---
title: Monitoring Concentration and Pharmacodynamic Effects of Tacrolimus in Peripheral Blood Lymphocytes of Kidney Transplant Recipients
nct_id: NCT03425071
overall_status: UNKNOWN
sponsor: University of Sao Paulo General Hospital
study_type: OBSERVATIONAL
primary_condition: Kidney Transplantation
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03425071.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03425071"
ct_last_update_post_date: 2018-02-07
last_seen_at: "2026-05-12T06:34:54.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Monitoring Concentration and Pharmacodynamic Effects of Tacrolimus in Peripheral Blood Lymphocytes of Kidney Transplant Recipients

**Official Title:** Monitoring Intracellular Concentration and Pharmacodynamic Effects of Tacrolimus in Peripheral Blood T CD4+ and B CD19+ Lymphocytes of Kidney Transplant Recipients

**NCT ID:** [NCT03425071](https://clinicaltrials.gov/study/NCT03425071)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 45
- **Lead Sponsor:** University of Sao Paulo General Hospital
- **Collaborators:** Maria da Luz Fernandes, Paschoalina Romano, Persio de Almeida Rezende Ebner, Nairo Massakazu Sumita, Veronica Porto Carreiro de Vasconcelos Coelho, Fabiana Agena, Elias David Neto, Nelson Zocoler Galante
- **Conditions:** Kidney Transplantation, Rejection
- **Start Date:** 2016-03-08
- **Completion Date:** 2018-12
- **CT.gov Last Update:** 2018-02-07

## Brief Summary

Therapeutic drug monitoring (TDM) of immunosuppressive drugs is used to improve the immunosuppressive effect while minimizing the toxicity related to exposition to high serum levels. Although TDM is widely used in clinical practice, a significant number of kidney transplant recipients have acute allograft rejection in the first year after transplantation. To improve the use of immunosuppressive drugs, new approaches of TDM have been developed. Monitoring drug concentrations at lymphocytes of peripheral blood is considering promising because it indicates the availability of the drug directly in the target sites of immunosuppression. The present study intends to establish the concentration profile of tacrolimus in the peripheral blood in parallel with the concentration profile inside T and B lymphocytes of peripheral blood of kidney transplant recipients, and correlates them with the expected pharmacological effects. The pharmacological effects of tacrolimus in calcineurin dependent and calcineurin independent (mitogen-activated protein kinase (MAPK) dependent) activation pathways will be assessed by measuring activated nuclear factor of activated T cells (NFAT) and p38, respectively, by flow cytometry. The expression of interleukin (IL) - 2 and IL-10 by T and B lymphocytes, respectively, will be also used to monitoring the pharmacodynamic effects of tacrolimus.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Kidney transplant recipients with a well functioning graft (serum creatinine ≤ 2,0 mg/dL at inclusion)
* Must be on tacrolimus therapy
* Must be on short term follow up time (1 to 5 months) after surgery

Exclusion Criteria:

* A concomitant second solid organ transplant
* Immunosuppression not containing tacrolimus
```

## Arms

- **Healthy volunteers** — Healthy volunteers - subjects without exposure to tacrolimus. Blood samples from these subjects will be used in "in vitro" experiments.
- **kidney transplant (KTx) months 1-2** — Kidney transplant recipients recruited during the months 1 to 2 of follow up after kidney transplantation surgery. These are subjects expected to be exposed to high blood levels of tacrolimus. Blood samples from these subjects will be used in "ex vivo" experiments.
- **KTx months 4-5** — Kidney transplant recipients recruited during the months 4 to 5 of follow up after kidney transplantation surgery. These are subjects expected to be exposed to standard blood levels of tacrolimus. Blood samples from these subjects will be used in "ex vivo" experiments.

## Primary Outcomes

- **Correlation between blood and intracellular levels of tacrolimus** _(time frame: From 1 up to 5 months post transplantation)_ — The concentration of tacrolimus will be determined in the whole blood, in T CD4+ cell suspension and in B CD19+ cell suspension prepared from one blood sample per patient subject. The correlations among concentrations of tacrolimus in the 3 different cell matrices will be established.

## Secondary Outcomes

- **Correlation among intracellular levels of tacrolimus and its pharmacological effects** _(time frame: From 1 up to 5 months post transplantation)_

## Locations (1)

- Hospital das Clínicas - University of Sao Paulo, São Paulo, São Paulo, Brazil — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital das clínicas - university of sao paulo|são paulo|são paulo|brazil` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03425071.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03425071*  
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