of Care | 0 |
Secondary outcomeCount of participants· From enrollment, up to 20 months post-enrollment
Incidence of Death
| Group | Value (Participants) |
|---|---|
| Exenatide SR Intervention Group | 0 |
Secondary outcomeCount of participants· From enrollment, up to 20 months post-enrollment
Graft Loss
| Group | Value (Participants) |
|---|---|
| Exenatide SR Intervention Group | 0 |
Secondary outcomeNumber· 12 months
Adverse Events for Exenatide SR Intervention
| Group | Value (Adverse Events) |
|---|---|
| Exenatide SR Intervention Group | 10 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide SR Intervention GroupSubjects 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 | 0 / 6 | 0 / 6 | 4 / 6 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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