Tacrolimus effects on blood sugar after kidney transplant
Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients
This study tests whether how quickly adults break down tacrolimus affects their risk of developing prediabetes or diabetes after a kidney transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chiesi Poland Sp. z o.o. Industry-sponsored |
| Locations | 6 sites (Gdansk and 5 other locations) |
| Trial ID | NCT06833463 on ClinicalTrials.gov |
What this trial studies
This is an observational study of adult kidney transplant recipients treated with LCP tacrolimus (Envarsus®) as part of standard immunosuppression. Researchers will measure tacrolimus blood concentrations and dosing to calculate a concentration-to-dose ratio and classify patients as faster or slower metabolizers. They will then track new problems with glucose metabolism (such as prediabetes or diabetes) in patients who did not have diabetes at enrollment. Patients must start LCP tacrolimus on the day of transplant or convert to it by day 8 according to routine care at participating Polish transplant centers.
Who should consider this trial
Good fit: Adults (age ≥18) who received a single-organ kidney transplant, are placed on standard immunosuppression including LCP tacrolimus started at transplant or converted by day 8, and do not have diabetes at enrollment are ideal candidates.
Not a fit: People with pre-existing diabetes, kidney retransplantation or multi-organ transplants, or those on chronic drugs that affect carbohydrate metabolism are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the findings could help clinicians personalize tacrolimus dosing to lower the chance of new-onset glucose problems after kidney transplant.
How similar studies have performed: Previous research has linked tacrolimus to new-onset diabetes and suggested metabolism rate affects toxicity, but applying LCP tacrolimus concentration-to-dose profiling specifically to predict post-transplant glucose disorders is relatively underexplored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gdansk and 5 other locations
- Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk — Gdansk, Poland (Recruiting)
- Clinical Department of Nephrology, Dialysis, Transplantology and Internal Medicine — Krakow, Poland (Recruiting)
- Department of Internal Diseases and Transplant Nephrology, Medical University of Lodz — Lodz, Poland (Not_yet_recruiting)
- Department of Transplantology and General Surgery, Provincial Hospital — Poznan, Poland (Recruiting)
- Department and Clinic of Nephrology, Dialysis and Internal Medicine, Medical University of Warsaw — Warsaw, Poland (Not_yet_recruiting)
- Department and Clinic of Nephrology and Transplantation Medicine, University Clinical Hospital — Wroclaw, Poland (Recruiting)
Study contacts
- Principal investigator: Alicja Dębska-Ślizień, Professor — Department of Nephrology, Transplantology and Internal Diseases, Medical University of Gdansk, Gdansk, Poland
- Study coordinator: Roman Hożejowski, MD
- Email: r.hozejowski@chiesi.com
- Phone: +48 22 620 14 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.