Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients

Launched by CHIESI POLAND SP. Z O.O. · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the medication tacrolimus affects blood sugar levels in people who have received a kidney transplant. After a transplant, some patients develop problems with how their body processes sugar, which can lead to conditions like prediabetes and diabetes. The trial aims to understand what factors might increase the risk of these blood sugar issues, particularly focusing on how quickly different patients process tacrolimus. This is important because the speed at which a person breaks down this medication can influence their risk of developing diabetes.

To participate in the study, individuals must be at least 18 years old and have received a kidney transplant, either from a living or deceased donor. They should be on a standard post-transplant medication regimen that includes tacrolimus. However, people who already have diabetes or other specific health conditions will not be eligible. Participants can expect to have their blood sugar levels monitored, and the study will help provide valuable information about managing blood sugar in kidney transplant patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Recipients of a kidney transplant from a living or deceased donor
• • Standard immunosuppressive regimen post-kidney transplantation (KTx) including Envarsus®
• • LCP Tacrolimus therapy initiated from the day of KTx or conversion from another tacrolimus formulation to LCP Tacrolimus by day 8 at the latest, according to the institution's routine practice
• • Informed patient consent to participate in the study
• Exclusion Criteria:
• • Diagnosis of diabetes (type 1 or type 2) treated with diet or glucose-lowering drugs
• • Random glycemia/HbA1c levels justifying a diagnosis of diabetes at the time of study enrollment
• • Kidney retransplantation
• • Recipients of a multi-organ transplant
• • Use of glucagon-like peptide-1 (GLP-1) receptor agonists for weight loss
• • Use of flozins for renal or cardiac indications
• • Chronic use of drugs affecting carbohydrate metabolism, such as glucocorticosteroids