Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft
Conditions
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.
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Achieving at Least Two Mycophenolic Acid (MPA) Dose Steps Higher and Reducing Tacrolimus Dose at the End of the Study | at 12 months from baseline |
| 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 | at 12 months from baseline |
| Participants With Reduction in Tacrolimus or Tacrolimus Extended Release Levels at the End of the Study (Final Visit) Compared to Baseline Dose. | at 12 months from baseline |
| Mean Mycophenolic Acid (MPA) Doses at the End of the Study (Final Visit) Compared to Baseline Dose. | at 12 months from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score. | 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) | 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 |
| 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 | at 12 months from baseline | 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) |
| 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 | at 12 months from baseline | 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) |
| 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 | at 12 months from baseline | 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) |
| 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 | at 12 months from baseline | 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) |
| 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 | at 12 months from baseline | 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) |
| 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 | at 12 months from baseline | 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) |
| 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 | at 12 months from baseline | 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 |
| Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl) | 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) | — |
| 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 | at 12 months from baseline | 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 |
| 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 | at 12 months from baseline | 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 |
| 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 | at 12 months from baseline | 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 |
| 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 | at 12 months from baseline | 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 |
| Duration of Exposure to the Study Medicinal Product, Mycophenolate Sodium Descriptive Statistics. Safety Population Per Treatment Group | at 12 months from baseline | Exposure to study drug (MPS). Data presented only for safety population on the study treatment arm (not applicable for MMF arm) |
| Dose of the Study Medicinal Product Mycophenolate Sodium (MPS) | at 12 months from baseline | Safety population per visit and per treatment group |
| Dose of the Study Medicinal Product Mycophenolate Mofetil (MMF) | at 12 months from baseline | Safety population per visit and per treatment group (missings not included) |
| 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 | at 12 months from baseline | 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 |
| Glomerular Filtration Rate (GFR) Using Abbreviated MDRD | 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) | 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 |
| Gastrointestinal Symptom Rating Scale (GSRS) Item Score | 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) | 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) |
| Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | 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) | 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) |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 43 |
| 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). | 38 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 6 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Mycophenolate Mofetil (MMF) | Mycophenolate Sodium (MPS) | Total |
|---|---|---|---|
| Age, Continuous | 48.50 years STANDARD_DEVIATION 12.86 | 52.88 years STANDARD_DEVIATION 9.99 | 50.83 years STANDARD_DEVIATION 11.56 |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Caucasian | 36 participants | 39 participants | 75 participants |
| Race/Ethnicity, Customized Other | 2 participants | 4 participants | 6 participants |
| Sex: Female, Male Female | 13 Participants | 15 Participants | 28 Participants |
| Sex: Female, Male Male | 25 Participants | 28 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 46 | 10 / 40 |
| serious Total, serious adverse events | 2 / 46 | 4 / 40 |
Outcome results
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
Population: Per protocol (PP) population included all subjects from the ITT population who received medication throughout the study and did not have major protocol deviations and who participated in the study for a minimum of 210 days +/- 15 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mycophenolate Sodium (MPS) | Mean Mycophenolic Acid (MPA) Doses at the End of the Study (Final Visit) Compared to Baseline Dose. | 1173.10 mg/day | Standard Deviation 278.94 |
| Mycophenolate Mofetil (MMF) | Mean Mycophenolic Acid (MPA) Doses at the End of the Study (Final Visit) Compared to Baseline Dose. | 1195.20 mg/day | Standard Deviation 297.95 |
