This study will be conducted in 60 established renal allograft recipients who have suffered from chronic renal failure of any cause.
Conditions
Interventions
Trade Name: Rapamune
Pharmaceutical Form: Tablet
INN or Proposed INN: SIROLIMUS
CAS Number: 53123889
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 1-20
Trade Nam
Sponsors
Newcastle upon Tyne Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i. Male and female patients aged 18 to 75 years. ii. Patients with a calculated creatinine clearance (GFR, Cockcroft & Gault method) of > 40 ml/min and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i. Known hypersensitivity to Rapamune and its derivatives. ii. Evidence of active systemic or localized infection. iii. Current use of cimetidine, terfenedine, astemizole, pimozide or azole anti-fungals (medications to be discontinued at least 24 hours before administration of sirolimus). iv. Baseline fasting cholesterol level > 7.8 mmol/L and or triglycerides > 4.6 mmol/L. v. Know or suspected malignancy within 5 years prior to study entry (with the exception of adequately treated basal cell or squamous cell carcinomas of the skin) or a history of PTLD. vi. Use of any investigational drug or treatments within 30 days before study entry. vii. Multiple organ transplants (e.g. kidney-pancreas) viii. History of alcohol or drug abuse. ix. Previous participation in this trial. x. HIV positive patients xi. Patients with proteinuria >800mg/24 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study will assess whether the conversion from CNI based therapy to Rapamune provides effective immunosuppression but with improved renal function as compared to the standard therapy control group. ;Secondary Objective: 1. Comparison of serum creatinine at 6 and 12 months compared to baseline. 2. To assess the efficacy of the two Groups as measured by the cumulative incidence of biopsy proven acute rejection at 6 and 12 months 3. To assess the cumulative incidence of death, graft loss at 12 months 4. To compare the incidence, and severity of adverse events and serious adverse events at 12 months 5. To compare the diastolic and systolic blood pressure at 6 and 12 months and to compare the use of antihypertensive medication between the two groups.;Primary end point(s): The primary objective of the study is renal function as measured by calculated creatinine clearance (GFR) at 6 and 12 months following conversion and by the comparison of differences between treatment groups as determined by the least squares slopes of 1/creatinine vs. time over 12 months following conversion. | — |
Countries
United Kingdom
Outcome results
None listed