Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy
- Status
- TerminatedStopped: low recruitment
Results posted - Why it is watched
- non-weight indication: kidney
- Who it enrolls
- age 18 Years to no upper limit; BMI ≥40 required; conditions: CKD; Diabetic Kidney Disease; Type 2 Diabetes Mellitus in Obese; Obesity
- Interventions
- Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution; Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution
- Conditions
- CKD; Diabetic Kidney Disease; Type 2 Diabetes Mellitus in Obese; Obesity; Severe Obesity
- Phase and size
- Phase 3 · 15 participants
- Dates
- Start 2021-07-23
Primary completion 2023-01-31 - Sponsor
- Geisinger Clinic (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Kidney Transplant EligibilityAscertained at the end of 9 months
02Eligibility
Who can take part
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) or stage G3B/A2-3 CKD (eGFR 30 to \<45 ml/min/1.73m2 with albumin/creatinine ratio \>30 mg/g). 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
03Change log
Registry changes
No changes recorded since the trial was added.