Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients
ConditionKidney Transplant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChiesi Poland Sp. z o.o.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult kidney graft receipients transplanted in the participating study sites
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
LCP Tacro (tacrolimus)
DrugTreatment 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Glucose metabolism disorders during tacrolimus treatment
Percentage of patients diagnosed with: * Impaired fasting glucose and/or glucose intolerance (prediabetes) * Post-transplant diabetes mellitus (PTDM) requiring pharmacotherapy,
Time frame
The endpoint will be determined at 3, 6, and 12 months after transplantation2
Risk factors for glucose metabolism disorders
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
Time frame
3, 6, and 12 months after transplantationSecondary outcomes
1
Fasting glucose
Changes in mean fasting glucose levels
Time frame
over a period of 1-12 monthsSponsors and contacts
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Source ClinicalTrials.gov