Semaglutide Treatment for Hyperglycaemia After Renal Transplantation
Status:
Not yet recruiting
Trial end date:
2026-04-01
Target enrollment:
Participant gender:
Summary
Background: Post-transplant hyperglycaemia occurs frequently in renal transplant recipients
within the first two weeks after transplantation. Standard-of-care is primarily based on
insulin treatment with the adherent risk of hypoglycaemia and weight gain. Semaglutide
produces an effective lowering of plasma glucose in diabetes patients with chronic kidney
disease (CKD) and leads to a reduction in weight and the incidence of hypoglycaemia. The
efficacy of semaglutide is untested in renal transplant recipients, and safety concerns
remain, primarily on renal graft function.
Objectives: The primary objective is to establish whether subcutaneous semaglutide (Ozempic)
compared with placebo, both as add-on to standard-of-care, is non-inferior in regulating
plasma glucose in patients with hyperglycaemia after renal transplantation. Secondary
objectives aim to evaluate the effect of subcutaneous semaglutide on renal graft function,
weight, use of insulin, cardiovascular parameters and safety parameters (plasma semaglutide
concentration, gastrointestinal side effects, dose of immunosuppressants).
Design: An investigator-initiated, placebo-controlled, double-blinded, parallel-group,
randomised trial.
Population: Patients (n = 104) with post-transplant hyperglycaemia and an estimated
glomerular filtration rate (eGFR) > 15 ml/min/1.73 m2.
Methods: Participants diagnosed with post-transplant hyperglycaemia, 10 to 15 days
post-transplant, will be randomised 1:1 to either 14 weeks of subcutaneous once-weekly
semaglutide or placebo both as add-on to standard glucose-lowering therapy. Participants will
maintain weekly contact with the clinic during the first five weeks and at two to four weeks
intervals during the remaining study period. During the trial, each patient will be monitored
according to blood laboratory values with safety assessed at every visit by a nephrologist.
Pre-prandial plasma glucose will be measured in the morning and evening to adjust
glucose-lowering therapy after consultation with an endocrinologist. Double blinded
continuous glucose monitoring (CGM) will be performed for 10-14 days from baseline and at
weeks 5, 9, and 13.
Primary endpoint:
- Mean sensor glucose (mmol/L) evaluated by CGM
Key secondary endpoints:
- Incidence of hypoglycaemia
- Body weight (kg)
- Creatinine (μmol/L)
- Daily insulin dose (IE per day)
- Plasma concentration of semaglutide (nmol/L)
- Blood concentrations of cyclosporine and tacrolimus (μg/L)
Phase:
Phase 4
Details
Lead Sponsor:
Rigshospitalet, Denmark
Collaborators:
Aarhus University Hospital, Department of Nephrology Odense University Hospital, Department of Nephrology