Condition category
Urological and Genital Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
17/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes