Chronic Allograft Nephropathy MedDRA version: 8.1 Level: LLT Classification code 10063209 Term: Chronic allograft nephropathy
Conditions
Interventions
Trade Name: Rapamune
Product Name: Rapamune
Pharmaceutical Form: Coated tablet
Trade Name: Prograf
Pharmaceutical Form: Capsule, hard
Trade Name: Myfortic
Pharmaceutical Form: Coated tablet
Trade N
Sponsors
University Hospitals Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
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. Signed written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 >500mg/24hours 5. eGFR <40mls/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess surrogate markers of chronic allograft nephropathy: 1. Renal allograft fibrosis at 6 months post-trial entry. (% area fibrosis and profibrotic gene expression). 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 Objective: To compare efficacy of the two therapies: 1. Change in cystatin C concentrations at 6 and 12 months compared to base line. 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. 3. Renal allograft profibrotic gene expression determined by RT-PCR. 4. Patient and graft survival at 6 and 12 6,12, and 24 months post-trial entry. 5. Comparison of blood pressure and the requirements for anti hypertensive therapy. 6. Comparison of hyperlipidaemia (to include cholesterol, triglycerides, LDL and HDL) and the requirement for treatment of elevated lipids. 7. Proteinuria assessed by urinary:creatinine ratio at 6 and 12 months compared to base line. ?24hr uninary protein as prev. literature 8. Quality of life differences on the SF36 at 6 and 12 months compared to base line. ;Primary end point(s): Primary End Points 1. Change in Renal transplant fibrosis at 6 months post-trial entry. 2. Renal function as measured by change in the slope of the eGFR over a period of at least 2 years (least squares method). | — |
Countries
United Kingdom
Outcome results
None listed