Contact information
Type
Scientific
Primary contact
Mr Abdel Hammad
ORCID ID
Contact details
9C Link
Renal Transplant Unit
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
+44 (0)151 706 2664
abdul.hammad@rlbuht.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
101177/ML17309
Study information
Scientific title
A randomised prospective trial of daclizumab induction followed by sirolimus in association with mycophenolate mofetil and steroids versus standard cyclosporin based triple therapy for rejection prophylaxis in renal transplantation
Acronym
Study hypothesis
A calcineurin inhibitor (CNI) free regimen offers equivalent safety and efficacy to that of a CNI regimen and may offer improved long-term graft survival.
Ethics approval
Liverpool Research Ethics Committee, 06/11/2002, ref: 02/07/124/A
Study design
Randomised controlled trial
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 contact details to request a participant information sheet
Condition
End stage renal failure patients undergoing renal transplantation.
Intervention
Cyclosporin, Mycophenolate Mofetil and steroids in the control arm of the trial.
Active arm patients received Sirolimus, Mycophenolate Mofetil, steroids and Daclizumab induction.
Intervention type
Drug
Phase
Not Applicable
Drug names
Daclizumab, Sirolimus, Mycophenolate Mofetil, Cyclosporin
Primary outcome measures
To determine whether a CNI free regimen provides improved renal function at 6 and 12 months post-transplant as compared with a conventional Cyclosporin based regimen in renal transplant patients. This will be assessed by comparing the differences in renal function between the groups, as measured by a creatinine clearance (calculated glomerular filtration rate [GFR], Cockroft & Goult).
Secondary outcome measures
To compare the impact of a CNI free regime, if any, on:
1. Subsequent transplant outcome
2. Patient and graft survival
3. Infectious complications
4. Post-transplant malignancies
To compare the impact of a CNI free regime if any on:
1. Rejection rates at 6 & 12 months post-transplantation
2. Incidence and rate of recovery of post-transplant acute tubular necrosis
3. Incidence of drug-induced side-effects
4. Incidence and severity of post-transplant hypertension
5. Vascular endothelial growth factor (VEGF) expression in relation to graft survival and malignancy (Manchester data only)
Overall trial start date
26/11/2002
Overall trial end date
24/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients must be over age 18
2. Patients must be recipients of a first, second or subsequent kidney transplant from a cadaveric or HLA mismatched live donor
3. Patients receiving a second or subsequent transplant must have maintained their primary graft for a minimum of 6 months, except if graft failure was due to technical reasons
4. Written informed consent
5. Women of childbearing potential must have a negative pregnancy test before commencing the trial and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuing the trial
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 from each site - total of 80
Participant exclusion criteria
1. Known hypersensitivity to any of the study drugs
2. Prohibited prior or concomitant medications
3. Pregnant women or nursing mothers
4. White blood cell count (WBC) count <3000/mm^3 or platelets <75,000/mm^3 at time of study entry
5. Fasting cholesterol >7.8 mmol/l or triglycerides >4.6 mmol/l
6. Human immunodeficiency virus (HIV) postitive, Hepatitis B or C, history of alcoholism or drug abuse
7. Patients with known prior malignancies, except completely excised and localised non-melanoma skin cancers
8. Evidence of infiltrate, cavitation or consolidation on chest X-ray (CXR) obtained during pre-study screening
9. Recipients of marginal donor kidneys such as paediatric < age 2, terminal serum creatinine >220 µmol/l, preservation time >48 hours, recipients of adult dual kidney transplants
10. Current participation in another trial or participation in another trial within the last 30 days
11. Highly sensitised recipients according to plasma renin activity (PRA) >50%
12. Any other concurrent cardiovascular, gastrointestinal, pulmonary or haematological conditions that would restrict the administration of Cyclosporin, Sirolimus, Mycophenolate, steroids or antilymphocytic agents, in the opinion of the Investigator
Recruitment start date
26/11/2002
Recruitment end date
10/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Liverpool University Hospital
Liverpool
L7 8XP
United Kingdom
Sponsor information
Organisation
Royal Liverpool Hospital NHS Trust (UK)
Sponsor details
Prescot Street
Liverpool
L7 8XP
United Kingdom
+44 (0)151 706 2000
gill.sims@rlbuht.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Roche Products Limited (Ref: 00100674/14807)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Wyeth
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
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