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mycophenolate Sodium (MPS) | Number of Participants Achieving at Least Two Mycophenolic Acid (MPA) Dose Steps Higher and Reducing Tacrolimus Dose at the End of the Study | # of participants with ≥2 MPA dose steps higher | 0 number of participants |
| Mycophenolate Sodium (MPS) | Number of Participants Achieving at Least Two Mycophenolic Acid (MPA) Dose Steps Higher and Reducing Tacrolimus Dose at the End of the Study | # of participants with <2 MPA dose steps higher | 43 number of participants |
| Mycophenolate Mofetil (MMF) | Number of Participants Achieving at Least Two Mycophenolic Acid (MPA) Dose Steps Higher and Reducing Tacrolimus Dose at the End of the Study | # of participants with ≥2 MPA dose steps higher | 0 number of participants |
| Mycophenolate Mofetil (MMF) | Number of Participants Achieving at Least Two Mycophenolic Acid (MPA) Dose Steps Higher and Reducing Tacrolimus Dose at the End of the Study | # of participants with <2 MPA dose steps higher | 38 number of participants |
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mycophenolate Sodium (MPS) | 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 | # of participants with ≥ 1 MPA dose steps higher | 37 study participants |
| Mycophenolate Sodium (MPS) | 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 | # of participants with < 1 MPA dose steps higher | 6 study participants |
| Mycophenolate Mofetil (MMF) | 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 | # of participants with ≥ 1 MPA dose steps higher | 30 study participants |
| Mycophenolate Mofetil (MMF) | 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 | # of participants with < 1 MPA dose steps higher | 8 study participants |
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mycophenolate Sodium (MPS) | Participants With Reduction in Tacrolimus or Tacrolimus Extended Release Levels at the End of the Study (Final Visit) Compared to Baseline Dose. | Reduction in tacrolimus or tacrolimus ER levels | 27 Participants |
| Mycophenolate Sodium (MPS) | Participants With Reduction in Tacrolimus or Tacrolimus Extended Release Levels at the End of the Study (Final Visit) Compared to Baseline Dose. | No reduction in tacrolimus or tacrolimus ER levels | 16 Participants |
| Mycophenolate Mofetil (MMF) | Participants With Reduction in Tacrolimus or Tacrolimus Extended Release Levels at the End of the Study (Final Visit) Compared to Baseline Dose. | Reduction in tacrolimus or tacrolimus ER levels | 18 Participants |
| Mycophenolate Mofetil (MMF) | Participants With Reduction in Tacrolimus or Tacrolimus Extended Release Levels at the End of the Study (Final Visit) Compared to Baseline Dose. | No reduction in tacrolimus or tacrolimus ER levels | 20 Participants |
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
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | 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 | SNP present in the MRP2 gene (n=9, 14) | 1.78 scores on a scale | Standard Deviation 6.65 |
| Mycophenolate Sodium (MPS) | 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 | No SNP present in the MRP2 gene (n=12, 14) | -2.00 scores on a scale | Standard Deviation 6.94 |
| Mycophenolate Mofetil (MMF) | 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 | SNP present in the MRP2 gene (n=9, 14) | 0.79 scores on a scale | Standard Deviation 5.91 |
| Mycophenolate Mofetil (MMF) | 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 | No SNP present in the MRP2 gene (n=12, 14) | 1.93 scores on a scale | Standard Deviation 5.36 |
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
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | 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 | SNP present in the UGT1A9 gene (n=3, 3) | 1.67 scores on a scale | Standard Deviation 10.5 |
| Mycophenolate Sodium (MPS) | 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 | No SNP present in the UGT1A9 gene (n=18, 25) | -0.72 scores on a scale | Standard Deviation 6.52 |
| Mycophenolate Mofetil (MMF) | 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 | SNP present in the UGT1A9 gene (n=3, 3) | 0.00 scores on a scale | Standard Deviation 1.73 |
| Mycophenolate Mofetil (MMF) | 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 | No SNP present in the UGT1A9 gene (n=18, 25) | 1.52 scores on a scale | Standard Deviation 5.86 |
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
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | 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 | SNP present in the MRP2 gene (n=9, 14) | 5.67 scores on a scale | Standard Deviation 11.48 |
| Mycophenolate Sodium (MPS) | 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 | No SNP present in the MRP2 gene (n=14, 14) | 0.07 scores on a scale | Standard Deviation 7.79 |
| Mycophenolate Mofetil (MMF) | 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 | SNP present in the MRP2 gene (n=9, 14) | 3.71 scores on a scale | Standard Deviation 6.23 |
| Mycophenolate Mofetil (MMF) | 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 | No SNP present in the MRP2 gene (n=14, 14) | 1.71 scores on a scale | Standard Deviation 12.57 |
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
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | 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 | SNP present in the UGT1A9 gene (n=4, 3) | 6.25 scores on a scale | Standard Deviation 12.39 |
