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

Last updated: April 1, 2026
Sponsor: Chiesi Poland Sp. z o.o.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metabolic Disorders

Treatment

LCP Tacro (tacrolimus)

Clinical Study ID

NCT06833463
CHI-PL-ENV-03
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Recipients of a kidney transplant from a living or deceased donor

  • Standard immunosuppressive regimen post-kidney transplantation (KTx) includingEnvarsus®

  • LCP Tacrolimus therapy initiated from the day of KTx or conversion from anothertacrolimus formulation to LCP Tacrolimus by day 8 at the latest, according to theinstitution's routine practice

  • Informed patient consent to participate in the study

Exclusion

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 studyenrollment

  • 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

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: LCP Tacro (tacrolimus)
Phase:
Study Start date:
May 29, 2025
Estimated Completion Date:
January 30, 2028

Connect with a study center

  • Clinical Department of Nephrology, Dialysis, Transplantology and Internal Medicine

    Cracow, 30-688
    Poland

    Site Not Available

  • Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk

    Gdansk, 80-952
    Poland

    Active - Recruiting

  • Clinical Department of Nephrology, Dialysis, Transplantology and Internal Medicine

    Krakow, 30-688
    Poland

    Active - Recruiting

  • Clinical Department of Nephrology, Dialysis, Transplantology and Internal Medicine

    Kraków, 30-688
    Poland

    Site Not Available

  • Department of Internal Diseases and Transplant Nephrology, Medical University of Lodz

    Lodz, 90-153
    Poland

    Site Not Available

  • Department of Transplantology and General Surgery, Provincial Hospital

    Poznan, 60-479
    Poland

    Active - Recruiting

  • Department and Clinic of Nephrology, Dialysis and Internal Medicine, Medical University of Warsaw

    Warsaw, 02-097
    Poland

    Site Not Available

  • Department and Clinic of Nephrology and Transplantation Medicine, University Clinical Hospital

    Wroclaw, 50-556
    Poland

    Active - Recruiting

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