Condition category
Urological and Genital Diseases
Date applied
13/09/2005
Date assigned
17/10/2005
Last edited
11/10/2016
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

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

http://www.rlbuht.nhs.uk

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

Publication citations

Additional files

Editorial Notes

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