| Mycophenolate Sodium (MPS) | 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 | No SNP present in the UGT1A9 gene (n=19, 25) | 1.42 scores on a scale | Standard Deviation 9.06 |
| Mycophenolate Mofetil (MMF) | 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 | SNP present in the UGT1A9 gene (n=4, 3) | 0.67 scores on a scale | Standard Deviation 2.31 |
| Mycophenolate Mofetil (MMF) | 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 | No SNP present in the UGT1A9 gene (n=19, 25) | 2.96 scores on a scale | Standard Deviation 10.33 |
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
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | 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 | SNP present in the MRP2 gene (n=9, 14) | 3.67 scores on a scale | Standard Deviation 10.17 |
| Mycophenolate Sodium (MPS) | 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 | No SNP present in the MRP2 gene (n=14, 14) | 0.93 scores on a scale | Standard Deviation 9.88 |
| Mycophenolate Mofetil (MMF) | 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 | SNP present in the MRP2 gene (n=9, 14) | 1.92 scores on a scale | Standard Deviation 9.4 |
| Mycophenolate Mofetil (MMF) | 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 | No SNP present in the MRP2 gene (n=14, 14) | -1.57 scores on a scale | Standard Deviation 8.94 |
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
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missing not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | 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 | SNP present in the UGT1A9 gene (n=3,3) | 8.00 scores on a scale | Standard Deviation 13.86 |
| Mycophenolate Sodium (MPS) | 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 | No SNP present in the UGT1A9 gene (n=20, 23) | 1.10 scores on a scale | Standard Deviation 9.26 |
| Mycophenolate Mofetil (MMF) | 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 | SNP present in the UGT1A9 gene (n=3,3) | 4.00 scores on a scale | Standard Deviation 4 |
| Mycophenolate Mofetil (MMF) | 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 | No SNP present in the UGT1A9 gene (n=20, 23) | -0.48 scores on a scale | Standard Deviation 9.55 |
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)
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl) | Visit 2 (n=41,34) | 81.59 ml/min | Standard Deviation 26.6 |
| Mycophenolate Sodium (MPS) | Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl) | Baseline (n=42,38) | 83.01 ml/min | Standard Deviation 26.51 |
| Mycophenolate Sodium (MPS) | Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl) | Visit 1 (n=41,37) | 81.55 ml/min | Standard Deviation 26.88 |
| Mycophenolate Sodium (MPS) | Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl) | Visit 3 (n=37,35) | 84.91 ml/min | Standard Deviation 24.2 |
| Mycophenolate Sodium (MPS) | Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl) | Visit 4 (n=39,33) | 86.58 ml/min | Standard Deviation 26.82 |
| Mycophenolate Sodium (MPS) | Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl) | Visit 5 (n=36,33) | 88.08 ml/min | Standard Deviation 26.4 |
| Mycophenolate Mofetil (MMF) | Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl) | Visit 4 (n=39,33) | 81.83 ml/min | Standard Deviation 24.89 |
| Mycophenolate Mofetil (MMF) | Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl) | Visit 3 (n=37,35) | 80.25 ml/min | Standard Deviation 23.25 |
| Mycophenolate Mofetil (MMF) | Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl) | Baseline (n=42,38) | 83.44 ml/min | Standard Deviation 29.1 |
| Mycophenolate Mofetil (MMF) | Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl) | Visit 5 (n=36,33) | 88.28 ml/min | Standard Deviation 29.17 |
| Mycophenolate Mofetil (MMF) | Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl) | Visit 1 (n=41,37) | 83.04 ml/min | Standard Deviation 27.06 |
| Mycophenolate Mofetil (MMF) | Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl) | Visit 2 (n=41,34) | 82.88 ml/min | Standard Deviation 24.7 |
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
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | 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 | SNP present in the MRP2 gene (n=9,16) | -0.89 scores on a scale | Standard Deviation 3.79 |
| Mycophenolate Sodium (MPS) | 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 | No SNP present in the MRP2 gene (n=13, 15) | -1.69 scores on a scale | Standard Deviation 4.33 |
| Mycophenolate Mofetil (MMF) | 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 | SNP present in the MRP2 gene (n=9,16) | 0.56 scores on a scale | Standard Deviation 4.65 |
| Mycophenolate Mofetil (MMF) | 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 | No SNP present in the MRP2 gene (n=13, 15) | -1.40 scores on a scale | Standard Deviation 5.49 |
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
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | 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 | SNP present in the UGT1A9 gene (n=4, 3) | -5.50 scores on a scale | Standard Deviation 6.45 |
| Mycophenolate Sodium (MPS) | 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 | No SNP present in the MRP2 gene (n=18, 28) | -0.44 scores on a scale | Standard Deviation 2.81 |
| Mycophenolate Mofetil (MMF) | 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 | SNP present in the UGT1A9 gene (n=4, 3) | 0.33 scores on a scale | Standard Deviation 0.58 |
| Mycophenolate Mofetil (MMF) | 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 | No SNP present in the MRP2 gene (n=18, 28) | -0.46 scores on a scale | Standard Deviation 5.35 |
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
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | 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 | SNP present in the MRP2 gene (n=9,15) | -2.67 scores on a scale | Standard Deviation 7.78 |
| Mycophenolate Sodium (MPS) | 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 | No SNP present in the MRP2 gene (n=14, 15) | -2.64 scores on a scale | Standard Deviation 7.04 |
| Mycophenolate Mofetil (MMF) | 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 | SNP present in the MRP2 gene (n=9,15) | -1.73 scores on a scale | Standard Deviation 5.4 |
| Mycophenolate Mofetil (MMF) | 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 | No SNP present in the MRP2 gene (n=14, 15) | -3.33 scores on a scale | Standard Deviation 10.29 |
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
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | 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 | SNP present in the UGT1A9 gene (n=4, 3) | -5.75 scores on a scale | Standard Deviation 7.41 |
| Mycophenolate Sodium (MPS) | 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 | No SNP present in the UGT1A9 gene (n=19, 27) | -2.00 scores on a scale | Standard Deviation 7.14 |
| Mycophenolate Mofetil (MMF) | 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 | SNP present in the UGT1A9 gene (n=4, 3) | -1.67 scores on a scale | Standard Deviation 2.52 |
| Mycophenolate Mofetil (MMF) | 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 | No SNP present in the UGT1A9 gene (n=19, 27) | -2.63 scores on a scale | Standard Deviation 8.54 |
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
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missing not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | 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 | SNP present in the MRP2 gene (n=9,14) | -1.11 scores on a scale | Standard Deviation 6.86 |
| Mycophenolate Sodium (MPS) | 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 | No SNP present in the MRP2 gene (n=14, 15) | -0.36 scores on a scale | Standard Deviation 5.02 |
| Mycophenolate Mofetil (MMF) | 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 | SNP present in the MRP2 gene (n=9,14) | -0.50 scores on a scale | Standard Deviation 7.85 |
| Mycophenolate Mofetil (MMF) | 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 | No SNP present in the MRP2 gene (n=14, 15) | -1.40 scores on a scale | Standard Deviation 6.17 |
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
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
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | 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 | SNP present in the UGT1A9 gene (n=3, 3) | -1.33 scores on a scale | Standard Deviation 8.39 |
| Mycophenolate Sodium (MPS) | 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 | No SNP present in the UGT1A9 gene (n=20, 26) | -0.55 scores on a scale | Standard Deviation 5.45 |
| Mycophenolate Mofetil (MMF) | 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 | SNP present in the UGT1A9 gene (n=3, 3) | -3.67 scores on a scale | Standard Deviation 6.35 |
| Mycophenolate Mofetil (MMF) | 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 | No SNP present in the UGT1A9 gene (n=20, 26) | -0.65 scores on a scale | Standard Deviation 7.03 |
Secondary
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
Population: The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | Dose of the Study Medicinal Product Mycophenolate Mofetil (MMF) | Baseline visit (n=40) | 806.25 mg | Standard Deviation 222.8 |
| Mycophenolate Sodium (MPS) | Dose of the Study Medicinal Product Mycophenolate Mofetil (MMF) | Visit 1 (n=38) | 1250.00 mg | Standard Deviation 278.75 |
| Mycophenolate Sodium (MPS) | Dose of the Study Medicinal Product Mycophenolate Mofetil (MMF) | Visit 2 (n=35) | 1578.57 mg | Standard Deviation 382.39 |
| Mycophenolate Sodium (MPS) | Dose of the Study Medicinal Product Mycophenolate Mofetil (MMF) | Visit 3 (n=35) | 1757.14 mg | Standard Deviation 381.01 |
Secondary
Dose of the Study Medicinal Product Mycophenolate Sodium (MPS)
Safety population per visit and per treatment group
Time frame: at 12 months from baseline
Population: The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | Dose of the Study Medicinal Product Mycophenolate Sodium (MPS) | Baseline visit (n=46) | 579.13 mg | Standard Deviation 165.03 |
| Mycophenolate Sodium (MPS) | Dose of the Study Medicinal Product Mycophenolate Sodium (MPS) | Visit 1 (n=43) | 856.28 mg | Standard Deviation 181.65 |
| Mycophenolate Sodium (MPS) | Dose of the Study Medicinal Product Mycophenolate Sodium (MPS) | Visit 2 (n=41) | 1080.00 mg | Standard Deviation 238.12 |
| Mycophenolate Sodium (MPS) | Dose of the Study Medicinal Product Mycophenolate Sodium (MPS) | Visit 3 (n=40) | 1228.50 mg | Standard Deviation 263.81 |
Secondary
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
Population: The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mycophenolate Sodium (MPS) | Duration of Exposure to the Study Medicinal Product, Mycophenolate Sodium Descriptive Statistics. Safety Population Per Treatment Group | 201.91 days | Standard Deviation 49 |
