Kidney Transplant
Conditions
Brief summary
Many people who receive a kidney transplant develop problems with how their body processes sugar (glucose). This includes conditions like prediabetes and diabetes, which can lead to more health issues, such as heart problems and infections. One of the main medications used after a kidney transplant, called tacrolimus, can contribute to these sugar problems. Tacrolimus helps protect the new kidney, but it can also harm the cells in the pancreas that produce insulin, a hormone that controls blood sugar. Other factors, such as stress on the body and insulin resistance, can make things worse. The effect of tacrolimus on blood sugar may depend on how the body processes the drug. Some people break down tacrolimus quickly (fast metabolizers), so they need higher doses to reach the right level in their blood. Others break it down more slowly (slow metabolizers) and require lower doses. Doctors can measure how fast someone metabolizes tacrolimus using aparameter called the concentration-to-dose (C/D) ratio. This study aims to find out what increases the risk of developing blood sugar problems after a kidney transplant. It will focus on how quickly patients process tacrolimus and whether this affects their risk of developing diabetes. The study will also look at how common these issues are in kidney transplant patients in Poland.
Interventions
Treatment with LCP Tacro will begin on the day of the kidney transplant. If a patient is switching from another form of tacrolimus to LCP Tacro, the transition will be completed no later than day 8, following the standard procedures of the medical institution.
Sponsors
Chiesi Poland Sp. z o.o.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose metabolism disorders during tacrolimus treatment | The endpoint will be determined at 3, 6, and 12 months after transplantation | Percentage of patients diagnosed with: * Impaired fasting glucose and/or glucose intolerance (prediabetes) * Post-transplant diabetes mellitus (PTDM) requiring pharmacotherapy, |
| Risk factors for glucose metabolism disorders | 3, 6, and 12 months after transplantation | Odds ratio for glucose metabolism disorders (prediabetes, PTDM) for the following variables: the rate of tacrolimus metabolism, cumulative tacrolimus exposure, cumulative glicocorticosteroid exposure, age, sex, body mass index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glucose | over a period of 1-12 months | Changes in mean fasting glucose levels |
Countries
Poland
Contacts
CONTACTRoman Hożejowski, MD
CONTACTTomasz Dębowski, MD, PhD
PRINCIPAL_INVESTIGATORAlicja Dębska-Ślizień, Professor
Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk, Gdansk, Poland
Outcome results
None listed