NCT06833463 Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients
| NCT ID | NCT06833463 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chiesi Poland Sp. z o.o. |
| Condition | Kidney Transplant |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-05-29 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-05-29 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Alicja Dębska-Ślizień, Professor
PRINCIPAL INVESTIGATOR
Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk, Gdansk, Poland
Frequently Asked Questions
Who can join the NCT06833463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06833463 currently recruiting?
Yes, NCT06833463 is actively recruiting participants. Contact the research team at r.hozejowski@chiesi.com for enrollment information.
Where is the NCT06833463 trial being conducted?
This trial is being conducted at Gdansk, Poland, Krakow, Poland, Lodz, Poland, Poznan, Poland and 2 additional locations.
Who is sponsoring the NCT06833463 clinical trial?
NCT06833463 is sponsored by Chiesi Poland Sp. z o.o.. The principal investigator is Alicja Dębska-Ślizień, Professor at Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk, Gdansk, Poland. The trial plans to enroll 120 participants.
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