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 transplantatio

Not Applicable

Completed

• Conditions: End stage renal failure patients undergoing renal transplantation.; Urological and Genital Diseases; Renal failure

• Registration Number: ISRCTN74336394
• Lead Sponsor: Royal Liverpool Hospital NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-17
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified