de novo Renal Allograft Recipients
Conditions
Interventions
Trade Name: Rapamune Tablets 1mg
Product Name: Rapamune
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Sirolimus
CAS Number: 53123-88-9
Other descriptive name: Rapamycin
Concentration unit: m
Sponsors
Wyeth Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age >= 18 years End stage renal disease with subjects scheduled to reciev a primary or secondary renal allograft from a cadaveric, living unrelated, or a living related donor. A minimum of 1 HLA match is required. Negative pregnancy test and women of childbearing potential must agree to use a medically accepted method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment. Signed and dated informed consent form. 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: Evidence of active systemic or localized major infection. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during baseline/screening evaluation. Use of any investigational drug or treatment up to 4 weeks prior to randomization. Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, daclizumab, TAC, or MMF. Multiple organ transplants (i.e. prior or concurrent transplantation or any organs other than renal transplant.) Immunosuppressive therapies othe than those described in section 15. Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole that is not discontinued prior to randomization. Treatment with aminoglycosides, amphotericin B, cisplatin, or other drugs associated with renal dysfunction that is not discontinued prior to randomization. Subjects who, in the opinion of the investigator, are at high risk for acute rejection. Cold ischemia time of donor kidney greater than 30 hours. Subjects with a screening/baseline total white blood count = 400 mg/dl; fasting total cholesterol >= 300 mg/dL. History of malignancy within 5 years before enrollment (except for adequately treated basal cell or squamous cell carcinoma of the skin.) Planned use of agents with a known major interaction with SRL, TAC, or MMF. Subjects with active Hepatitis B (surface antigen, HBV DNA or e antigen positive) or active Hepatitis C (antibody positive). Subjects may be considered to have inactive disease, however, if Hepatitis C antibody positive buy PCR negative prior to screening. Subjects who are known to be HIV positive. Subjects with a Body Mass Index (BMI) > 34 kg/m2. Recipients of adult or pediatric en block kidney transplant. Recipients of zero HLA mismatches. Recipients of non-heart beating donor kidney transplants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at 12 months.;Secondary Objective: To evaluate the safety of all three regimens.;Primary end point(s): Calculated creatinine clearance (Nankivell method) at 12 months after transplant. | — |
Countries
Spain
Outcome results
None listed