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

NCT03961256 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 19-000649
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre Diabetes

Keywords

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Progression From Prediabetes to Diabetes

  24 months after transplantation

• Creatinine

  From enrollment, up to 20 months post-enrollment

• Hemoglobin A1c

  12 and 24 months after kidney transplantation

• Incidence of Mesangial Expansion

  12 and 24 months after kidney transplantation

• Incidence of Death

  From enrollment, up to 20 months post-enrollment

Study Arms (2)

Exenatide SR Intervention Group

EXPERIMENTAL

Subjects will receive, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months.

Drug: Exenatide SR

Standard of Care

NO INTERVENTION

Subjects will receive standard post-transplant care as per Mayo Clinic usual practice.

Interventions

Exenatide SR DRUG

Exenatide SR 2 mg subcutaneous (SQ) weekly

Exenatide SR Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Mark D. Stegall, M.D.
• Organization: Mayo Clinic

Stegall.Mark@mayo.edu

507-266-2812

Study Officials

• Mark D Stegall

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 23, 2019
• Study Start: May 9, 2019
• Primary Completion: October 18, 2021
• Study Completion: October 18, 2021
• Last Updated: October 28, 2022
• Results First Posted: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)