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 (NCT)	NCT00246129
Protocol serial number	N0016188158
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	Hammersmith Hospital NHS Trust, St Mary's Hospital

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Adam McLean
Scientific

HHNT Renal Unit
4th Floor Hammersmith House
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Phone	+44 (0)208 383 5152
Email	amclean@hhnt.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled open study
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Campath-Tacrolimus
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
Key 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
Completion date	01/12/2008

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Hammersmith Hospital

London
W12 0HS
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/10/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes