Clinical trial NCT01213394 (phase 3, status: terminated)
Conditions: kidney transplantation, cardiovascular diseases
ICD codes: N26.2, Q63.0, Q63.2, Z52.4, I75.81, N19, N20.0, A52.00, A52.09, A50.54, Z01.810, Q87.418, Z13.6, R94.30
Drugs: mycophenolate mofetil
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O
Reason stopped: 
    poor recruitment.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Renal transplant recipients who are ≥ 6 months post-day of transplant surgery.

          2. Single organ kidney recipient (may be for first or repeat transplant).

          3. Age ≥ 30 years of age as of the Day 0 visit.

          4. Immunosuppressive regimen consisting of a CNI (cyclosporine [CsA, Neoral] or
             tacrolimus [TAC, Prograf or Advagraf], corticosteroids and either MMF (CellCept),
             EC-MPS (Myfortic), AZA (Imuran) or SRL (Rapamune) at the baseline visit. Patients are
             to be maintained on the same dose(s) for at least 4 weeks prior to study enrolment.

          5. If the patient is taking an MPA immunosuppressant at the time of the screening visit,
             the MMF (CellCept) dose must be ≤ 1500 mg/day; or the EC-MPS (Myfortic) dose must be ≤
             1080 mg/day.

          6. Framingham risk factor score that exceeds the low comparative 10-year CHD risk, based
             on age and gender.

          7. Presence of at least one established CV risk factor at baseline warranting
             modification of the immunosuppressive regimen including:

               -  Hypertension: Blood pressure ≥ 140 mmHg systolic and/or ≥ 90 mmHg diastolic
                  and/or requiring ≥ 1 antihypertensive medication.

               -  Diabetes mellitus: Established diabetes requiring treatment with oral
                  hypoglycemic agents or insulin, or known IFG or IGT based on 75-g oral glucose
                  tolerance testing (2003 Canadian Diabetes Association criteria).

               -  Hyperlipidemia: TC ≥ 5.2 mmol/L, or LDL-C ≥ 2.6 mmol/L, or TG ≥ 1.7 mmol/L, or
                  TC:HDL ≥ 4 and/or requiring ≥ 1 anti-hyperlipidemia agent.

          8. Willingness and ability to complete protocol requirements.

          9. Written informed consent.

        Exclusion Criteria:

          1. Contraindication to receiving MMF (CellCept) or increasing CellCept dose.

          2. Clinically suspected acute rejection (AR) or BPAR within 3 months prior to the
             baseline visit.

          3. Proteinuria ≥ 1 g/24 hours

          4. Treatment with AZA (Imuran), EC-MPS (Myfortic) or SRL (Rapamune) and patient or
             physician decision not to discontinue these agents and switch to MMF (CellCept) at the
             time of randomization.

          5. MDRD (4-variable) eGFR < 15 mL/min/1.73 m2

          6. Patients who currently exceed thresholds for plasma glucose, cholesterol or blood
             pressure. Patients may be re-considered 1 month after the treatment is in place and no
             further therapeutic changes are anticipated.

          7. Patients who require changes to their blood pressure, blood sugar or blood lipid
             management between the Screening Visit and Day 0. Patients may be re-considered 1
             month after the adjusted treatment is in place and no further therapeutic changes are
             anticipated.

          8. Pregnancy, lactation or (for women of childbearing potential) inability or decision
             not to use a reliable method of contraception for the entire study duration.

          9. Active infection requiring treatment.

         10. Treatment with unlicensed investigational drugs, devices or other prohibited
             medications - see Section 4.4.1

         11. Participation in any other interventional clinical trial during the previous 4 weeks
             or during this trial.

         12. History of malignancy, other than non-melanoma skin cancer that has been totally
             excised and has not recurred for >2 years.

         13. History of psychological illness or condition that could interfere with the patient's
             ability to understand or comply with the study requirements.

         14. Presence of other significant diseases or issues which, in the opinion of the
             sponsor-investigator, may:

               -  Put the patient at risk as a result of study participation

               -  Influence the study result

               -  Affect the patient's ability to participate in the study

               -  Require a change in immunosuppression medication used or a dose change within the
                  next 6 months (unstable renal function, gout that may require treatment with
                  prednisone, etc)

               -  Reduce life expectancy. Examples include but are not limited to history of
                  noncompliance and transportation issues that could affect a participant's ability
                  to successfully complete the study requirements. Inability or refusal to provide
                  blood samples, end-stage disease of organs such as lung, liver or heart.

         15. Exclusion of patients who are hypersensitive to CellCept (mycophenolate mofetil),
             mycophenolic acid or any component of the drug).