Please select the eligibility criteria that correspond to the clinical trial below.
Title: Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant - Randomised Withdrawal of Mycophenolate Mofetil (CellCept®) or Cyclosporine A (Sandimmun Neoral®)
Brief Summary: To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy


Options:
A: 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.
B: Inclusion Criteria:

* At least 18 years of age and able to give informed consent
* African-American ethnicity
* Received a first or second non-ECD cadaveric or living donor renal transplant
* Transplant occurred during the past 6 to 24 weeks
* Patient has stable graft function, defined as no change of greater than 30% of baseline serum creatinine during the past month and no acute rejection in the past 6 weeks
* Estimated GFR using the modified MDRD equation of at least 40 mL/min10 at time of enrollment into the study
* Currently receiving tacrolimus, mycophenolate mofetil (at least 1 gm per day), and corticosteroids as their immunosuppression regimen.

Exclusion Criteria:

* Biopsy proven acute rejection episode that occurred within the past 6 weeks
* Malignancy within the past 3 years, except for non-melanoma skin cancer
* Any known intolerances to current immunosuppressant regimen necessitating withdrawal of the offending agent
* Currently enrolled in an investigational trial
* Woman of child bearing potential not utilizing an effective form of birth control
* Patients with uncontrolled dyslipidemia, defined at serum fasting LDL \>200 mg/dL or serum fasting triglycerides \>500 mg/dL.
* Patients with a spot urine protein to creatinine ratio of \> 800 mg of protein per gram of creatinine.
* WBC \< 3,000 cells/mm3
* Platelets \< 100,000 cells/mm3
C: Inclusion Criteria:

* Primary or secondary kidney transplant
* Treatment with mycophenolic acid (MMF 1 g/d or EC-MPS 720 mg/d) and tacrolimus (trough concentration \[C0\] ≥ 5.5 ng/mL)
* Creatinine clearance ≥ 30 mL/min and \< 60 mL/min and stable renal function

Exclusion Criteria:

* Multi-organ recipients or previous transplant with any other organ different from kidney
* Biopsy proven acute rejection or treated acute rejection within the last 3 months.
* Prescription of mycophenolate mofetil 1 g/d or mycophenolate sodium 720 mg/d due to adverse event occurrence when higher doses were administered

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

* 1. Patients of either gender above 18 years of age at time of randomisation. 2. More than twelve months posttransplant. 3. Treated with an immunosuppressive protocol consisting of CsA, MMF and steroid from the time of discharge from the transplant clinic (e.g. 3 months posttransplant).

  4. Kidney (only) transplant recipients with stable renal function (S-creatinine \< 300 umol/L and an average increase in S-creatinine \< 20% the last 6 months prior to inclusion) and without treated clinically and/or biopsy proven acute rejection episodes the last 6 months prior to inclusion.

  5. No previous steroid resistant acute rejections (e.g. treated with ATG/OKT3). 6. Not more than two steroid sensitive acute rejections posttransplant. 7. Signed informed consent.

Exclusion Criteria:

- 1. PRA positivity \> 20%. 2. Concomitant therapy with other investigational drugs or prohibited medication specified in the protocol.

3. Life expectancy less than one year. 4. Acute illness or acute fungal, bacterial or viral infection at screening. 5. Unable and/or unlikely to follow the study protocol.

Answer: D