A single centre, randomised controlled, open label study of rituximab as induction therapy in kidney transplantation

ISRCTN	ISRCTN07963178
DOI	https://doi.org/10.1186/ISRCTN07963178
Clinical Trials Information System (CTIS)	2005-001496-35
Protocol serial number	N/A
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funders	Roche Products Limited (UK), Cambridge Transplant Unit (UK)

Submission date: 30/03/2005
Registration date: 10/05/2005
Last edited: 19/09/2017

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Surgery

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

Mr Christopher Watson
Scientific

Dept of Surgery
Box 202
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Study information

Primary study design	Interventional
Study design	Single centre randomised controlled open label study
Secondary study design	Randomised controlled trial
Scientific title	A single centre, randomised controlled, open label study of rituximab as induction therapy in kidney transplantation
Study acronym	Rituxicam2005
Study objectives	Primary objective: To evaluate the effect of rituximab compared to daclizumab on the incidence and severity of acute rejection Secondary objectives: To evaluate the effect of rituximab on patient and graft survival following transplantation To evaluate the differences in gene expression patterns in patients immunosuppressed with rituximab compared to daclizumab by microarray analysis
Ethics approval(s)	Huntingdon Research Ethics Committee, ref 05/Q0104/144, date 19/12/2005.
Health condition(s) or problem(s) studied	Immunosuppression following renal transplantation
Intervention	Comparision of rituximab with daclizumab as induction immunosuppression following renal transplantation Added 01/02/2010: The trial was stopped prematurely due to an excess of acute rejection in the study arm.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Rituximab, daclizumab
Primary outcome measure(s)	1. Acute rejection incidence 2. Acute rejection severity - Banff scale 3. Incidence of steroid resistant rejection, defined as the need for ATG therapy
Key secondary outcome measure(s)	1. Patient survival 2. Graft survival 3. Graft function estimated glomerular filtration rate (GFR) 4. Incidence of infection culture positive infections 5. Incidence of C4d+ endothelial staining together with infiltrate on renal biopsy 6. Incidence of anti-donor HLA-specific antibody in post transplant sera
Completion date	31/03/2014
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
Key inclusion criteria	Patients undergoing renal transplantation
Key exclusion criteria	Age under 18 years
Date of first enrolment	01/04/2006
Date of final enrolment	31/03/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Dept of Surgery

Cambridge
CB2 2QQ
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/06/2009		Yes	No

Editorial Notes

19/09/2017: internal review.