A randomised controlled comparison of Campath-Tacrolimus vs IL2R MoAb-Tacrolimus/Mycophenolate as induction-Maintenance immunosuppression in kidney transplantation (protocol SMHREN0501)
| ISRCTN | ISRCTN73171002 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73171002 |
| ClinicalTrials.gov number | NCT00246129 |
| Secondary identifying numbers | N0016188158 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 17/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Adam McLean
Scientific
Scientific
HHNT Renal Unit
4th Floor Hammersmith House
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
| Phone | +44 (0)208 383 5152 |
|---|---|
| amclean@hhnt.nhs.uk |
Study information
| Study design | Randomised controlled open study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled comparison of Campath-Tacrolimus vs IL2R MoAb-Tacrolimus/Mycophenolate as induction-Maintenance immunosuppression in kidney transplantation (protocol SMHREN0501) |
| Study objectives | To determine which of two well established anti-rejection drug combinations has the best outcome in kidney transplantation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Kidney transplant |
| Intervention | Randomised controlled open study |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Campath-Tacrolimus |
| Primary outcome measure | 1. An understanding of the merits of these two anti-rejection treatment combinations. 2. One year survival with a functioning graft |
| Secondary outcome measures | 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 |
| Overall study start date | 01/12/2005 |
| Completion date | 01/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | Adults undergoing liver donor or deceased donor kidney transplantation |
| Key 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 |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 01/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hammersmith Hospital
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)207 307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
Hammersmith Hospital NHS Trust
No information available
St Mary's Hospital
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/10/2011 | Yes | No |
