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. (MAXIMIZA)

Novartis

Status and phase: Completed; Phase 4

Conditions: Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft

Treatments: Drug: 2; Drug: 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01056822

CERL080AES08

2009-014562-26

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

1

Active Comparator group

Description:

Mycophenolate mofetil

Treatment:

Drug: 1

2

Experimental group

Description:

Miycophenolate sodium

Treatment:

Drug: 2