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Improved determination of tacrolimus in immune cells (OPTIMAL-TAC)

Optimized intra- T cell tacrolimus assay with Easysep® (OPTIMAL-TAC) - Optimization of the intra-T lymphocyte tacrolimus concentration assay with Easysep®.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON61188
Enrollment
12
Registered
2026-03-30
Start date
2026-06-08
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplantation, Renal transplantation, Post-kidney transplant state, Solid organ transplantation (kidney), Organ transplantation (renal), Post-transplant immunosuppression, Tacrolimus Kidney transplantation, new kidney, organ transplantation, immune system, tacrolimus

Interventions

This study investigates whether the previously developed Ficoll-paque density centrifugation and Automacs isolation procedures can be replaced by the much more time-efficient Easysep isolation, which

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Tacrolimus-Prograf® (twice-daily tacrolimus formulation)-based immunosuppressive regimen  Written informed consent  Patient is not receiving T-cel depleting antibody therapy with Rabbit anti-thymocyte globulin (rATG) or alemtuzumab or has a T-cel count of at least >200 x 10^6/L. 

Exclusion criteria

Exclusion criteria: Age <18y Recipients of a non-renal organ transplant at the same occasion.  

Design outcomes

Primary

MeasureTime frame
The proportion of intra-T lymphocyte tacrolimus measurements obtained with the EasySep ® isolation method that deviate by >15% from the measurements obtained with the reference method (Ficoll-Paque density centrifugation and Automacs). 

Secondary

MeasureTime frame
 1) To optimize the timing of the addition of the P-gp blocking drug verapamil and 2) to evaluate the influence of patient characteristics on the whole blood to intraT lymphocyte concentration ratio at two timepoints after dose administration. 

Countries

Netherlands

Contacts

Public ContactL. Mingels

Erasmus MC, Universitair Medisch Centrum Rotterdam

l.mingels@erasmusmc.nl0648485242

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026