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CompletedNCT01056822MAXIMIZAUpdated Dec 3, 2014Results posted

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.

A Phase 4 interventional study of 1 and 2 in Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft, sponsored by Novartis Pharmaceuticals. Completed at 19 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-12-03.

Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
89
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft
03

In context

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
89 participants (actual)

Study arms

  • Active comparator
    1

    Mycophenolate mofetil

    Drug: 1

  • Experimental
    2

    Miycophenolate sodium

    Drug: 2

Interventions

  • Drug1

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

  • Drug2

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

06

What researchers measure

Primary outcomes

  1. 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. 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. 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. Mean Mycophenolic Acid (MPA) Doses at the End of the Study (Final Visit) Compared to Baseline Dose.

    Time frame: at 12 months from baseline

Secondary outcomes

  1. 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)

  2. Glomerular Filtration Rate (GFR) Using Abbreviated MDRD

    Calculated GFR (MDRD formula): GFR \[mL/min/1.73m2\] = 186.3\*(C-1.154)\*(A-0.203)\*G\*R where C is the serum concentration of creatinine \[mg/dL\], A is age \[years\], G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1

    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)

  3. Gastrointestinal Symptom Rating Scale (GSRS) Item Score

    The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

    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)

  4. Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score

    The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

    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)

  5. Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score.

    The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

    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. 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

    Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

    Time frame: at 12 months from baseline

  7. 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

    Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

    Time frame: at 12 months from baseline

  8. 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

    Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

    Time frame: at 12 months from baseline

  9. 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

    Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

    Time frame: at 12 months from baseline

  10. 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

    Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

    Time frame: at 12 months from baseline

  11. 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

    Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

    Time frame: at 12 months from baseline

  12. 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

    Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

    Time frame: at 12 months from baseline

  13. 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

    Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

    Time frame: at 12 months from baseline

  14. 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

    Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

    Time frame: at 12 months from baseline

  15. 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

    Sub-study primary endpoint. SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

    Time frame: at 12 months from baseline

  16. 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

    Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

    Time frame: at 12 months from baseline

  17. 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

    Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

    Time frame: at 12 months from baseline

  18. Duration of Exposure to the Study Medicinal Product, Mycophenolate Sodium Descriptive Statistics. Safety Population Per Treatment Group

    Exposure to study drug (MPS). Data presented only for safety population on the study treatment arm (not applicable for MMF arm)

    Time frame: at 12 months from baseline

  19. Dose of the Study Medicinal Product Mycophenolate Sodium (MPS)

    Safety population per visit and per treatment group

    Time frame: at 12 months from baseline

  20. Dose of the Study Medicinal Product Mycophenolate Mofetil (MMF)

    Safety population per visit and per treatment group (missings not included)

    Time frame: at 12 months from baseline

07

Results

Posted Dec 3, 2014

Participant flow

Participant flow — Overall Study
MilestoneMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
Started4742
Intention-to-treat (itt) population: yes4338
Intention-to-treat (itt) population: no44
Per-protocol (pp) population: yes2925
Per-protocol (pp) population: no1817
Safety (saf) population: yes4640
Safety (saf) population: no12
Completed3935
Not completed87
Withdrew: Adverse event01
Withdrew: Protocol violation65
Withdrew: Withdrawal by subject11
Withdrew: Lost to follow-up10

Outcome measures

PrimaryNumber 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
Reported as:
Number · number of participants
Number of Participants Achieving at Least Two Mycophenolic Acid (MPA) Dose Steps Higher and Reducing Tacrolimus Dose at the End of the Study
number of participantsMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
# of participants with ≥2 MPA dose steps higher00
# of participants with <2 MPA dose steps higher4338
PrimaryNumber 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
Reported as:
Number · study participants
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
study participantsMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
# of participants with ≥ 1 MPA dose steps higher3730
# of participants with < 1 MPA dose steps higher68
PrimaryParticipants 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
Reported as:
Number · Participants
Participants With Reduction in Tacrolimus or Tacrolimus Extended Release Levels at the End of the Study (Final Visit) Compared to Baseline Dose.
ParticipantsMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
Reduction in tacrolimus or tacrolimus ER levels2718
No reduction in tacrolimus or tacrolimus ER levels1620
PrimaryMean Mycophenolic Acid (MPA) Doses at the End of the Study (Final Visit) Compared to Baseline Dose.
Time frame:
at 12 months from baseline
Reported as:
Mean · mg/day
Mean Mycophenolic Acid (MPA) Doses at the End of the Study (Final Visit) Compared to Baseline Dose.
mg/dayMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
Mean Mycophenolic Acid (MPA) Doses at the End of the Study (Final Visit) Compared to Baseline Dose.1173.10 ± 278.941195.20 ± 297.95
SecondaryChange 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)
Reported as:
Mean · ml/min
Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl)
ml/minMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
Baseline (n=42,38)83.01 ± 26.5183.44 ± 29.10
Visit 1 (n=41,37)81.55 ± 26.8883.04 ± 27.06
Visit 2 (n=41,34)81.59 ± 26.6082.88 ± 24.70
Visit 3 (n=37,35)84.91 ± 24.2080.25 ± 23.25
Visit 4 (n=39,33)86.58 ± 26.8281.83 ± 24.89
Visit 5 (n=36,33)88.08 ± 26.4088.28 ± 29.17
SecondaryGlomerular Filtration Rate (GFR) Using Abbreviated MDRD

Calculated GFR (MDRD formula): GFR \[mL/min/1.73m2\] = 186.3\*(C-1.154)\*(A-0.203)\*G\*R where C is the serum concentration of creatinine \[mg/dL\], A is age \[years\], G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1

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)
Reported as:
Mean · mL/min/1.73m^2
Glomerular Filtration Rate (GFR) Using Abbreviated MDRD
mL/min/1.73m^2Mycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
Baseline visit (n=43, 38)64.83 ± 17.5961.08 ± 13.94
Visit 1 (n=42, 38; missings not included)62.68 ± 17.6859.78 ± 12.32
Visit 2 (n=41, 35; missings not included)62.71 ± 17.0260.84 ± 13.35
Visit 3 (n=40, 35; missings not included)67.74 ± 18.2859.32 ± 13.71
Visit 4 (n=42, 36; missings not included)67.21 ± 20.1961.20 ± 15.78
Visit 5 (n=38, 35; missings not included)70.24 ± 19.2368.11 ± 19.84
SecondaryGastrointestinal Symptom Rating Scale (GSRS) Item Score

