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 |
| Protocol serial number | N0265006492 |
| Sponsor | Department of Health |
| Funder | University Hospital Birmingham NHS Trust (UK) |
- 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
Scientific
Liver Surgery
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Methotrexate |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Liver Surgery
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
