Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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 chronic kidney disease (CKD) or dialysis-dependent end-stage kidney disease (ESKD) on patients' eligibility for kidney transplantation at the end of 9 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Geisinger Clinic
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. - Age ≥ 18 years

2. - BMI 25-45 kg/m2

3. - T2DM

4. - Advanced CKD* (last eGFR <30 ml/min/1.73m2 in EHR or ESKD on dialysis prior to screening)

5. - 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].

6. - Ability to provide informed consent before any trial-related activities

7. - 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)

1. - Active malignancy

2. - History of pancreatitis

3. - Active substance abuse

4. - Severe COPD

5. - Pulmonary fibrosis

6. - Symptomatic angina or recent myocardial infarction within 6 months

7. - Severe peripheral vascular disease

8. - Cirrhosis

9. - New York Health Association (NYHA) Class III-IV congestive heart failure

10. - Severe cognitive impairment

11. - Drug addiction

12. - History of non-adherence to therapy

13. - Active infection

14. - Expected life expectancy < 5 years

Additional exclusion criteria

15. - Type 1 diabetes mellitus

16. - History of diabetic ketoacidosis within the last 12 months

17. - Planning on undergoing bariatric surgery in next 9 months.

18. - Pregnant, breast-feeding, or planned pregnancy prior to the end of participation or not using adequate contraceptive measures

19. - Self-reported average consumption of > 21 alcoholic beverages per week or binge drinking

20. - Psychiatric hospitalization in past year

21. - Principal investigator discretion (i.e. concerns about safety, compliance)

22. - Known or suspected allergy to trial medication

23. - Previous participation (i.e. randomized) in this trial

24. - Use of GLP1-RA or pramlintide within 90 days prior to screening

25. - Use of metformin (contraindicated with eGFR < 30 ml/min/1.73m2)

26. - Use of DPP-4 inhibitors within 30 days prior to screening

27. - Personal or family history of medullary thyroid cancer, multiple endocrine neoplasia types 2A and 2B syndrome

28. - Last hemoglobin A1c ≥ 12% or A1c <6% (to avoid risk of hypoglycemia) prior to screening