A randomised controlled trial comparing the use of sirolimus based biphasic immunosuppression with myfortic to allow early CalciNeurin Inhibitor (CNI) withdrawal in renal transplantatio

Completed

• Conditions: Renal transplantation; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN76390219
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Patients will be eligible for the trial if all of the following criteria are met:
1. Age greater than or equal to 18 years
2. Patients receiving a primary or secondary renal allograft from a living related, living unrelated or heart-beating cadaveric donor
3. Patients with second transplants must have maintained their primary graft for at least six months after transplantation (with the exception of graft failure due to technical reasons)
4. Stable renal allograft function over the first 3 months post transplant
5. An absence of subclinical rejection on the 3 month protocol biopsy
6. A negative pregnancy test pre-protocol biopsy
7. Signed written informed consent

Exclusion Criteria

Patients will not be eligible for the trial if any of the following criteria apply:
1. Kidney transplantation from a non heart-beating donor
2. Patients suffering an acute rejection episode in the first 3 months post transplant with a Banff classification of 1b or above
3. Sub-clinical rejection seen in the 3-month protocol biopsy
4. Proteinuria >500 mg/24 hours
5. Estimated Glomerular Filtration Rate (eGFR) <40 mls/min (Cockcroft-Gault formula)
6. Evidence of active systemic or localised major infection at study entry
7. Known hypersensitivity to Tacrolimus, macrolide antibiotics or Myfortic
8. Use of any investigational drug or treatments within 28 days before study entry
9. Known or suspected malignancy within five years before study entry
10. Any condition which in the opinion of the investigator makes the patient unsuitable for entry into the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Renal allograft fibrosis at 6 months post-trial entry<br>2. Renal function as measured by change in the slope of the eGFR over a period of at least 2 years (least squares method)

Secondary Outcome Measures

Name	Time	Method
1. Change in cystatin C concentrations at 6 and 12 months compared to baseline<br>2. Incidence of biopsy proven acute rejection. The diagnosis and graded severity of acute renal allograft rejection will be made by employing the 1997 Banff criteria<br>3. Renal allograft profibrotic gene expression determined by Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)<br>4. Patient and graft survival at 6, 12 and 24 months post-trial entry<br>5. Comparison of blood pressure and the requirements for anti hypertensive therapy<br>6. Comparison of hyperlipidaemia (to include cholesterol, triglycerides, Low Density Lipoprotein [LDL] and High Density Lipoproteins [HDL]) and the requirement for treatment of elevated lipids<br>7. Proteinuria assessed by 24 hour urinary protein at 3, 6 and 12 months<br>8. Quality of life differences on the 36-item Short Form health survey (SF-36) at 6 and 12 months compared to baseline