Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation. - Full Text View

Purpose

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.

Condition	Intervention	Phase
Liver Transplantation	Drug: tacrolimus	Phase III

MedlinePlus related topics:

Liver Transplantation

Drug Information available for:

Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous Dacliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Incidence of and time to first biopsy proven acute rejection which requires treatment within 3 months following transplantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Acute rejection. Incidence of and time to first acute rejection. Incidence of and time to first corticosteroid-resistant acute rejection. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	627
Study Start Date:	March 2005
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: tacrolimus Immunosuppression
2: Experimental	Drug: tacrolimus Immunosuppression

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295594

Show 41 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Director:	Medical Physician	Astellas Pharma Europe

More Information

Link to FDA website This link exits the ClinicalTrials.gov site

Responsible Party:	Astellas Pharma Europe BV ( Astellas Disclosure Office )
Study ID Numbers:	FG-506-01-27
First Received:	February 22, 2006
Last Updated:	December 31, 2007
ClinicalTrials.gov Identifier:	NCT00295594
Health Authority:	Switzerland: Swissmedic