Secondary
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)
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Hard stool (n=42,37) | 1.52 scores on a scale | Standard Deviation 1.04 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Incomplete bowel emptying (n=39,35) | 1.67 scores on a scale | Standard Deviation 0.96 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Rumbling in stomach (n=43,37) | 1.93 scores on a scale | Standard Deviation 1.12 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Upper Abdomen Pain (n=41,34) | 1.66 scores on a scale | Standard Deviation 1.26 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Fecal incontinence (n=42,37) | 1.67 scores on a scale | Standard Deviation 1.18 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Heartburn (n=41,34) | 1.59 scores on a scale | Standard Deviation 1.24 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Hunger pains (n=36,34) | 1.94 scores on a scale | Standard Deviation 1.49 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Acid reflux (n=41,34) | 1.46 scores on a scale | Standard Deviation 1.12 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline, Incomplete bowel emptying (n=42,37) | 1.57 scores on a scale | Standard Deviation 0.99 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Hunger pains (n=41,34) | 2.00 scores on a scale | Standard Deviation 1.6 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Upper Abdomen Pain (n=40,34) | 1.43 scores on a scale | Standard Deviation 0.75 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Nausea (n=41,34) | 1.37 scores on a scale | Standard Deviation 0.8 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Bloated (n=43,37) | 1.77 scores on a scale | Standard Deviation 1.27 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Rumbling in stomach (n=41,34) | 2.02 scores on a scale | Standard Deviation 1.09 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Heartburn (n=40,35) | 1.43 scores on a scale | Standard Deviation 1.06 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Bloated (n=41,34) | 1.68 scores on a scale | Standard Deviation 1.04 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Burping (n=41,34) | 2.02 scores on a scale | Standard Deviation 1.41 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline Visit, Heartburn (n=42,37) | 1.29 scores on a scale | Standard Deviation 0.92 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Passing gas/Flatus (n=41,34) | 2.46 scores on a scale | Standard Deviation 1.21 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Acid reflux (n=40,35) | 1.30 scores on a scale | Standard Deviation 0.76 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Constipation (n=41,34) | 1.41 scores on a scale | Standard Deviation 0.74 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Burping (n=43,37) | 1.91 scores on a scale | Standard Deviation 1.21 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Hunger pains (n=39,34) | 2.33 scores on a scale | Standard Deviation 1.77 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Loose stool (n=41,34) | 2.00 scores on a scale | Standard Deviation 1.5 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Diorrhoea ((n=41,34) | 1.59 scores on a scale | Standard Deviation 1.26 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Hard stool (n=40,34) | 1.53 scores on a scale | Standard Deviation 0.88 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Nausea (n=39,34) | 1.23 scores on a scale | Standard Deviation 0.67 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Fecal incontinence (n=40,34) | 1.68 scores on a scale | Standard Deviation 1.29 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Passing gas/Flatus (n=43,37) | 2.19 scores on a scale | Standard Deviation 1.38 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Incomplete bowel emptying(n=40,34) | 1.68 scores on a scale | Standard Deviation 0.92 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Rumbling in stomach (n=39,34) | 1.85 scores on a scale | Standard Deviation 1.06 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Upper Abdomen Pain (n=36,34) | 1.72 scores on a scale | Standard Deviation 1.19 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Acid reflux (n=42,37) | 1.40 scores on a scale | Standard Deviation 0.77 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Heartburn (n=36,34) | 1.47 scores on a scale | Standard Deviation 0.94 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Bloated (n=40,35) | 1.73 scores on a scale | Standard Deviation 1.09 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Acid reflux (n=36,34) | 1.25 scores on a scale | Standard Deviation 0.6 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Burping (n=40,35) | 1.80 scores on a scale | Standard Deviation 1.11 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Constipation (n=42,37) | 1.71 scores on a scale | Standard Deviation 1.15 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Nausea (n=36,34) | 1.28 scores on a scale | Standard Deviation 0.7 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Passing gas/Flatus (n=40,35) | 2.35 scores on a scale | Standard Deviation 1.42 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Rumbling in stomach (n=36,34) | 2.03 scores on a scale | Standard Deviation 1.13 