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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Poland
Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk
RECRUITING
Gdansk
Clinical Department of Nephrology, Dialysis, Transplantology and Internal Medicine
NOT_YET_RECRUITING
Krakow
Department of Internal Diseases and Transplant Nephrology, Medical University of Lodz
NOT_YET_RECRUITING
Lodz
Department of Transplantology and General Surgery, Provincial Hospital
NOT_YET_RECRUITING
Poznan
Department and Clinic of Nephrology, Dialysis and Internal Medicine, Medical University of Warsaw
NOT_YET_RECRUITING
Warsaw
Department and Clinic of Nephrology and Transplantation Medicine, University Clinical Hospital
NOT_YET_RECRUITING
Wroclaw
Contact Information
Primary
Roman Hożejowski, MD
r.hozejowski@chiesi.com
+48 22 620 14 21
Backup
Tomasz Dębowski, MD, PhD
t.debowski@chiesi.com
Time Frame
Start Date: 2025-05-29
Estimated Completion Date: 2028-01-30
Participants
Target number of participants: 120
Related Therapeutic Areas
Sponsors
Leads: Chiesi Poland Sp. z o.o.

This content was sourced from clinicaltrials.gov