Tacrolimus effects on blood sugar after kidney transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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 Transplantology and General Surgery, Provincial Hospital
  Poznan, Poland Recruiting
• Department and Clinic of Nephrology and Transplantation Medicine, University Clinical Hospital
  Wroclaw, Poland Recruiting
• Department of Internal Diseases and Transplant Nephrology, Medical University of Lodz
  Lodz, Poland Not yet recruiting
• Department and Clinic of Nephrology, Dialysis and Internal Medicine, Medical University of Warsaw
  Warsaw, Poland Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.