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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01056822
First received: January 25, 2010
Last updated: December 2, 2014
Last verified: December 2014
Results First Received: April 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft
Interventions: Drug: 1
Drug: 2

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Mycophenolate Sodium (MPS) Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
Mycophenolate Mofetil (MMF) Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).

Participant Flow:   Overall Study
    Mycophenolate Sodium (MPS)     Mycophenolate Mofetil (MMF)  
STARTED     47     42  
Intention-to-treat (ITT) Population: YES     43     38  
Intention-to-treat (ITT) Population: NO     4     4  
Per-protocol (PP) Population: YES     29     25  
Per-protocol (PP) Population: NO     18     17  
Safety (SAF) Population: YES     46     40  
Safety (SAF) Population: NO     1     2  
COMPLETED     39     35  
NOT COMPLETED     8     7  
Adverse Event                 0                 1  
Protocol Violation                 6                 5  
Withdrawal by Subject                 1                 1  
Lost to Follow-up                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intention-to-treat (ITT) population consisted of all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product and have at least one baseline visit and one post-baseline visit (containing data to allow the primary endpoint to be calculated) Standard Deviation

Reporting Groups
  Description
Mycophenolate Sodium (MPS) Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
Mycophenolate Mofetil (MMF) Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
Total Total of all reporting groups

Baseline Measures
    Mycophenolate Sodium (MPS)     Mycophenolate Mofetil (MMF)     Total  
Number of Participants  
[units: participants]
  43     38     81  
Age  
[units: years]
Mean (Standard Deviation)
  52.88  (9.99)     48.50  (12.86)     50.83  (11.56)  
Gender  
[units: participants]
     
Female     15     13     28  
Male     28     25     53  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     39     36     75  
Black     0     0     0  
Asian     0     0     0  
Other     4     2     6  



  Outcome Measures
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1.  Primary:   Number of Participants Achieving at Least Two Mycophenolic Acid (MPA) Dose Steps Higher and Reducing Tacrolimus Dose at the End of the Study   [ Time Frame: at 12 months from baseline ]

2.  Primary:   Number of Participants That Achieved One Dose Step Higher With Mycophenolic Acid (MPA) or Mycophenolate Mofetil (MMF), According to the Treatment Group Assigned at the End of the Study (Final Visit) Compared to Baseline Dose   [ Time Frame: at 12 months from baseline ]

3.  Primary:   Participants With Reduction in Tacrolimus or Tacrolimus Extended Release Levels at the End of the Study (Final Visit) Compared to Baseline Dose.   [ Time Frame: at 12 months from baseline ]

4.  Primary:   Mean Mycophenolic Acid (MPA) Doses at the End of the Study (Final Visit) Compared to Baseline Dose.   [ Time Frame: at 12 months from baseline ]

5.  Secondary:   Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl)   [ Time Frame: Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15) ]

6.  Secondary:   Glomerular Filtration Rate (GFR) Using Abbreviated MDRD   [ Time Frame: Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15) ]

7.  Secondary:   Gastrointestinal Symptom Rating Scale (GSRS) Item Score   [ Time Frame: Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15) ]

8.  Secondary:   Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score   [ Time Frame: Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15) ]

9.  Secondary:   Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score.   [ Time Frame: Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15) ]

10.  Secondary:   Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population   [ Time Frame: at 12 months from baseline ]

11.  Secondary:   Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population   [ Time Frame: at 12 months from baseline ]

12.  Secondary:   Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population   [ Time Frame: at 12 months from baseline ]

13.  Secondary:   Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population   [ Time Frame: at 12 months from baseline ]

14.  Secondary:   Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population   [ Time Frame: at 12 months from baseline ]

15.  Secondary:   Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population   [ Time Frame: at 12 months from baseline ]

16.  Secondary:   Change in SIGIT-QoL Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population   [ Time Frame: at 12 months from baseline ]

17.  Secondary:   Change in SIGIT-QoL Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population   [ Time Frame: at 12 months from baseline ]

18.  Secondary:   Change in SIGIT-QoL Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population   [ Time Frame: at 12 months from baseline ]

19.  Secondary:   Change in SIGIT-QoL Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population   [ Time Frame: at 12 months from baseline ]

20.  Secondary:   Change in SIGIT-QoL Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population   [ Time Frame: at 12 months from baseline ]

21.  Secondary:   Change in SIGIT-QoL Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population   [ Time Frame: at 12 months from baseline ]

22.  Secondary:   Duration of Exposure to the Study Medicinal Product, Mycophenolate Sodium Descriptive Statistics. Safety Population Per Treatment Group   [ Time Frame: at 12 months from baseline ]

23.  Secondary:   Dose of the Study Medicinal Product Mycophenolate Sodium (MPS)   [ Time Frame: at 12 months from baseline ]

24.  Secondary:   Dose of the Study Medicinal Product Mycophenolate Mofetil (MMF)   [ Time Frame: at 12 months from baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Novartis
Organization: Pharmaceuticals
phone: +1 (862) 778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01056822     History of Changes
Other Study ID Numbers: CERL080AES08
2009-014562-26
Study First Received: January 25, 2010
Results First Received: April 10, 2014
Last Updated: December 2, 2014
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios