Renal Transplantation MedDRA version: 9.1 Level: PT Classification code 10038533 Term: Renal transplant
Conditions
Interventions
Trade Name: Rapamune
Product Name: Rapamune
Product Code: Not available
Pharmaceutical Form: Tablet
INN or Proposed INN: SIROLIMUS
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The enrolled patients must fulfil the following inclusion criteria: 1. Male and female patients between 18 and 75 years of age 2. Patients scheduled for a single-organ, renal transplantation from living or deceased donors. Patient receiving second renal transplants can be included, provided that the previous graft was not lost from acute rejection within the first year. 3. Patients capable of understanding the purposes and risks of the study, who give written informed consent and who are willing to participate to and comply with the study. 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: The following groups of patients will not be included in the study: 1. Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method before beginning study drug therapy, during therapy and for 4 months following their last dose of the drugs administered within this clinical study. 2. Patients receiving the third or higher renal transplant. 3. Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy. 4. Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study. 5. Patients with evidence of an active systemic infection requiring the continued use of antibiotics or evidence of an HIV infection, or the presence of a chronic active hepatitis B (HBs-Ag positive) or C. 6. Patients with history of malignancy (except successfully treated localized non-melanistic skin cancer). 7. Patients with active peptic ulcer disease. 8. Patients with evidence of an active liver disease 9. Patients with severe anemia (Hb 30% within 6 months prior to enrollment; 13. Cold ischemia time of the graft of more than 30 hours; 14. Patients who had received an investigational new drug within the last three months. 15. Patients previously treated with daclizumab or basiliximab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy parameter of the study is to compare the change in bone density between 6 weeks and 12 month post transplant between groups A & B.;Main Objective: The primary objective of the present investigation is to evaluate the effect of sirolimus (converted from ciclosporin at 6 weeks) compared to cicolsporin, as part of a standard immunosuppressive regimen, on the severity of bone loss at 12 months post transplant. . Current standard immunosuppression (group A: mycophenolate mofetil, dacluzimab, ciclosporin and corticosteroids) will be compared to a CNI conversion regimen (group B: mycophenolate mofetil, dacluzimab, ciclosporin converted to sirolimus at 6 weeks, and corticosteroids).; Secondary Objective: Secondary objectives are: • To assess the tolerability of patients to the regimens, by recording the % of patients remaining CNI free at 12 months. • Evaluate the incidence of biopsy proven, type and severity of rejection • To characterize the safety (hypertension, hyperlipidemia, opportunistic infections, post transplant and diabetes mellitus) of the immunosuppressant combinations at 6 and 12 months. • To evaluate the renal function as expressed by the calculated creatinine clearance over the course of the study. • Assess the impact of CNI conversion to sirolimus on MPA AUC in 10 patients in group B. | — |
Countries
United Kingdom
Outcome results
None listed