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

NCT06833463 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-04-02

No results posted yet for this 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.

Conditions

  • Kidney Transplant

Interventions

DRUG

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.

Sponsors & Collaborators

  • Chiesi Poland Sp. z o.o.

    lead INDUSTRY

Principal Investigators

  • Alicja Dębska-Ślizień, Professor · Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk, Gdansk, Poland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-29
Primary Completion
2027-10-30
Completion
2028-01-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06833463 on ClinicalTrials.gov