| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN73171002 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0016188158 |
| Public title | A randomised controlled comparison of Campath-Tacrolimus vs IL2R MoAb-Tacrolimus/Mycophenolate as induction-Maintenance immunosuppression in kidney transplantation (protocol SMHREN0501) |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Urological and Genital Diseases: Kidney transplant |
| Study hypothesis | To determine which of two well established anti-rejection drug combinations has the best outcome in kidney transplantation. |
| Design/methodology | Randomised controlled open study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Adults undergoing liver donor or deceased donor kidney transplantation |
| Participants - exclusion criteria | 1. Patients who are unable to give written informed consent
2. Simultaneous kidney/pancreas transplant recipients
3. Non-heart beating deceased donor transplant recipients
3. Patients who would not be offered Campath-1H induction under our current protocol (patients with previous malignancy or with previous exposure to cytotoxic or antiproliferative agents |
| Patient information material |
|
| Anticipated start date | 01/12/2005 |
| Anticipated end date | 01/12/2008 |
| Status of trial | Ongoing |
| Target number of participants | 120 |
| Interventions | Randomised controlled open study |
| Primary outcome measure(s) | 1. An understanding of the merits of these two anti-rejection treatment combinations.
2. One year survival with a functioning graft |
| Secondary outcome measure(s) | 1. Occurrence, severity, and type of infection episodes
2. Initial length of stay in hospital and subsequent admissions
3. Cost over the first year of the two therapies
4. Presence in the blood of cells which might trigger rejection in, or promote tolerance to the graft
5. Early development of scarring in the grafts
6. Graft function
7. Patient survival and graft survival censored for death with function |
| Sources of funding | Hammersmith Hospital NHS Trust
St Mary's Hospital
|
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Adam McLean |
| Contact details | HHNT Renal Unit
4th Floor Hammersmith House
Hammersmith Hospital
Du Cane Road
London
United Kingdom
W12 0HS |
| Contact telephone | +44 020 8383 5152 |
| Contact fax | +44 020 7886 6901 |
| Contact email | amclean@hhnt.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN73171002 |
| Date last extracted from ISRCTN register | 17/04/2008 |
