A Phase II Randomised Study of the Addition of Methotrexate 0.05 mg/kg 12 hourly for 8 doses to the Current Immunosuppressant Regimen for the Prevention of Liver Allograft Rejection.

ISRCTN	ISRCTN58758525
DOI	https://doi.org/10.1186/ISRCTN58758525
Secondary identifying numbers	N0265006492

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 13/03/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof P McMaster
Scientific

Liver Surgery
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Not Specified
Scientific title
Study objectives	Two thirds of patients receiving an orthotopic liver allograft suffer acute graft rejection episodes within the first few weeks post transplant despite current immunosuppressant therapy. This deficiency in current therapy necessitates the administration of high dose steroids in these patients, in a smaller proportion is associated with early graft loss and may in other patients be associated with graft loss from the subsequent development of a chronic graft rejection process. The aim of the proposed trial is to assess the safety and efficacy of the addition to current immunosuppressant therapy of 0.05mg/kg methotrexate given 12 hourly for four days from 24 hours post transplant. The rationale for this therapeutic strategy lies in its common application to the prevention of graft versus host disease after allogeneic bone marrow transplantation; the efficacy of methotrexate in treating established rejection episodes in cardiac allografts; the efficacy of methotrexate in preventing organ allograft rejection in experimental animals.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Not Applicable: Liver allograf
Intervention	60 consecutive adult patients who have previously consented to participate in the trial will be randomised to one of two treatment groups at the time of liver transplantation. The treatment groups are 'standard' or 'standard / methotrexate' immunosuppressant regimen. The two treatment groups will be assessed for: 1. Adverse effects attributable to their immunosuppressant therapy 2. Incidence and severity of early graft rejection episodes 3. Use of additional immunosuppressant drugs, particularly corticosteroids 4. Incidence of late acute graft rejection episodes and incidence of chronic graft rejection.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Methotrexate
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2004
Completion date	01/01/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	60
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2004
Date of final enrolment	01/01/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Liver Surgery

Birmingham
B15 2TH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

University Hospital Birmingham NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan