Clinical trial NCT06833463: Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients
Official title: Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Kidney Transplant
Lead sponsor: Chiesi Poland Sp. z o.o.
Sponsor class: INDUSTRY
First posted: 2025-02-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult kidney graft receipients transplanted in the participating study sites

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.


Eligibility criteria: 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

Primary outcomes:
measure: Glucose metabolism disorders during tacrolimus treatment
timeFrame: The endpoint will be determined at 3, 6, and 12 months after transplantation
measure: Risk factors for glucose metabolism disorders
timeFrame: 3, 6, and 12 months after transplantation
Secondary outcomes:
measure: Fasting glucose
timeFrame: over a period of 1-12 months
Other outcomes:
Locations:
city: Cracow
country: Poland
facility: Clinical Department of Nephrology, Dialysis, Transplantology and Internal Medicine
city: Gdansk
country: Poland
facility: Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk
city: Lodz
country: Poland
facility: Department of Internal Diseases and Transplant Nephrology, Medical University of Lodz
city: Poznan
country: Poland
facility: Department of Transplantology and General Surgery, Provincial Hospital
city: Warsaw
country: Poland
facility: Department and Clinic of Nephrology, Dialysis and Internal Medicine, Medical University of Warsaw
city: Wroclaw
country: Poland
facility: Department and Clinic of Nephrology and Transplantation Medicine, University Clinical Hospital
Study officials:
affiliation: Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk, Gdansk, Poland
name: Alicja Dębska-Ślizień, Professor
role: PRINCIPAL_INVESTIGATOR
References: