|
Welcome
|
|
11 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public 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 |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | 101177/ML17309 |
| 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.
The 3 year follow up was completed on 24/06/2009 |
| Lay summary | |
| Ethics approval |
Liverpool Research Ethics Committee on 06/11/2002
LREC Ref No: 02/07/124/A |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | End stage renal failure patients undergoing renal transplantation. |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 26/11/2002 |
| Anticipated end date | 10/06/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 40 from each site - total of 80 |
| Interventions |
Cyclosporin, Mycophenolate Mofetil and steroids in the control arm of the trial.
Active arm patients received Sirolimus, Mycophenolate Mofetil, steroids and Daclizumab induction. |
| Primary outcome measure(s) | 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 measure(s) |
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) |
| Sources of funding |
Commercial sources of funding from:
Roche Products Limited (Ref: 00100674/14807) Wyeth Pharmaceuticals Limited |
| Trial website | |
| Publications | |
| Contact name | Mr Abdel Hammad |
| Address |
9C Link
Renal Transplant Unit Royal Liverpool University Hospital Prescot Street |
| City/town | Liverpool |
| Zip/Postcode | L7 8XP |
| Country | United Kingdom |
| Tel | +44 (0)151 706 2664 |
| Fax | +44 (0)151 706 5819 |
| abdul.hammad@rlbuht.nhs.uk | |
| Sponsor | Royal Liverpool Hospital NHS Trust (UK) |
| Address | Prescot Street |
| City/town | Liverpool |
| Zip/Postcode | L7 8XP |
| Country | United Kingdom |
| Tel | +44 (0)151 706 2000 |
| Fax | +44 (0)151 706 5806 |
| gill.sims@rlbuht.nhs.uk | |
| Sponsor website: | http://www.rlbuht.nhs.uk |
| Date applied | 13/09/2005 |
| Last edited | 11/01/2011 |
| Date ISRCTN assigned | 17/10/2005 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|