The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

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)
Reported as:
Mean · scores on a scale
Gastrointestinal Symptom Rating Scale (GSRS) Item Score
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
Baseline Visit, Upper Abdomen Pain(n=42,37)1.64 ± 1.081.70 ± 1.02
Baseline Visit, Heartburn (n=42,37)1.29 ± 0.921.54 ± 1.41
Baseline visit, Acid reflux (n=42,37)1.40 ± 0.771.41 ± 0.98
Baseline visit, Hunger pains (n=43,37)2.30 ± 1.521.92 ± 1.21
Baseline visit, Nausea (n=43,37)1.30 ± 0.991.35 ± 0.95
Baseline visit, Rumbling in stomach (n=43,37)1.93 ± 1.121.92 ± 1.36
Baseline visit, Bloated (n=43,37)1.77 ± 1.272.27 ± 1.71
Baseline visit, Burping (n=43,37)1.91 ± 1.212.00 ± 1.39
Baseline visit, Passing gas/Flatus (n=43,37)2.19 ± 1.382.38 ± 1.48
Baseline visit, Constipation (n=42,37)1.71 ± 1.151.62 ± 1.36
Baseline visit, Diorrhoea (n=42,37)1.45 ± 1.091.51 ± 1.17
Baseline visit, Loose stool (n=42,37)1.69 ± 1.161.84 ± 1.38
Baseline visit, Hard stool (n=42,37)1.52 ± 1.041.65 ± 1.16
Baseline visit, Fecal incontinence (n=42,37)1.67 ± 1.182.03 ± 1.69
Baseline, Incomplete bowel emptying (n=42,37)1.57 ± 0.991.97 ± 1.36
Visit 2, Upper Abdomen Pain (n=40,34)1.43 ± 0.751.74 ± 1.16
Visit 2, Heartburn (n=40,35)1.43 ± 1.061.37 ± 0.73
Visit 2, Acid reflux (n=40,35)1.30 ± 0.761.57 ± 0.95
Visit 2, Hunger pains (n=39,34)2.33 ± 1.772.15 ± 1.33
Visit 2, Nausea (n=39,34)1.23 ± 0.671.29 ± 0.76
Visit 2, Rumbling in stomach (n=39,34)1.85 ± 1.061.85 ± 1.16
Visit 2, Bloated (n=40,35)1.73 ± 1.092.09 ± 1.48
Visit 2, Burping (n=40,35)1.80 ± 1.112.00 ± 1.55
Visit 2, Passing gas/Flatus (n=40,35)2.35 ± 1.422.34 ± 1.49
Visit 2, Constipation (n=40,33)1.58 ± 1.131.52 ± 0.97
Visit 2, Diorrhoea (n=40,33)1.38 ± 0.841.82 ± 1.42
Visit 2, Loose stool (n=40,32)1.73 ± 1.041.91 ± 1.20
Visit 2, Hard stool (n=39,35)1.51 ± 1.121.46 ± 0.82
Visit 2, Fecal incontinence (n=39,34)1.69 ± 1.302.12 ± 1.51
Visit 2, Incomplete bowel emptying (n=39,35)1.67 ± 0.961.69 ± 1.13
Visit 4, Upper Abdomen Pain (n=41,34)1.66 ± 1.262.00 ± 1.30
Visit 4, Heartburn (n=41,34)1.59 ± 1.241.74 ± 1.19
Visit 4, Acid reflux (n=41,34)1.46 ± 1.121.56 ± 0.99
Visit 4, Hunger pains (n=41,34)2.00 ± 1.602.26 ± 1.29
Visit 4, Nausea (n=41,34)1.37 ± 0.801.59 ± 1.18
Visit 4, Rumbling in stomach (n=41,34)2.02 ± 1.091.91 ± 1.22
Visit 4, Bloated (n=41,34)1.68 ± 1.042.15 ± 1.58
Visit 4, Burping (n=41,34)2.02 ± 1.412.21 ± 1.47
Visit 4, Passing gas/Flatus (n=41,34)2.46 ± 1.212.44 ± 1.48
Visit 4, Constipation (n=41,34)1.41 ± 0.741.85 ± 1.42
Visit 4, Diorrhoea ((n=41,34)1.59 ± 1.261.88 ± 1.09
Visit 4, Loose stool (n=41,34)2.00 ± 1.501.94 ± 1.13
Visit 4, Hard stool (n=40,34)1.53 ± 0.881.85 ± 1.26
Visit 4, Fecal incontinence (n=40,34)1.68 ± 1.292.12 ± 1.43
Visit 4, Incomplete bowel emptying(n=40,34)1.68 ± 0.921.88 ± 1.25
Visit 5, Upper Abdomen Pain (n=36,34)1.72 ± 1.191.85 ± 1.28
Visit 5, Heartburn (n=36,34)1.47 ± 0.941.56 ± 1.08
Visit 5, Acid reflux (n=36,34)1.25 ± 0.601.71 ± 1.14
Visit 5, Hunger pains (n=36,34)1.94 ± 1.492.12 ± 2.03
Visit 5, Nausea (n=36,34)1.28 ± 0.701.38 ± 0.92
Visit 5, Rumbling in stomach (n=36,34)2.03 ± 1.132.00 ± 1.41
Visit 5, Bloated (n=36,34)1.69 ± 1.122.12 ± 1.53
Visit 5, Burping (n=36,34)1.75 ± 1.182.00 ± 1.50
Visit 5, Passing gas/Flatus (n=36,34)2.33 ± 1.312.41 ± 1.60
Visit 5, Constipation (n=36,34)1.47 ± 0.911.68 ± 1.01
Visit 5, Diorrhoea (n=36,34)1.42 ± 1.021.71 ± 0.91
Visit 5, Loose stool (n=36,34)1.83 ± 1.231.74 ± 0.96
Visit 5, Hard stool (n=36,34)1.36 ± 0.721.79 ± 1.12
Visit 5, Fecal incontinence (n=36,34)1.86 ± 1.332.32 ± 1.70
Visit 5, Incomplete bowel emptying (n=36,34)1.69 ± 1.041.85 ± 1.18
SecondaryGastrointestinal Symptom Rating Scale (GSRS) Subscale Score

The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

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)
Reported as:
Mean · scores on a scale
Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
Baseline visit, Indigestion (n=43,37)1.95 ± 0.892.14 ± 1.29
Baseline visit, Diorrhoea (n=41,37)1.58 ± 0.931.79 ± 1.26
Baseline visit, Constipation (n=41,37)1.59 ± 0.911.75 ± 1.12
Visit 2, Reflux (n=40,35)1.36 ± 0.811.47 ± 0.74
Visit 2, Abdominal pain (n=39,33)1.67 ± 0.711.71 ± 0.88
Visit 2, Indigestion (n=39,34)1.92 ± 0.871.96 ± 1.08
Visit 2, Diorrhoea (n=39,32)1.59 ± 0.941.94 ± 1.19
Visit 2, Constpation (n=39,33)1.59 ± 0.881.56 ± 0.86
Visit 4, Reflux (n=41,34)1.52 ± 1.151.65 ± 1.04
Visit 4, Abdominal pain (n=41,34)1.67 ± 0.831.95 ± 1.12
Visit 4, Indigestion (n=41,34)2.05 ± 0.972.18 ± 1.27
Visit 4, Diorrhoea (n=40,34)1.72 ± 1.231.98 ± 1.08
Visit 4, Constipation(n=40,34)1.54 ± 0.681.86 ± 1.12
Visit 5, Reflux (n=36,34)1.36 ± 0.691.63 ± 1.06
Visit 5, Abdominal pain (n=36,34)1.65 ± 0.661.78 ± 1.03
Visit 5, Indigestion (n=36,34)1.95 ± 0.952.13 ± 1.28
Visit 5, Diorrhoea (n=36,34)1.70 ± 1.021.92 ± 1.04
Visit 5, Constipation (n=36,34)1.51 ± 0.651.77 ± 0.89
SecondaryHealth-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score.

The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

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)
Reported as:
Mean · scores on a scale
Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score.
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
Baseline visit (n=41,37)79.20 ± 6.8676.00 ± 9.55
Visit 2 (n=38,32)78.79 ± 6.2076.34 ± 10.12
Visit 4 (n=40,34)77.88 ± 6.6474.53 ± 10.24
Visit 5, Diorrhoea (n=36,34)78.53 ± 5.0676.41 ± 8.36
SecondaryChange 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

Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

Time frame:
at 12 months from baseline
Reported as:
Mean · scores on a scale
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
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
SNP present in the UGT1A9 gene (n=3, 3)1.67 ± 10.500.00 ± 1.73
No SNP present in the UGT1A9 gene (n=18, 25)-0.72 ± 6.521.52 ± 5.86
SecondaryChange 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

Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

Time frame:
at 12 months from baseline
Reported as:
Mean · scores on a scale
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
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
SNP present in the UGT1A9 gene (n=4, 3)6.25 ± 12.390.67 ± 2.31
No SNP present in the UGT1A9 gene (n=19, 25)1.42 ± 9.062.96 ± 10.33
SecondaryChange 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

Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

Time frame:
at 12 months from baseline
Reported as:
Mean · scores on a scale
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
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
SNP present in the UGT1A9 gene (n=3,3)8.00 ± 13.864.00 ± 4.00
No SNP present in the UGT1A9 gene (n=20, 23)1.10 ± 9.26-0.48 ± 9.55
SecondaryChange 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

Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

Time frame:
at 12 months from baseline
Reported as:
Mean · scores on a scale
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
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
SNP present in the MRP2 gene (n=9, 14)1.78 ± 6.650.79 ± 5.91
No SNP present in the MRP2 gene (n=12, 14)-2.00 ± 6.941.93 ± 5.36
SecondaryChange 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

Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

Time frame:
at 12 months from baseline
Reported as:
Mean · scores on a scale
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
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
SNP present in the MRP2 gene (n=9, 14)5.67 ± 11.483.71 ± 6.23
No SNP present in the MRP2 gene (n=14, 14)0.07 ± 7.791.71 ± 12.57
SecondaryChange 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

Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)

Time frame:
at 12 months from baseline
Reported as:
Mean · scores on a scale
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
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
SNP present in the MRP2 gene (n=9, 14)3.67 ± 10.171.92 ± 9.40
No SNP present in the MRP2 gene (n=14, 14)0.93 ± 9.88-1.57 ± 8.94
SecondaryChange 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

Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

Time frame:
at 12 months from baseline
Reported as:
Mean · scores on a scale
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
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
SNP present in the UGT1A9 gene (n=4, 3)-5.50 ± 6.450.33 ± 0.58
No SNP present in the MRP2 gene (n=18, 28)-0.44 ± 2.81-0.46 ± 5.35
SecondaryChange 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

Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

Time frame:
at 12 months from baseline
Reported as:
Mean · scores on a scale
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
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
SNP present in the UGT1A9 gene (n=4, 3)-5.75 ± 7.41-1.67 ± 2.52
No SNP present in the UGT1A9 gene (n=19, 27)-2.00 ± 7.14-2.63 ± 8.54
SecondaryChange 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

Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

Time frame:
at 12 months from baseline
Reported as:
Mean · scores on a scale
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
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
SNP present in the UGT1A9 gene (n=3, 3)-1.33 ± 8.39-3.67 ± 6.35
No SNP present in the UGT1A9 gene (n=20, 26)-0.55 ± 5.45-0.65 ± 7.03
SecondaryChange 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

Sub-study primary endpoint. SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

Time frame:
at 12 months from baseline
Reported as:
Mean · scores on a scale
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
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
SNP present in the MRP2 gene (n=9,16)-0.89 ± 3.790.56 ± 4.65
No SNP present in the MRP2 gene (n=13, 15)-1.69 ± 4.33-1.40 ± 5.49
SecondaryChange 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

Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

Time frame:
at 12 months from baseline
Reported as:
Mean · scores on a scale
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
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
SNP present in the MRP2 gene (n=9,15)-2.67 ± 7.78-1.73 ± 5.40
No SNP present in the MRP2 gene (n=14, 15)-2.64 ± 7.04-3.33 ± 10.29
SecondaryChange 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

Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient

Time frame:
at 12 months from baseline
Reported as:
Mean · scores on a scale
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
scores on a scaleMycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)
SNP present in the MRP2 gene (n=9,14)-1.11 ± 6.86-0.50 ± 7.85
No SNP present in the MRP2 gene (n=14, 15)-0.36 ± 5.02-1.40 ± 6.17
SecondaryDuration of Exposure to the Study Medicinal Product, Mycophenolate Sodium Descriptive Statistics. Safety Population Per Treatment Group

Exposure to study drug (MPS). Data presented only for safety population on the study treatment arm (not applicable for MMF arm)

Time frame:
at 12 months from baseline
Reported as:
Mean · days
Duration of Exposure to the Study Medicinal Product, Mycophenolate Sodium Descriptive Statistics. Safety Population Per Treatment Group
daysMycophenolate Sodium (MPS)
Duration of Exposure to the Study Medicinal Product, Mycophenolate Sodium Descriptive Statistics. Safety Population Per Treatment Group201.91 ± 49.00
SecondaryDose of the Study Medicinal Product Mycophenolate Sodium (MPS)

