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

ISRCTN	ISRCTN74336394
DOI	https://doi.org/10.1186/ISRCTN74336394
Secondary identifying numbers	101177/ML17309

Submission date: 13/09/2005
Registration date: 17/10/2005
Last edited: 11/10/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

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 Abdel Hammad
Scientific

9C Link
Renal Transplant Unit
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom

Phone	+44 (0)151 706 2664
Email	abdul.hammad@rlbuht.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
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 objectives	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(s)	Liverpool Research Ethics Committee, 06/11/2002, ref: 02/07/124/A
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Daclizumab, Sirolimus, Mycophenolate Mofetil, Cyclosporin
Primary outcome measure	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 study start date	26/11/2002
Completion date	24/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40 from each site - total of 80
Key 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
Key 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
Date of first enrolment	26/11/2002
Date of final enrolment	10/06/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Liverpool University Hospital

Liverpool
L7 8XP
United Kingdom

Sponsor information

Royal Liverpool Hospital NHS Trust (UK)
Hospital/treatment centre

Prescot Street
Liverpool
L7 8XP
England
United Kingdom

Phone	+44 (0)151 706 2000
Email	gill.sims@rlbuht.nhs.uk
Website	http://www.rlbuht.nhs.uk
"ROR"	https://ror.org/009sa0g06

Funders

Funder type

Industry

Roche Products Limited (Ref: 00100674/14807)

No information available

Wyeth
Private sector organisation / For-profit companies (industry)

Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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