Condition category
Surgery
Date applied
30/03/2005
Date assigned
10/05/2005
Last edited
01/02/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Christopher Watson

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2005-001496-35

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Rituxicam2005

Study hypothesis

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

Huntingdon Research Ethics Committee, ref 05/Q0104/144, date 19/12/2005.

Study design

Single centre randomised controlled open label study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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 names

Rituximab, daclizumab

Primary outcome measures

1. Acute rejection incidence
2. Acute rejection severity - Banff scale
3. Incidence of steroid resistant rejection, defined as the need for ATG therapy

Secondary outcome measures

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

Overall trial start date

01/04/2006

Overall trial end date

31/03/2014

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

Patients undergoing renal transplantation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

Age under 18 years

Recruitment start date

01/04/2006

Recruitment end date

31/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of Surgery
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Roche Products Limited (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cambridge Transplant Unit (UK)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19535812

Publication citations

  1. Results

    Clatworthy MR, Watson CJ, Plotnek G, Bardsley V, Chaudhry AN, Bradley JA, Smith KG, B-cell-depleting induction therapy and acute cellular rejection., N. Engl. J. Med., 2009, 360, 25, 2683-2685, doi: 10.1056/NEJMc0808481.

Additional files

Editorial Notes