Clinical trial NCT00295594: Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation.
Official title: An Open, Randomised, Multicenter, Clinical Study to Compare the Safety and Efficacy of Tacrolimus and Minimal Steroids in Combination With Either a Monoclonal Anti-IL2R Antibody (Daclizumab) or Mycophenolate Mofetil in Liver Allograft Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Transplantation
Keywords: Tacrolimus
Liver Transplantation
Treatment Outcome
Immunosuppression
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-02-24
Enrollment: 627
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.

Detailed description: This prospective randomised trial which combines MMF with tacrolimus and so avoids steroids in immunosuppressive maintenance could demonstrate alternatives to current immunosuppressive regimens. There is evidence that reduced steroid usage could further decrease the onset of diabetes mellitus, hypertension and viral infections combined with high efficacy for patients and graft survival. Since the use of MMF in liver transplantation is becoming an alternative in the rescue setting this could contribute to a steroid-free immunosuppressive approach.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older who will undergo primary orthotopic liver or split liver allograft transplantation are eligible for the study. Patients receiving a liver transplant from cadaveric heart-beating donor with compatible AB0 blood type can be included.

Exclusion Criteria:

* Recipient of an auxiliary graft
* Patient is requiring initial sequential or parallel therapy with other immunosuppressive antibody preparation(s).
* Patient is requiring ongoing dosing with corticosteroids.
* Patient is exhibiting symptoms of, or is having any previous history of neoplastic disease
* Patient or donor is known to be HIV positive.
* Patient is allergic or intolerant to study medication

Primary outcomes:
measure: Incidence of and time to first biopsy proven acute rejection which requires treatment within 3 months following transplantation
timeFrame: 3 months
Secondary outcomes:
measure: Acute rejection. Incidence of and time to first acute rejection. Incidence of and time to first corticosteroid-resistant acute rejection.
timeFrame: 3 months
Other outcomes:
Locations:
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Copenhagen
country: Denmark
city: Helsinki
country: Finland
city: Bonn
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Kiel
country: Germany
city: Mainz
country: Germany
city: Budapest
country: Hungary
city: Bari
country: Italy
city: Bergamo
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Udine
country: Italy
city: Szczecin
country: Poland
city: Wroclaw
country: Poland
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: Granada
country: Spain
city: La Coruna
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Pamplona
country: Spain
city: Santiago
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Goteborg
country: Sweden
city: Uppsala
country: Sweden
city: Bern
country: Switzerland
city: Zurich
country: Switzerland
city: Leeds
country: United Kingdom
city: Newcastle
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Medical Physician
role: STUDY_DIRECTOR
References: