Tacrolimus in CD3+ T Lymphocytes

NCT06342505 | Completed DMC

• 1 other identifier: MEC-2022-0037
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to measure concentrations of the drug tacrolimus in both whole blood and within T lymphocytes. It will also learn on the correlation between the concentration in T lymphocytes and the effects of the drug. The main questions are: (i) What is the ratio between the tacrolimus concentration within T lymphocytes and in whole blood?; (ii) What is the correlation between tacrolimus concentrations and the effects of the drug? Participants will:

• Receive standard clinical care;
• Undergo two extra venipunctures for the collection of blood.

Conditions

Immunosuppression

Keywords

Pharmacokinetics; Tacrolimus; Kidney transplantation; Intracellular T lymphocyte concentration

Outcome Measures

Primary Outcomes (1)

• The intracellular tacrolimus concentration in CD3+ T lymphocytes

  The tacrolimus concentration in T lymphocytes will be measured by a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The concentration measured is reported in μg/L. The intracellular tacrolimus concentration will then be calculated and reported in pg/million cells (range 5-1,250 pg/million cells).

  Follow-up to one month post-transplantation

Secondary Outcomes (1)

• Intracellular cytokine production

  Follow-up to one month post-transplantation

Study Arms (1)

De novo kidney transplant recipients

Intervention: Two extra venipunctures for the collection of blood. Drug: Once-daily extended-release tacrolimus formulation with a standard, body-weight-based starting dose of 0.14 mg/kg/day

Procedure: Venipunctures

Interventions

Venipunctures PROCEDURE

Extra venipunctures

De novo kidney transplant recipients

Eligibility Criteria

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

Study Population

Recipients of a kidney transplant at the Erasmus MC who receive routine tacrolimus-based immunosuppression as part of routine clinical care.

You may qualify if:

• Age ≥ 18 years.
• Receive a kidney transplant at Erasmus MC.
• Use once-daily tacrolimus as part of routine maintenance immunosuppression starting the day of surgery.
• Written informed consent.

You may not qualify if:

• Receive lymphocyte depleting agents (thymoglobulin, anti-thymocyte globulin, and alemtuzumab) as an induction therapy or anti-rejection treatment before the enrolment (lymphocyte depleting agents will lower the amount of CD3+ T lymphocytes to the level that they cannot be isolated for the measurement of intracellular tacrolimus concentration).

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

MeSH Terms

Interventions

Phlebotomy

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Brenda C.M. de Winter, PharmD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD, PhD

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: May 30, 2022
• Primary Completion: October 10, 2022
• Study Completion: November 10, 2022
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)