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Hunger pains (n=43,37) | 2.30 scores on a scale | Standard Deviation 1.52 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Bloated (n=36,34) | 1.69 scores on a scale | Standard Deviation 1.12 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Constipation (n=40,33) | 1.58 scores on a scale | Standard Deviation 1.13 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Burping (n=36,34) | 1.75 scores on a scale | Standard Deviation 1.18 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Diorrhoea (n=42,37) | 1.45 scores on a scale | Standard Deviation 1.09 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Passing gas/Flatus (n=36,34) | 2.33 scores on a scale | Standard Deviation 1.31 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Diorrhoea (n=40,33) | 1.38 scores on a scale | Standard Deviation 0.84 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Constipation (n=36,34) | 1.47 scores on a scale | Standard Deviation 0.91 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Nausea (n=43,37) | 1.30 scores on a scale | Standard Deviation 0.99 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Diorrhoea (n=36,34) | 1.42 scores on a scale | Standard Deviation 1.02 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Loose stool (n=40,32) | 1.73 scores on a scale | Standard Deviation 1.04 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Loose stool (n=36,34) | 1.83 scores on a scale | Standard Deviation 1.23 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Loose stool (n=42,37) | 1.69 scores on a scale | Standard Deviation 1.16 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Hard stool (n=36,34) | 1.36 scores on a scale | Standard Deviation 0.72 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Hard stool (n=39,35) | 1.51 scores on a scale | Standard Deviation 1.12 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Fecal incontinence (n=36,34) | 1.86 scores on a scale | Standard Deviation 1.33 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline Visit, Upper Abdomen Pain(n=42,37) | 1.64 scores on a scale | Standard Deviation 1.08 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Incomplete bowel emptying (n=36,34) | 1.69 scores on a scale | Standard Deviation 1.04 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Fecal incontinence (n=39,34) | 1.69 scores on a scale | Standard Deviation 1.3 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Fecal incontinence (n=39,34) | 2.12 scores on a scale | Standard Deviation 1.51 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline, Incomplete bowel emptying (n=42,37) | 1.97 scores on a scale | Standard Deviation 1.36 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Bloated (n=40,35) | 2.09 scores on a scale | Standard Deviation 1.48 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Bloated (n=41,34) | 2.15 scores on a scale | Standard Deviation 1.58 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Acid reflux (n=42,37) | 1.41 scores on a scale | Standard Deviation 0.98 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline Visit, Upper Abdomen Pain(n=42,37) | 1.70 scores on a scale | Standard Deviation 1.02 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline Visit, Heartburn (n=42,37) | 1.54 scores on a scale | Standard Deviation 1.41 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Nausea (n=43,37) | 1.35 scores on a scale | Standard Deviation 0.95 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Rumbling in stomach (n=43,37) | 1.92 scores on a scale | Standard Deviation 1.36 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Bloated (n=43,37) | 2.27 scores on a scale | Standard Deviation 1.71 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Burping (n=43,37) | 2.00 scores on a scale | Standard Deviation 1.39 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Passing gas/Flatus (n=43,37) | 2.38 scores on a scale | Standard Deviation 1.48 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Constipation (n=42,37) | 1.62 scores on a scale | Standard Deviation 1.36 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Diorrhoea (n=42,37) | 1.51 scores on a scale | Standard Deviation 1.17 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Loose stool (n=42,37) | 1.84 scores on a scale | Standard Deviation 1.38 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Hard stool (n=42,37) | 1.65 scores on a scale | Standard Deviation 1.16 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Fecal incontinence (n=42,37) | 2.03 scores on a scale | Standard Deviation 1.69 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Upper Abdomen Pain (n=40,34) | 1.74 scores on a scale | Standard Deviation 1.16 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Heartburn (n=40,35) | 1.37 scores on a scale | Standard Deviation 0.73 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Acid reflux (n=40,35) | 1.57 scores on a scale | Standard Deviation 0.95 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Hunger pains (n=39,34) | 2.15 scores on a scale | Standard Deviation 1.33 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Nausea (n=39,34) | 1.29 scores on a scale | Standard Deviation 0.76 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Rumbling in stomach (n=39,34) | 1.85 scores on a scale | Standard Deviation 1.16 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Burping (n=40,35) | 