Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mr Abdel Hammad


Contact details

9C Link
Renal Transplant Unit
Royal Liverpool University Hospital
Prescot Street
L7 8XP
United Kingdom
+44 (0)151 706 2664

Additional identifiers

EudraCT number number

Protocol/serial number


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


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


End stage renal failure patients undergoing renal transplantation.


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



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


Overall trial end date


Reason abandoned


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Royal Liverpool University Hospital
L7 8XP
United Kingdom

Sponsor information


Royal Liverpool Hospital NHS Trust (UK)

Sponsor details

Prescot Street
L7 8XP
United Kingdom
+44 (0)151 706 2000

Sponsor type




Funder type


Funder name

Roche Products Limited (Ref: 00100674/14807)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name


Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype



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

Publication citations

Additional files

Editorial Notes

11/10/2016: No publications found, verifying study status with principal investigator.