| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN58758525 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0265006492 |
| Public title | 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. |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Not Applicable: Liver allograf |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Not provided at time of registration |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/2004 |
| Anticipated end date | 01/01/2007 |
| Status of trial | Completed |
| Target number of participants | 60 |
| Interventions | Sixty 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | University Hospital Birmingham NHS Trust
|
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Prof P McMaster |
| Contact details | Liver Surgery
Queen Elizabeth Hospital
Birmingham
United Kingdom
B15 2TH |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN58758525 |
| Date last extracted from ISRCTN register | 17/04/2008 |