2.00 scores on a scale | Standard Deviation 1.55 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Passing gas/Flatus (n=40,35) | 2.34 scores on a scale | Standard Deviation 1.49 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Constipation (n=40,33) | 1.52 scores on a scale | Standard Deviation 0.97 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Diorrhoea (n=40,33) | 1.82 scores on a scale | Standard Deviation 1.42 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Loose stool (n=40,32) | 1.91 scores on a scale | Standard Deviation 1.2 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Hard stool (n=39,35) | 1.46 scores on a scale | Standard Deviation 0.82 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Baseline visit, Hunger pains (n=43,37) | 1.92 scores on a scale | Standard Deviation 1.21 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 2, Incomplete bowel emptying (n=39,35) | 1.69 scores on a scale | Standard Deviation 1.13 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Upper Abdomen Pain (n=41,34) | 2.00 scores on a scale | Standard Deviation 1.3 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Heartburn (n=41,34) | 1.74 scores on a scale | Standard Deviation 1.19 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Acid reflux (n=41,34) | 1.56 scores on a scale | Standard Deviation 0.99 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Hunger pains (n=41,34) | 2.26 scores on a scale | Standard Deviation 1.29 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Nausea (n=41,34) | 1.59 scores on a scale | Standard Deviation 1.18 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Rumbling in stomach (n=41,34) | 1.91 scores on a scale | Standard Deviation 1.22 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Burping (n=41,34) | 2.21 scores on a scale | Standard Deviation 1.47 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Passing gas/Flatus (n=41,34) | 2.44 scores on a scale | Standard Deviation 1.48 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Constipation (n=41,34) | 1.85 scores on a scale | Standard Deviation 1.42 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Diorrhoea ((n=41,34) | 1.88 scores on a scale | Standard Deviation 1.09 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Loose stool (n=41,34) | 1.94 scores on a scale | Standard Deviation 1.13 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Hard stool (n=40,34) | 1.85 scores on a scale | Standard Deviation 1.26 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Fecal incontinence (n=40,34) | 2.12 scores on a scale | Standard Deviation 1.43 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 4, Incomplete bowel emptying(n=40,34) | 1.88 scores on a scale | Standard Deviation 1.25 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Upper Abdomen Pain (n=36,34) | 1.85 scores on a scale | Standard Deviation 1.28 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Heartburn (n=36,34) | 1.56 scores on a scale | Standard Deviation 1.08 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Acid reflux (n=36,34) | 1.71 scores on a scale | Standard Deviation 1.14 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Hunger pains (n=36,34) | 2.12 scores on a scale | Standard Deviation 2.03 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Nausea (n=36,34) | 1.38 scores on a scale | Standard Deviation 0.92 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Rumbling in stomach (n=36,34) | 2.00 scores on a scale | Standard Deviation 1.41 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Bloated (n=36,34) | 2.12 scores on a scale | Standard Deviation 1.53 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Burping (n=36,34) | 2.00 scores on a scale | Standard Deviation 1.5 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Passing gas/Flatus (n=36,34) | 2.41 scores on a scale | Standard Deviation 1.6 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Constipation (n=36,34) | 1.68 scores on a scale | Standard Deviation 1.01 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Diorrhoea (n=36,34) | 1.71 scores on a scale | Standard Deviation 0.91 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Loose stool (n=36,34) | 1.74 scores on a scale | Standard Deviation 0.96 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Hard stool (n=36,34) | 1.79 scores on a scale | Standard Deviation 1.12 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Fecal incontinence (n=36,34) | 2.32 scores on a scale | Standard Deviation 1.7 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Item Score | Visit 5, Incomplete bowel emptying (n=36,34) | 1.85 scores on a scale | Standard Deviation 1.18 |
Secondary
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)
