Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids
Condition: Inflammation
MeSH terms: Inflammation
Intervention: CsA+Rapamune+CS; CsA+MMF+CS
Intervention description: Part 1: Rapamune will be given as a loading dose of 6 mg once followed by maintenance dose of 2 mg to achieve a target trough level of 8-15 ng/ml. Part 2: Rapamune dose will be adjusted to achieve a target trough level of 10-15ng/ml through 6 months; The control arm is the standard local practice (official protocol) in Iran:
Cyclosporine + MMF + Corticosteroid. The time period is from pre-study screening / baseline evaluation up to 12 months for patients who are maintained on CsA + MMF + CS.
Intervention MeSH terms: Sirolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 245.0
Sex: All
Minimum age: 13 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) +
      corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the
      introduction of MMF in de novo renal allograft recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 13 years and weight 40 kg

          -  End-stage renal disease, with patients receiving a primary or secondary renal
             allograft from a living-unrelated donor, or from a living-related donor.

          -  Women who are of childbearing potential must have a negative pregnancy test before
             enrollment in the study and agree to use a medically acceptable method of
             contraception throughout the treatment period and for 3 months following
             discontinuation from the study.

          -  Total white blood cell count 4.0 x 109/L (4,000/mmP3P), platelet count 100 x
             10P9P/L(100,000/mmP3P), fasting triglycerides ≤ 4.6 mmol/L (400 mg/dL), fasting
             cholesterol ≤ 7.8 mmol/L (300 mg/dL). If it is not possible to obtain fasting
             triglycerides and cholesterol before surgery, historical values (within 1 year) may be
             used.

          -  Signed and dated informed consent (parent or legal guardian must provide consent for
             patients <18 years of age). An assent form will be signed by patients < 18 years of
             age enrolled in the study.

        Exclusion Criteria:

          -  Evidence of active systemic or localized major infection at the time of initial
             Sirolimus administration.

          -  Cadaveric donors

          -  History of malignancy within 5 years before enrollment into the study (with the
             exception of adequately treated basal cell or squamous cell carcinoma of the skin)

          -  Use of any investigational drug other than specified in the protocol during the 4
             weeks before enrolling in the study.

          -  Use of planned antibody induction therapy at the time of transplantation.

          -  Active gastrointestinal disorder that may interfere with drug absorption.

          -  Known hypersensitivity to Sirolimus, MMF or Cyclosporine or its derivatives.

          -  Multiple organ transplants (2 or more organ transplant e.g. Kidney and Pancreas).

          -  Patient with high risk of rejection (eg. Patients with a PRA >50%, black patients and
             patients with 2nd transplant who lost their first graft within the first 6 months).

          -  Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during
             pre-study screening