Evaluation of the Impact of Tacrolimus-based Immunosuppression on Heidelberg Liver Transplant Cohort (HDTACRO): Study Protocol for an Investigator Initiated, Non-interventional Prospective Study

NCT04444817 | Unknown

• 1 other identifier: S-260/2018
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Modern immunosuppression is characterized by a combination of different immunosuppressants. As a result, the dose of the individual substances, and thus also their side effects can be reduced. Immunosuppression on the basis of low-dose calcineurin inhibitors (CNI) with comparatively low CNI target levels could therefore prevail. Despite all efforts to optimize the treatment regimen after liver transplantation from deceased donors, the amount of medication remains high throughout the postoperative course with CNIs being the main component of immunosuppressive treatment. The main substance used is Tacrolimus in combination with steroids and possibly Mycophenolic acid. Tacrolimus is considered a narrow therapeutic index drug requiring individual dose titration, to achieve a satisfactory balance between maximizing efficacy and minimizing dose-related toxicity. Furthermore, transplanted recipients have to remain to a very demanding medication regimen for a long time. The burden of pills required is associated with decreased adherence, and lack of adherence can lead to rejection and possibly graft loss. The aim of present study is to assess the tough levels and need of doses adaptation in de novo liver transplantation with Tacrolimus in the clinical routine, without any intervention in the treatment regimen.

Conditions

Liver Transplantation

Keywords

Tacrolimus; immunosuppression; Liver transplantation

Outcome Measures

Primary Outcomes (1)

• The number of required dose adjustments of Tacrolimus formulations used in clinical routine for achieving the target tough level

  Six months

Secondary Outcomes (10)

• Tacrolimus tough level

  Six months

• Tacrolimus dosing

  Six months

• Concentration/dose ratio

  Six months

• Mean cumulative dose for cost analysis

  Six months

• Routine laboratory tests

  Six months

Study Arms (1)

Tacrolimus-based immunosuppression

Similar to the clinical routine, as soon as a patient is able to swallow and has a sufficient gastrointestinal activity, Tacrolimus-based immunosuppression using Prograf®, Advagraf® or Envarsus® will be started.

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

Similar to the clinical routine, as soon as a patient is able to swallow and has a sufficient gastrointestinal activity, Tacrolimus-based immunosuppression using Prograf®, Advagraf® or Envarsus® will be started. Furthermore, calcineurin inhibitors-based immunosuppression will be used (initial dose based on the patients' body weight) with the goal of tough levels of 3-7 ng/mL in the first seven days after liver transplantion, depending on immune status and indication for transplantation. Further tough levels will be determined based on factors such as patients' history and indication for liver transplant.

Tacrolimus-based immunosuppression

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

One hundred Recipients who underwent de novo liver transplant and treated with various oral Tacrolimus-based immunosupresions (Prograf®, Advagraf® and Envarsus®)

You may qualify if:

• \< Recipient Age ≤ 60 years old
• Ability to understand and sign an informed consent form
• Operation and immediate post-operative therapy within the Department of General, Visceral and Transplantion Surgery, University Hospital Heidelberg
• De novo liver transplantation until POD 7
• Immunosuppression after liver transplantation based on Tacrolimus

You may not qualify if:

• Re-transplantation
• Acute infection of the biliary tract, pneumonia or CMV infection

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

Division of Visceral Transplantation, Department of General, Visceral andTransplantation Surgery, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related Publications (1)

• Khajeh E, Polychronidis G, Ramouz A, Alamdari P, Lemekhova A, Saracevic M, Ali-Hasan-Al-Saegh S, Ghamarnejad O, Majlesara A, Abbasi Dezfouli S, Nickkholgh A, Weiss KH, Rupp C, Mehrabi A, Mieth M. Evaluation of the impact of Tacrolimus-based immunosuppression on Heidelberg liver transplant cohort (HDTACRO): Study protocol for an investigator initiated, non-interventional prospective study. Medicine (Baltimore). 2020 Sep 25;99(39):e22180. doi: 10.1097/MD.0000000000022180.

  PMID: 32991411 DERIVED

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Central Study Contacts

Arianeb Mehrabi, MD

CONTACT

004962215636223; arianeb.mehrabi@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professsor, Head of the Division of Liver Surgery and Visceral Transplantation

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: June 24, 2020
• Study Start: November 22, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: June 24, 2020

Record last verified: 2020-06

Locations

DE (1)