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

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.

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Key information

Conditions

Kidney Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LCP Tacro (tacrolimus)

Drug

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.

Primary outcomes

Glucose metabolism disorders during tacrolimus treatment

Time frame: 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

Time frame: 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 outcomes

Fasting glucose

Time frame: over a period of 1-12 months

Changes in mean fasting glucose levels

Study contacts

Contact information is provided by the study sponsor or research team.

Roman Hożejowski, MD

CONTACT

[email protected]

+48 22 620 14 21

Tomasz Dębowski, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Chiesi Poland Sp. z o.o.

Industry

Registry information

Acronym: TARGET

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Feb 18, 2025
Registry last updated: Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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