Measuring Tacrolimus Metabolites in Blood and Bile to Predict Side Effects in Liver Transplant Patients
Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients
This study is trying to see if measuring certain levels of a medication in the blood can help predict side effects in people who have just received a liver transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 1 site (Rennes) |
| Trial ID | NCT05277792 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess whether the concentration of tacrolimus metabolites in the blood is elevated in liver transplant recipients experiencing side effects from tacrolimus. Blood samples will be collected daily from Day 1 to Day 5 post-transplant to measure the levels of tacrolimus and its metabolites. The goal is to determine if higher metabolite levels correlate with tacrolimus toxicity, potentially guiding future treatment decisions.
Who should consider this trial
Good fit: Ideal candidates include adult patients over 18 years who are undergoing liver transplantation or retransplantation.
Not a fit: Patients who are receiving another organ transplant simultaneously or have contraindications to tacrolimus will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help predict and manage side effects of tacrolimus in liver transplant patients, improving their overall treatment outcomes.
How similar studies have performed: While the approach of measuring drug metabolites is common, this specific study's focus on tacrolimus metabolites in liver transplant patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (\> 18 years) of both sexes, * Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease, * Not having expressed their opposition to participation in the study Exclusion Criteria: * Associated transplantation of another organ * Contraindications to TAC administration * Delayed introduction of TAC (beyond the 5th postoperative day) whatever the cause.
Where this trial is running
Rennes
- CHU Rennes — Rennes, France (Recruiting)
Study contacts
- Study coordinator: Michel RAYAR, MD-PhD
- Email: michel.rayar@chu-rennes.fr
- Phone: 299288498
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.