Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate Sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate Mofetil (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study.
Condition: Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft
Intervention: 1; 2
Intervention description: Continue with same dose of MMF as patient was taking before randomisation; Increase MPS by 180mg every 12h based on investigator's judgement up to a maximum of 720 mg of MPS every 12 hours
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate
      sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate mofetil (MMF) Leading to a
      Dose Reduction of Tacrolimus. Maximiza Study.
    

Eligibility criteria:

        Inclusion criteria

          1. Renal transplant recipients ≥ 1 year and ≤ 5 years prior1 to inclusion in the study.

          2. Patients who were receiving an immunosuppressive regimen including MMF ≤1000 mg/day
             and ≥ 250 mg/day 4 and Prograf®1 or Advagraf®6 (levels ≥7 ng/ml).

          3. Patients who had been receiving the current maintenance immunosuppressive regimen with
             stable doses of MMF for at least the past 3 months.2

          4. Patients included must have had Prograf® or Advagraf® levels ≥ 7ng/ml4 for at least
             one month prior to inclusion in the trial.2

          5. Patients with low immunological risk, in the investigator's opinion.

          6. Patients with an estimated glomerular filtration rate based on the MDRD formula of >
             30 ml/min x 1.73 m2.1

          7. Patients over 18 years of age.1

          8. Patients who were able to understand the study information and give written informed
             consent.

          9. Patients who were able to meet all study requirements, including completing
             questionnaires and attending study visits.

        Exclusion criteria

          1. Patients with GI symptoms known or assumed not to be caused by mycophenolic acid (MPA)
             treatment (e.g. oral bisphosphonate-induced infectious diarrhoea).

          2. Patients with chronic inflammatory bowel disease.

          3. Diabetic patients.

          4. Acute rejection < 1 month prior to inclusion in the study.

          5. Patients with leukopenia (< 3500 cells/mm3) or thrombocytopenia (< 100,000 cells/mm3).

          6. Women of childbearing potential who were planning to become pregnant, were pregnant
             and/or breastfeeding, or who did not wish to use effective contraception [hormonal
             contraceptives (implantation, patches, oral) and double-barrier methods (any double
             combination of: IUD, male or female condoms with spermicidal gel, diaphragm,
             contraceptive sponge, cervical cap)].

          7. Presence of psychiatric illness (such as schizophrenia, major depression) that, in the
             investigator's opinion, could interfere with study requirements.

          8. Patients who were undergoing surgery for an acute condition or who were hospitalised.

          9. Any other medical condition that, in the investigator's opinion based on blood counts
             or chart review, could interfere with completion of the study, including but not
             limited to visual problems or cognitive impairment.

         10. Patients who were receiving or had received any investigational medicinal product
             during the 30 days prior to inclusion in the study.