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Status:

TERMINATED

Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy

Lead Sponsor:

Geisinger Clinic

Conditions:

CKD

Diabetic Kidney Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

This randomized study evaluates the effect of subcutaneous semaglutide /in combination with lifestyle counseling in patients with type 2 diabetes mellitus (T2DM), overweight/obesity, and stage 4-5 chr...

Detailed Description

Transplant policies regarding listing consider uncontrolled diabetes and severe obesity to be contraindications though there is great variability for exact BMI (35-45 kg/m2) and A1c (9-10%) thresholds...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • \- Age ≥ 18 years
  • \- BMI 25-45 kg/m2
  • \- T2DM
  • \- Advanced CKD\* (last eGFR \<30 ml/min/1.73m2 in EHR or ESKD on dialysis prior to screening) or stage G3B/A2-3 CKD (eGFR 30 to \<45 ml/min/1.73m2 with albumin/creatinine ratio \>30 mg/g).
  • \- Fulfill kidney transplant listing criteria except for one or more of the following reasons (1: uncontrolled diabetes \[A1c ≥9%); 2: severe obesity (BMI ≥ 40 kg/m2 or BMI 35-40 kg/m2 with waist circumference \>120 cm). See exclusion criteria for general contraindications used for transplant listing used by majority of U.S. transplant centers\].
  • \- Ability to provide informed consent before any trial-related activities
  • \- Access to a telephone
  • The cause of the CKD does not need to be due specifically to diabetes
  • Exclusion Criteria (General contraindications used for transplant listing used by majority of U.S. transplant centers)
  • \- Active malignancy
  • \- History of pancreatitis
  • \- Active substance abuse
  • \- Severe COPD
  • \- Pulmonary fibrosis
  • \- Symptomatic angina or recent myocardial infarction within 6 months
  • \- Severe peripheral vascular disease
  • \- Cirrhosis
  • \- New York Health Association (NYHA) Class III-IV congestive heart failure
  • \- Severe cognitive impairment
  • \- Drug addiction
  • \- History of non-adherence to therapy
  • \- Active infection
  • \- Expected life expectancy \< 5 years
  • Additional exclusion criteria
  • \- Type 1 diabetes mellitus
  • \- History of diabetic ketoacidosis within the last 12 months
  • \- Planning on undergoing bariatric surgery in next 9 months.
  • \- Pregnant, breast-feeding, or planned pregnancy prior to the end of participation or not using adequate contraceptive measures
  • \- Self-reported average consumption of \> 21 alcoholic beverages per week or binge drinking
  • \- Psychiatric hospitalization in past year
  • \- Principal investigator discretion (i.e. concerns about safety, compliance)
  • \- Known or suspected allergy to trial medication
  • \- Previous participation (i.e. randomized) in this trial
  • \- Use of GLP1-RA or pramlintide within 90 days prior to screening
  • \- Use of metformin (contraindicated with eGFR \< 30 ml/min/1.73m2)
  • \- Use of DPP-4 inhibitors within 30 days prior to screening
  • \- Personal or family history of medullary thyroid cancer, multiple endocrine neoplasia types 2A and 2B syndrome
  • \- Last hemoglobin A1c ≥ 12% or A1c \<6% (to avoid risk of hypoglycemia) prior to screening

Exclusion

    Key Trial Info

    Start Date :

    July 23 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 31 2023

    Estimated Enrollment :

    15 Patients enrolled

    Trial Details

    Trial ID

    NCT04741074

    Start Date

    July 23 2021

    End Date

    January 31 2023

    Last Update

    February 9 2024

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Geisinger Medical Center

    Danville, Pennsylvania, United States, 17821

    2

    Geisinger Wyoming Valley

    Wilkes-Barre, Pennsylvania, United States, 18702