Using semaglutide to manage high blood sugar after kidney transplants

Safety and Efficacy of Oral Semaglutide in Hyperglycaemic Patients After Renal Transplantation

This study is testing if semaglutide can help manage high blood sugar in people who have recently had a kidney transplant, while also looking at its effects on weight and kidney function.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Rigshospitalet, Denmark (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Copenhagen)
• Trial ID: NCT05702931 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of semaglutide, a glucose-lowering medication, in managing hyperglycemia in patients who have recently undergone renal transplantation. The study compares semaglutide to a placebo, both administered alongside standard insulin treatment, to determine if semaglutide can effectively regulate plasma glucose levels without the common side effects associated with insulin. Additionally, the trial aims to assess the impact of semaglutide on renal graft function, weight management, and overall safety in this patient population. The study is designed to provide insights into the potential benefits of semaglutide for improving post-transplant outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who develop hyperglycemia 10 to 15 days after renal transplantation.

Not a fit: Patients with type 1 diabetes, severe immunological risks, or those with certain gastrointestinal or malignancy conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could reduce the reliance on insulin and its associated side effects for kidney transplant recipients experiencing hyperglycemia.

How similar studies have performed: While the use of semaglutide has shown promise in other diabetic populations, its application in renal transplant recipients is novel and untested.

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 40 days after transplantation: Fasting plasma glucose ≥ 7.0 mmol/L or an oral glucose tolerance test with at plasma glucose ≥ 11.1 mmol/L or Pre-transplant type 2 diabetes: Receiving glucose-lowring treatment prior to kidney transplantation
4. An eGFR \> 15 ml/min/1.73 m2 10 to 40 days after renal transplantation
5. Subject must be willing and able to comply with trial protocol

Exclusion Criteria:

1. Type 1 diabetes
2. Dialysis
3. High risk immunological transplantation (not including ABO-incompatible or re-transplantation)
4. Early graft rejection (all rejections verified by biopsy, except borderline rejections. Study initiations can begin 5 days after last dose of rejection treatment with methylprednisolone)
5. Chronic pancreatitis/previous acute pancreatitis
6. Known or suspected hypersensitivity to trial or related products
7. Use of DPP-4 inhibitors within five days prior to screening
8. Use of GLP-1RA within 10 days prior to screening
9. Malignancy (except basal cell carcinoma)
10. Inflammatory bowel disease
11. Previous bowel resection
12. 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
13. Any acute condition or exacerbation of chronic condition that would in the investigator's opinion interfere with the initial trial visit schedule and procedures.
14. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant, or are not using adequate contraceptive methods
15. Impaired liver function (plasma ALAT \> two times upper reference levels)
16. Elevated amylase (plasma amylase \> two times upper reference levels)
17. Untreated proliferative diabetic retinopathy, untreated diabetic macular edema or active conditions of this type that are not under therapeutic control according
18. Any condition that clinically significantly impairs the observation of the fundus or anterior chamber

Where this trial is running

Copenhagen

• Department og Nephrology and Endocrinology, Rigshospitalet — Copenhagen, Denmark (Recruiting)

Study contacts

• Study coordinator: Tobias Bomholt, MD, PhD

Conditions Hyperglycemia; Renal Transplant Complication Primary Non-Function; Diabetes