Contact information
Type
Scientific
Primary contact
Dr Adam McLean
ORCID ID
Contact details
HHNT Renal Unit
4th Floor Hammersmith House
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)208 383 5152
amclean@hhnt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00246129
Protocol/serial number
N0016188158
Study information
Scientific title
A randomised controlled comparison of Campath-Tacrolimus vs IL2R MoAb-Tacrolimus/Mycophenolate as induction-Maintenance immunosuppression in kidney transplantation (protocol SMHREN0501)
Acronym
Study hypothesis
To determine which of two well established anti-rejection drug combinations has the best outcome in kidney transplantation.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled open study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Urological and Genital Diseases: Kidney transplant
Intervention
Randomised controlled open study
Intervention type
Drug
Phase
Not Applicable
Drug names
Campath-Tacrolimus
Primary outcome measures
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 trial start date
01/12/2005
Overall trial end date
01/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Adults undergoing liver donor or deceased donor kidney transplantation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
01/12/2005
Recruitment end date
01/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hammersmith Hospital
London
W12 0HS
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)207 307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hammersmith Hospital NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
St Mary's Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21836540