NFAT-regulated gene expression after tacrolimus

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001290-24-AT

Enrollment

Registered

2018-11-27

Start date

2018-12-11

Completion date

Unknown

Last updated

2021-12-21

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

Conditions

Immunosuppression after liver transplantation MedDRA version: 20.1 Level: PT Classification code 10062016 Term: Immunosuppression System Organ Class: 10021428 - Immune system disorders MedDRA version: 21.0 Level: LLT Classification code 10024716 Term: Liver transplantation System Organ Class: 100000004865

Interventions

Trade Name: Prograf 0,5 mg Hartkapseln Product Name: Prograf 0,5 mg Hartkapseln Pharmaceutical Form: Capsule, hard INN or Proposed INN: Tacrolimus Other descriptive name: TACROLIMUS MONOHYDRATE Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients >= 18 years of age -Liver transplantation -Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 27 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: -Patients < 18 years -Patients taking actively part in a different interventional Trial

Design outcomes

Primary

Measure	Time frame
Main Objective: - To test the hypothesis that there is an inverse correlation of NFAT-regulated gene-Expression (RGE) and Tacrolimus (TAC) peak levels at 1.5 hours after TAC intake in de-novo Tacrolimus (TAC) patients after liver transplantation.;Secondary Objective: - To evaluate the correlation between both NFAT-RGE and TAC levels with rejection episodes and TAC side effects ;Primary end point(s): NFAT-RGE and TAC peak levels at 1.5 hours after intake of TAC ;Timepoint(s) of evaluation of this end point: 1 day, 1 week, 2 weeks, 1 month, and for 6 and 12 months nach Transplantation	—

Measure

Time frame

Main Objective: - To test the hypothesis that there is an inverse correlation of NFAT-regulated gene-Expression (RGE) and Tacrolimus (TAC) peak levels at 1.5 hours after TAC intake in de-novo Tacrolimus (TAC) patients after liver transplantation.;Secondary Objective: - To evaluate the correlation between both NFAT-RGE and TAC levels with rejection episodes and TAC side effects ;Primary end point(s): NFAT-RGE and TAC peak levels at 1.5 hours after intake of TAC ;Timepoint(s) of evaluation of this end point: 1 day, 1 week, 2 weeks, 1 month, and for 6 and 12 months nach Transplantation

—

Secondary

Measure	Time frame
Secondary end point(s): Occurrence of rejection episodes and occurrence of TAC side effects;Timepoint(s) of evaluation of this end point: 1 day, 1 week, 2 weeks, 1 month, and for 6 and 12 months nach Transplantation	—

Countries

Austria

Contacts

Public ContactClinical Trials Information

Medical University of Graz

judith.kahn@medunigraz.at00430316385 26101

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026