Safety population per visit and per treatment group

Time frame:
at 12 months from baseline
Reported as:
Mean · mg
Dose of the Study Medicinal Product Mycophenolate Sodium (MPS)
mgMycophenolate Sodium (MPS)
Baseline visit (n=46)579.13 ± 165.03
Visit 1 (n=43)856.28 ± 181.65
Visit 2 (n=41)1080.00 ± 238.12
Visit 3 (n=40)1228.50 ± 263.81
SecondaryDose of the Study Medicinal Product Mycophenolate Mofetil (MMF)

Safety population per visit and per treatment group (missings not included)

Time frame:
at 12 months from baseline
Reported as:
Mean · mg
Dose of the Study Medicinal Product Mycophenolate Mofetil (MMF)
mgMycophenolate Mofetil (MMF)
Baseline visit (n=40)806.25 ± 222.80
Visit 1 (n=38)1250.00 ± 278.75
Visit 2 (n=35)1578.57 ± 382.39
Visit 3 (n=35)1757.14 ± 381.01

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Micofenolato Sodium—2/46 (4.3%)13/46 (28.3%)
Micofenolato Mofetilo—4/40 (10%)10/40 (25%)
Most frequent serious events
Most frequent serious events
EventMicofenolato SodiumMicofenolato Mofetilo
Acute coronary syndromeCardiac disorders0/461/40
Graft infectionInfections and infestations0/461/40
Human polyomavirus infectionInfections and infestations0/461/40
Urinary tract infectionInfections and infestations0/461/40
Renal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/461/40
DiarrhoeaGastrointestinal disorders1/460/40
Escherichia urinary tract infectionInfections and infestations1/460/40
Most frequent other events
Most frequent other events
EventMicofenolato SodiumMicofenolato Mofetilo
Urinary tract infectionInfections and infestations5/461/40
DiarrhoeaGastrointestinal disorders3/463/40
DyspepsiaGastrointestinal disorders3/460/40
Abdominal discomfortGastrointestinal disorders1/462/40
FatigueGeneral disorders1/462/40
Blood creatinine increasedInvestigations1/462/40
HeadacheNervous system disorders0/462/40

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)Mycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)Total
Mean52.88 ± 9.9948.50 ± 12.8650.83 ± 11.56
Sex: Female, Male
Sex: Female, Male(Participants)Mycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)Total
Female151328
Male282553
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Mycophenolate Sodium (MPS)Mycophenolate Mofetil (MMF)Total
Caucasian393675
Black000
Asian000
Other426
08

Study locations

19 sites
  • Novartis Investigative Site
    Granada, Andalucia 18014, Spain
  • Novartis Investigative Site
    Oviedo, Asturias 33006, Spain
  • Novartis Investigative Site
    Santander, Cantabria 39008, Spain
  • Novartis Investigative Site
    Toledo, Castilla la Mancha 45004, Spain
  • Novartis Investigative Site
    Valladolid, Castilla y Leon 47011, Spain
  • Novartis Investigative Site
    Barcelona, Catalunya 08025, Spain
  • Novartis Investigative Site
    Barcelona, Cataluña 08003, Spain
  • Novartis Investigative Site
    Barcelona, Cataluña 08036, Spain
  • Novartis Investigative Site
    Alicante, Comunidad Valenciana 03010, Spain
  • Novartis Investigative Site
    Valencia, Comunidad Valenciana 46017, Spain
  • Novartis Investigative Site
    La Coruna, Galicia 15006, Spain
  • Novartis Investigative Site
    Palma de Mallorca, Islas Baleares 07014, Spain
  • Novartis Investigative Site
    La Laguna, Las Palmas de Gran Canaria 38320, Spain
  • Novartis Investigative Site
    Pamplona, Navarra 31080, Spain
  • Novartis Investigative Site
    Barakaldo, Pais Vasco 48903, Spain
  • Novartis Investigative Site
    Madrid, 28040, Spain
  • Novartis Investigative Site
    Madrid, 28041, Spain
  • Novartis Investigative Site
    Madrid, Spain
  • Novartis Investigative Site
    Zaragoza, 50009, Spain
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01056822
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Jan 26, 2010
Start date
May 2010
Primary completion
Apr 2013
Completion
Apr 2013
Results posted
Dec 3, 2014
Last update
Dec 3, 2014

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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