Clinical trial NCT03961256: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pre Diabetes
Keywords: Kidney Transplant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression From Prediabetes to Diabetes
timeFrame: 12 months after transplantation
Secondary outcomes:
measure: Progression From Prediabetes to Diabetes
timeFrame: 24 months after transplantation
measure: Creatinine
timeFrame: From enrollment, up to 20 months post-enrollment
measure: Hemoglobin A1c
timeFrame: 12 and 24 months after kidney transplantation
measure: Incidence of Mesangial Expansion
timeFrame: 12 and 24 months after kidney transplantation
measure: Incidence of Death
timeFrame: From enrollment, up to 20 months post-enrollment
measure: Graft Loss
timeFrame: From enrollment, up to 20 months post-enrollment
measure: Adverse Events for Exenatide SR Intervention
timeFrame: 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark D Stegall
role: PRINCIPAL_INVESTIGATOR
References: