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

Condition(s) studied

Investigational drug(s) / intervention(s)

LCP Tacro (tacrolimus): 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (6)

More Chiesi Poland Sp. z o.o. trials in Poland

Other trials for the same condition