null - FindTrial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004944-23-DE

Enrollment

210

Registered

2011-12-05

Start date

2012-03-01

Completion date

Unknown

Last updated

2014-06-02

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

Conditions

graft function adapted tacrolimus therapy after liver transplantation MedDRA version: 14.1 Level: LLT Classification code 10024716 Term: Liver transplantation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Prograf Pharmaceutical Form: Capsule, hard CAS Number: 109581-93-3 Other descriptive name: TACROLIMUS MONOHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients intended for orthotopic deceased-donor LT - Recipient age =18 yrs. - Capability to understand the purpose and the risk of the study - Written informed consent prior LT 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 210 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: number of patients suffering from either toxic or insufficient tacrolimus whole blood troungh level durind the initial 14 days after liver transplantation;Secondary Objective: • Tacrolimus whole blood trough level during post-transplant days 1-14 and week 12 • Total cumulative incidence of inadequate tacrolimus whole blood trough levels during post-transplant days 1-14 (20 ng/mL) • Creatinine serum levels (time frame: post-transplant days 1-14, week 12) • Adverse effects of Prograf®/ Advagraf® (time frame: 12 weeks) o Increase of serum creatinine >50% o Renal failure requiring pharmacological intervention and/ or hemodialysis o Neurological effects including encephalopathy, seizures or coma • Incidence of acute graft rejection (time frame: 12 weeks) • Rejection free time interval (acute cellular rejection) after LT (time frame: 12 weeks) • Assessment of graft survival (time frame: 12 weeks) ;Primary end point(s):	—

Measure

Time frame

Main Objective: number of patients suffering from either toxic or insufficient tacrolimus whole blood troungh level durind the initial 14 days after liver transplantation;Secondary Objective: • Tacrolimus whole blood trough level during post-transplant days 1-14 and week 12 • Total cumulative incidence of inadequate tacrolimus whole blood trough levels during post-transplant days 1-14 (20 ng/mL) • Creatinine serum levels (time frame: post-transplant days 1-14, week 12) • Adverse effects of Prograf®/ Advagraf® (time frame: 12 weeks) o Increase of serum creatinine >50% o Renal failure requiring pharmacological intervention and/ or hemodialysis o Neurological effects including encephalopathy, seizures or coma • Incidence of acute graft rejection (time frame: 12 weeks) • Rejection free time interval (acute cellular rejection) after LT (time frame: 12 weeks) • Assessment of graft survival (time frame: 12 weeks) ;Primary end point(s):

—

Countries

Germany

Contacts

Public ContactMartin Stockmann

Charité – Universitätsmedizin Berlin, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

martin.stockmann@charite.de0049030450552001

Outcome results

None listed

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