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.

NCT ID: NCT01056822

Last Updated: 2014-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-04-30

Brief 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.

Conditions

Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Mycophenolate mofetil

Group Type: ACTIVE_COMPARATOR

1

Intervention Type: DRUG

Continue with same dose of MMF as patient was taking before randomisation

2

Miycophenolate sodium

Group Type: EXPERIMENTAL

2

Intervention Type: DRUG

Increase MPS by 180mg every 12h based on investigator's judgement up to a maximum of 720 mg of MPS every 12 hours

Interventions

1

Continue with same dose of MMF as patient was taking before randomisation

Intervention Type: DRUG

2

Increase MPS by 180mg every 12h based on investigator's judgement up to a maximum of 720 mg of MPS every 12 hours

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Granada, Andalusia, Spain

Novartis Investigative Site

Palma de Mallorca, Balearic Islands, Spain

Novartis Investigative Site

Barakaldo, Basque Country, Spain

Novartis Investigative Site

Santander, Cantabria, Spain

Novartis Investigative Site

Valladolid, Castille and León, Spain

Novartis Investigative Site

Toledo, Castille-La Mancha, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

A Coruña, Galicia, Spain

Novartis Investigative Site

San Cristóbal de La Laguna, Las Palmas de Gran Canaria, Spain

Novartis Investigative Site

Madrid, Madrid, Spain

Novartis Investigative Site

Madrid, Madrid, Spain

Novartis Investigative Site

Madrid, Madrid, Spain

Novartis Investigative Site

Pamplona, Navarre, Spain

Novartis Investigative Site

Oviedo, Principality of Asturias, Spain

Novartis Investigative Site

Alicante, Valencia, Spain

Novartis Investigative Site

Valencia, Valencia, Spain

Novartis Investigative Site

Zaragoza, Zaragoza, Spain

Countries

Spain

Other Identifiers

2009-014562-26

Identifier Type: -

Identifier Source: secondary_id

CERL080AES08

Identifier Type: -

Identifier Source: org_study_id