Please select the eligibility criteria that correspond to the clinical trial below.
Title: Open, Single Center, Randomised, Parallel Group Pilot Study to Investigate a Calcineurin Free Immunosuppressive Treatment for de Novo Renal Transplant Recipients: A Comparison of a Rapamycin/MMF/Steroids Regime to a Cyclosporine A Neoral/MMF/Steroids Regimen in the Prevention of Acute Rejection Following Renal Transplantation
Brief Summary: The main purpose of this study is to obtain preliminary information on the efficacy, safety and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF / steroid therapy, used in the prevention of acute rejection following renal transplantation.


Options:
A: Inclusion Criteria:

* Male or female patients between 15 and 75 years of age, regardless of race.
* Female patients of child bearing age agree to maintain effective birth control practice during the study.
* Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation as assessed by the transplantation center.
* Patient has been fully informed and has given written or independent person witnessed oral informed consent.

Exclusion Criteria:

* Patient is pregnant or breastfeeding.
* Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.
* Patient has a high immunological risk constellation, defined as having within the previous three years a measured PRA grade of ≥25% and/or having a previous graft survival shorter than 3 years due to rejection.
* Patient and donor have a positive T or B-cell crossmatch.
* Patient and donor are ABO incompatible.
* Age of donor \> 68 years.
* Cold ischemia time \> 36 hours.
* Patient has leucopenia, defined as having at transplantation less than 3000/mm3 leukocytes.
* Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.
* Patient is allergic or intolerant to cremophor RH 60 or structurally related compounds, steroids, Cyclosporine A Neoral, Rapamycin or MMF.
* Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s).
* Patient or donor is known to be HIV positive.
* Patient has significant liver disease, defined as having during the past 28 days continuously ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 fold of the upper value of the normal range of the investigational site.
* Patient with malignancy or history of malignancy ≥ 2 years, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
* Patient has significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.
* Patient is taking or has been taking an investigational drug in the past 28 days.
* Patient has previously received or is receiving another organ transplant other than kidney.
* Patient is unlikely to comply with the visits schedule in the protocol.
B: Inclusion Criteria:

* Age \>14 years
* Weight \> 40 kg
* Primary renal allograft: cadaveric or mismatched living donor
* Negative standard cross match for T-cells
* Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception throughout the study period and for 3 months after discontinuation of study medication (3yrs, 3 mos.)
* Signed and dated informed consent (Parent or legal guardian must provide written consent for patients \<18 years of age)

Exclusion Criteria:

* Evidence of systemic infection
* History of malignancy within 10 years (with the exception of localized skin cancer)
* Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase
* Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole
* Known hypersensitivity to sirolimus and its derivatives
* Patients with a screening/baseline (or within 96 hours of transplant)

  * total white blood cell count \< 4000/mm3;
  * platelet count \< 100,000/mm3;
  * fasting triglycerides \> 400 mg/dl (\> 4.6 mmol/L);
  * fasting total cholesterol \> 300 mg/dl (\> 7.8 mmol/L);
  * fasting HDL-cholesterol \< 30 mg/dl;
  * fasting LDL-cholesterol \> 200mg/dl
C: Inclusion Criteria:

* Male and female patients of any race between 18 to 70 years old (inclusive)
* Patients who gave written informed consent to participate in the study

Exclusion Criteria:

* Recipients of multi-organ transplantation
* Recipients of a primary cadaveric or primary non-human leucocyte antigen (HLA) identical living donor kidney transplantation.
* Graft cold ischemia time greater than 40 hours.

Other protocol-defined inclusion/exclusion criteria may apply.
D: Inclusion Criteria:

* Dialysis patients who will be receiving their first kidney transplant
* Weight over 88 pounds (lbs.)

Exclusion Criteria:

* Very high cholesterol levels
* Obesity
* Organ donor over 65 years of age if living; over 60 years of age if cadaveric.

Answer: A