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

NCT06833463 | Recruiting

• 1 other identifier: CHI-PL-ENV-03
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Fasting glucose

  over a period of 1-12 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult kidney graft receipients transplanted in the participating study sites

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiesi Poland Sp. z o.o.: lead

Study Sites (6)

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

Gdansk, 80-952, Poland

RECRUITING

Clinical Department of Nephrology, Dialysis, Transplantology and Internal Medicine

Krakow, 30-688, Poland

RECRUITING

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

Lodz, 90-153, Poland

NOT YET RECRUITING

Department of Transplantology and General Surgery, Provincial Hospital

Poznan, 60-479, Poland

RECRUITING

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

Warsaw, 02-097, Poland

NOT YET RECRUITING

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

Wroclaw, 50-556, Poland

RECRUITING

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Alicja Dębska-Ślizień, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roman Hożejowski, MD

CONTACT

+48 22 620 14 21; r.hozejowski@chiesi.com

Tomasz Dębowski, MD, PhD

CONTACT

t.debowski@chiesi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

PL (6)