Semaglutide Treatment for Hyperglycaemia After Renal Transplantation

Launched by RIGSHOSPITALET, DENMARK · Jan 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called semaglutide (also known as Rybelsus) on patients who experience high blood sugar (hyperglycemia) after receiving a kidney transplant. High blood sugar can happen often in the first couple of weeks after surgery, and the usual treatment involves insulin, which can sometimes cause low blood sugar and weight gain. The trial will compare semaglutide to a placebo (a non-active pill) to see if it can effectively help control blood sugar levels without the same risks.

To be eligible for this study, participants need to be between 18 and 80 years old and diagnosed with high blood sugar within 10 to 15 days after their kidney transplant. They must have certain kidney function levels and be able to follow the study guidelines. Those who join will take semaglutide or a placebo for 14 weeks while still receiving their usual diabetes treatments. Throughout the trial, participants will have regular check-ins with medical staff to monitor their health and adjust treatments as needed. This study is important because it could provide new insights into managing blood sugar levels for kidney transplant patients safely and effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent obtained before any trial-related procedures are performed
• • 2. Male or female; age: 18-80 years
• • 3. Diagnosis of post-transplant hyperglycaemia 10 to 15 days after transplantation: Fasting plasma glucose ≥ 7.0 mmol/L or an oral glucose tolerance test with at plasma glucose ≥ 11.1 mmol/L
• • 4. An eGFR \> 15 ml/min/1.73 m2 10 to 15 days after renal transplantation
• • 5. Subject must be willing and able to comply with trial protocol
• Exclusion Criteria:
• • 1. Type 1 diabetes
• • 2. Type 2 diabetes pre-transplant (except HbA1c ≤ 55mmol/mol and lifestyle-treated)
• • 3. Dialysis
• • 4. High risk immunological transplantation (not including ABO-incompatible or re-transplantation)
• • 5. Early graft rejection Sema-RTx study
• • 6. Chronic pancreatitis/previous acute pancreatitis
• • 7. Known or suspected hypersensitivity to trial or related products
• • 8. Use of DPP-4 inhibitors within five days prior to screening
• • 9. Use of GLP-1RA within 10 days prior to screening
• • 10. Malignancy (except basal cell carcinoma)
• • 11. Inflammatory bowel disease
• • 12. Previous bowel resection
• • 13. Cardiac disease defined as decompensated heart failure (New York Heart Association class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last six months
• • 14. Any acute condition or exacerbation of chronic condition that would in the investigator's opinion interfere with the initial trial visit schedule and procedures.
• • 15. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant, or are not using adequate contraceptive methods
• • 16. Impaired liver function (plasma ALAT \> two times upper reference levels)
• • 17. Elevated amylase (plasma amylase \> two times upper reference levels)