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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplant
• Intervention / Treatment: Drug: LCP Tacro (tacrolimus)

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Roman Hożejowski, MD; Phone Number: +48 22 620 14 21; Email: r.hozejowski@chiesi.com
• Study Contact Backup: Name: Tomasz Dębowski, MD, PhD; Email: t.debowski@chiesi.com

Study Locations

• Poland
  • Gdansk, Poland, 80-952
    • Recruiting
    • Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk
    • Contact: Alicja Dębska-Ślizień, Professor; Phone Number: +48 58 584 4700; Email: adeb@gumed.edu.pl
  • Krakow, Poland, 30-688
    • Recruiting
    • Clinical Department of Nephrology, Dialysis, Transplantology and Internal Medicine
    • Contact: Katarzyna Krzanowska, Professor; Phone Number: +48 12 400 28 50; Email: kasiakrzanowska@op.pl
  • Lodz, Poland, 90-153
    • Not yet recruiting
    • Department of Internal Diseases and Transplant Nephrology, Medical University of Lodz
    • Contact: Ilona Kurnatowska, Professor; Phone Number: +48 42 291 95 97; Email: kuril@wp.pl
  • Poznan, Poland, 60-479
    • Recruiting
    • Department of Transplantology and General Surgery, Provincial Hospital
    • Contact: Maciej Głyda, Professor; Phone Number: +48 61 821 22 27; Email: glydam@wp.pl
  • Warsaw, Poland, 02-097
    • Not yet recruiting
    • Department and Clinic of Nephrology, Dialysis and Internal Medicine, Medical University of Warsaw
    • Contact: Jolanta Małyszko, Professor; Phone Number: +48 22 599 26 58; Email: jmalyszko@wum.edu.pl
  • Wroclaw, Poland, 50-556
    • Recruiting
    • Department and Clinic of Nephrology and Transplantation Medicine, University Clinical Hospital
    • Contact: Mirosław Banasik, Professor; Phone Number: +48 71 733 25 00; Email: m.banasik@interia.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult kidney graft receipients transplanted in the participating study sites

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,	The endpoint will be determined at 3, 6, and 12 months after transplantation
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	3, 6, and 12 months after transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose	Changes in mean fasting glucose levels	over a period of 1-12 months

Collaborators and Investigators

• Sponsor: Chiesi Poland Sp. z o.o.
• Investigators: Principal Investigator: Alicja Dębska-Ślizień, Professor, Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk, Gdansk, Poland

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Organic Chemicals; Macrolides; Lactones; Tacrolimus
• Other Study ID Numbers: CHI-PL-ENV-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No