Actively Recruiting
Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients
Led by Chiesi Poland Sp. z o.o. · Updated on 2026-04-02
120
Participants Needed
6
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �318 years
- Recipients of a kidney transplant from a living or deceased donor
- Receiving a standard immunosuppressive regimen after kidney transplantation including Envarsus�ae
- Started LCP Tacrolimus treatment from the day of transplant or converted to it from another tacrolimus form by day 8
- Provided informed consent to participate in the study
You will not qualify if you...
- Diagnosed with type 1 or type 2 diabetes treated with diet or glucose-lowering drugs
- Blood sugar levels at enrollment indicating diabetes
- Underwent kidney retransplantation
- Received a transplant involving multiple organs
- Using glucagon-like peptide-1 receptor agonists for weight loss
- Using flozins for kidney or heart conditions
- Chronically using drugs that affect carbohydrate metabolism such as glucocorticosteroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk
Gdansk, Poland, 80-952
Actively Recruiting
2
Clinical Department of Nephrology, Dialysis, Transplantology and Internal Medicine
Krakow, Poland, 30-688
Actively Recruiting
3
Department of Internal Diseases and Transplant Nephrology, Medical University of Lodz
Lodz, Poland, 90-153
Not Yet Recruiting
4
Department of Transplantology and General Surgery, Provincial Hospital
Poznan, Poland, 60-479
Actively Recruiting
5
Department and Clinic of Nephrology, Dialysis and Internal Medicine, Medical University of Warsaw
Warsaw, Poland, 02-097
Not Yet Recruiting
6
Department and Clinic of Nephrology and Transplantation Medicine, University Clinical Hospital
Wroclaw, Poland, 50-556
Actively Recruiting
Research Team
R
Roman Hożejowski, MD
CONTACT
T
Tomasz Dębowski, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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