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)
Enter a location and click search to find clinical trials sorted by distance.
1
Geisinger Medical Center
Danville, Pennsylvania, United States, 17821
2
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18702