Impact of P-gp, MRP2, ENT-1 and CNT3 on the Blood Concentration / Intra-PBMC Concentration of Tacrolimus

NCT03910868 | Completed

• 1 other identifier: 35RC19_30018_TRANS-TAC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective and monocentric pharmacokinetic study

Conditions

Liver Transplantation; Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Correlation between drug transporters expression (RNA and protein) in PBMC and tacrolimus intra-PBMC concentration

  The mRNA levels will be recorded as a cycle threshold difference between the studied gene, and the mean of two housekeeping genes (ACTB and B2M). The proteic expression of the studied transporters will be recorded as fluorescent intensity levels

  During the consultation (between 2 and 24 months after the transplant)

Secondary Outcomes (5)

• Correlation between drug transporters RNA expression in PBMC and drug transporters protein expression in PBMC

  During the consultation (between 2 and 24 months after the transplant)

• Correlation between tacrolimus blood to intracellular ratio and adverse events.

  During the consultation (between 2 and 24 months after the transplant)

• Correlation between tacrolimus intra-PBMC concentration and treatment outcome

  During the consultation (between 2 and 24 months after the transplant)

• Correlation between tacrolimus intra-PBMC concentration and comedications

  During the consultation (between 2 and 24 months after the transplant)

• Correlation between tacrolimus intra-PBMC concentrations and Donor Graft cell-free DNA (cf-DNA) concentration

  During the consultation (between 2 and 24 months after the transplant)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hepatic and / or renal transplantation

You may qualify if:

• Adult of 18 or over;
• fully and honestly informed, and not having reported his non-opposition to the use of his samples for research;
• Affiliated to a social security scheme;
• Hepatic and / or renal transplant stable between two and twenty-four months after transplantation, treated with tacrolimus;
• Without modification of immunosuppressive treatment or treatment likely to modify their pharmacokinetics (imidazoles, macrolides ...) during the last two weeks;
• Each patient can only be included once.

You may not qualify if:

• Participation in another protocol whose procedures are incompatible with the realization of the study;
• Pregnant woman ;
• Major person subject to legal protection (safeguard of justice, guardianship, tutorship);
• Person deprived of liberty;
• Opposition to the use of clinical data and remnants of samples taken from care for research purposes.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

Study Officials

• Florian LEMAITRE

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 10, 2019
• Study Start: July 16, 2020
• Primary Completion: December 16, 2020
• Study Completion: December 16, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

FR (1)