Immunosuppressive Therapy Optimization: Development of a Population Pharmacokinetic-pharmacodynamic (PK-PD) Model in Liver Transplantation

NCT02877628 | Completed

• 1 other identifier: 35RC13_8962_OPTILTH
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic monocentric study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be communicate to clinicians or patients during the study.

Conditions

Liver Transplantation

Keywords

pharmacokinetic; pharmacodynamic; tacrolimus; CYP3A5; liver transplantation

Outcome Measures

Primary Outcomes (4)

• Prediction of calcineurin inhibition, responsible for the immunosuppressive effect

  Assessement of the relationships between tacrolimus dosage, whole-blood and intracellular concentrations

  Week 24

• Prediction of calcineurin inhibition, responsible for the immunosuppressive effect

  Assessement of the relationships between intracellular concentrations of tacrolimus and calcineurin activity

  Week 24

• Prediction of calcineurin inhibition, responsible for the immunosuppressive effect

  Assessement of the relationships between donor and recipient CYP3A5 and ABCB1 genotypes and dose/concentration of tacrolimus

  Week 24

• Prediction of calcineurin inhibition, responsible for the immunosuppressive effect

  Assessement of the relationships between intracellular concentration of tacrolimus and/or calcineurin activity and ACR, in patients treated with immediate release or modified-release formulation of tacrolimus

  Week 24

Secondary Outcomes (3)

• Study of impact of pharmacogenetic and demographic data on tacrolimus intracellular concentration

  Week 24

• Evaluation of the role of the measurement of intracellular concentration as a longitudinal biomarker in preventing acute cellular graft (ACR)

  Week 24

• Study of variability of tacrolimus intracellular concentration according to its pharmaceutic form (immediate or sustained release)

  Week 24

Interventions

Pharmacokinetic-pharmacodynamic model in liver transplantation OTHER

Biological: tacrolimus and calcineurin dosage, donor and recipient CYP3A5 and ABCB1 genotypes determination

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

Patient with liver tranplantation

You may qualify if:

• Adults over 18
• Liver transplant recipients
• Treated with an immunosuppressive protocol with tacrolimus
• Informed on the study and who did not refuse to participate

You may not qualify if:

• Patients who participate in a study with procedures incompatible with the present study.
• Patients with legal protection/deprived of liberty.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Interventions

Liver Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Design

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

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 24, 2016
• Study Start: October 31, 2015
• Primary Completion: November 29, 2018
• Study Completion: December 1, 2018
• Last Updated: January 28, 2019

Record last verified: 2019-01

Locations

FR (1)