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Completed

NCT Number: NCT03961256

Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation

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.

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Key information

Conditions

Pre Diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exenatide SR

Drug

Exenatide SR 2 mg subcutaneous (SQ) weekly

Primary outcomes

  1. Progression From Prediabetes to Diabetes

    Time frame: 12 months after transplantation

    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

  1. Progression From Prediabetes to Diabetes

    Time frame: 24 months after transplantation

    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

  2. Creatinine

    Time frame: From enrollment, up to 20 months post-enrollment

    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.

  3. Hemoglobin A1c

    Time frame: 12 and 24 months after kidney transplantation

    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.

  4. Incidence of Mesangial Expansion

    Time frame: 12 and 24 months after kidney transplantation

    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.

  5. Incidence of Death

    Time frame: From enrollment, up to 20 months post-enrollment

    Number of subjects to experience death by any cause

  6. Graft Loss

    Time frame: From enrollment, up to 20 months post-enrollment

    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.

  7. Adverse Events for Exenatide SR Intervention

    Time frame: 12 months

    Total number of adverse events reported by the subjects that received the Exenatide SR Intervention

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 23, 2019
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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