Semaglutide Treatment for Hyperglycaemia After Renal Transplantation

Sponsor
Rigshospitalet, Denmark
Study ID
NCT05702931
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Diabetes
  • Hyperglycemia
  • Renal Transplant Complication Primary Non-Function

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide 14 MG [Rybelsus] — DRUG
    At baseline participants will initiate treatment with 3mg of oral semaglutide dosing from weeks 1 to 4. Depending on tolerability the dose will increase to 7 mg daily from weeks 5 to 8 and 14 mg from week 9. Trial medication will be dispensed to subjects for the first time immediately after randomisation and adjusted week 5 and week 9.
  • Placebo — DRUG
    Saline

Study Details

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 tablet semaglutide (Rybelsus) 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 tablet 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 or type 2 diabetes and an estimated glomerular filtration rate (eGFR) \> 15 ml/min/1.73 m2. Methods: Participants diagnosed with post-transplant hyperglycaemia or type 2 diabetes, 10 to 40 days post-transplant, will be randomised 1:1 to either 14 weeks of tablet semaglutide once daily 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)

Key Dates

Start date
Sep 19, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Semaglutide treated group
    Oral semaglutide once-daily as add-on to standard-of-care for post-transplant hyperglycaemia
  • Placebo Comparator: Placebo treated group
    Oral placebo once-daily as add-on to standard-of-care for post-transplant hyperglycaemia

Primary Outcome Measure

Mean sensor glucose (mmol/L) [ Time Frame: 14 weeks ]

Central Contacts

Related Studies