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 2, Abdominal pain (n=39,33) | 1.67 scores on a scale | Standard Deviation 0.71 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 4, Abdominal pain (n=41,34) | 1.67 scores on a scale | Standard Deviation 0.83 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Baseline visit, Constipation (n=41,37) | 1.59 scores on a scale | Standard Deviation 0.91 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 4, Indigestion (n=41,34) | 2.05 scores on a scale | Standard Deviation 0.97 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 2, Indigestion (n=39,34) | 1.92 scores on a scale | Standard Deviation 0.87 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 4, Diorrhoea (n=40,34) | 1.72 scores on a scale | Standard Deviation 1.23 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Baseline visit, Diorrhoea (n=41,37) | 1.58 scores on a scale | Standard Deviation 0.93 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 4, Constipation(n=40,34) | 1.54 scores on a scale | Standard Deviation 0.68 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 2, Diorrhoea (n=39,32) | 1.59 scores on a scale | Standard Deviation 0.94 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 5, Reflux (n=36,34) | 1.36 scores on a scale | Standard Deviation 0.69 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 2, Reflux (n=40,35) | 1.36 scores on a scale | Standard Deviation 0.81 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 5, Abdominal pain (n=36,34) | 1.65 scores on a scale | Standard Deviation 0.66 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 2, Constpation (n=39,33) | 1.59 scores on a scale | Standard Deviation 0.88 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Baseline visit, Indigestion (n=43,37) | 1.95 scores on a scale | Standard Deviation 0.89 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 5, Diorrhoea (n=36,34) | 1.70 scores on a scale | Standard Deviation 1.02 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 4, Reflux (n=41,34) | 1.52 scores on a scale | Standard Deviation 1.15 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 5, Constipation (n=36,34) | 1.51 scores on a scale | Standard Deviation 0.65 |
| Mycophenolate Sodium (MPS) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 5, Indigestion (n=36,34) | 1.95 scores on a scale | Standard Deviation 0.95 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 5, Constipation (n=36,34) | 1.77 scores on a scale | Standard Deviation 0.89 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Baseline visit, Indigestion (n=43,37) | 2.14 scores on a scale | Standard Deviation 1.29 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Baseline visit, Diorrhoea (n=41,37) | 1.79 scores on a scale | Standard Deviation 1.26 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Baseline visit, Constipation (n=41,37) | 1.75 scores on a scale | Standard Deviation 1.12 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 2, Reflux (n=40,35) | 1.47 scores on a scale | Standard Deviation 0.74 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 2, Abdominal pain (n=39,33) | 1.71 scores on a scale | Standard Deviation 0.88 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 2, Indigestion (n=39,34) | 1.96 scores on a scale | Standard Deviation 1.08 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 2, Diorrhoea (n=39,32) | 1.94 scores on a scale | Standard Deviation 1.19 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 2, Constpation (n=39,33) | 1.56 scores on a scale | Standard Deviation 0.86 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 4, Reflux (n=41,34) | 1.65 scores on a scale | Standard Deviation 1.04 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 4, Abdominal pain (n=41,34) | 1.95 scores on a scale | Standard Deviation 1.12 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 4, Indigestion (n=41,34) | 2.18 scores on a scale | Standard Deviation 1.27 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 4, Diorrhoea (n=40,34) | 1.98 scores on a scale | Standard Deviation 1.08 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 4, Constipation(n=40,34) | 1.86 scores on a scale | Standard Deviation 1.12 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 5, Reflux (n=36,34) | 1.63 scores on a scale | Standard Deviation 1.06 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 5, Abdominal pain (n=36,34) | 1.78 scores on a scale | Standard Deviation 1.03 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 5, Indigestion (n=36,34) | 2.13 scores on a scale | Standard Deviation 1.28 |
| Mycophenolate Mofetil (MMF) | Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score | Visit 5, Diorrhoea (n=36,34) | 1.92 scores on a scale | Standard Deviation 1.04 |
Secondary
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)
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | Glomerular Filtration Rate (GFR) Using Abbreviated MDRD | Visit 1 (n=42, 38; missings not included) | 62.68 mL/min/1.73m^2 | Standard Deviation 17.68 |
| Mycophenolate Sodium (MPS) | Glomerular Filtration Rate (GFR) Using Abbreviated MDRD | Visit 3 (n=40, 35; missings not included) | 67.74 mL/min/1.73m^2 | Standard Deviation 18.28 |
| Mycophenolate Sodium (MPS) | Glomerular Filtration Rate (GFR) Using Abbreviated MDRD | Baseline visit (n=43, 38) | 64.83 mL/min/1.73m^2 | Standard Deviation 17.59 |
| Mycophenolate Sodium (MPS) | Glomerular Filtration Rate (GFR) Using Abbreviated MDRD | Visit 4 (n=42, 36; missings not included) | 67.21 mL/min/1.73m^2 | Standard Deviation 20.19 |
| Mycophenolate Sodium (MPS) | Glomerular Filtration Rate (GFR) Using Abbreviated MDRD | Visit 5 (n=38, 35; missings not included) | 70.24 mL/min/1.73m^2 | Standard Deviation 19.23 |
| Mycophenolate Sodium (MPS) | Glomerular Filtration Rate (GFR) Using Abbreviated MDRD | Visit 2 (n=41, 35; missings not included) | 62.71 mL/min/1.73m^2 | Standard Deviation 17.02 |
| Mycophenolate Mofetil (MMF) | Glomerular Filtration Rate (GFR) Using Abbreviated MDRD | Visit 5 (n=38, 35; missings not included) | 68.11 mL/min/1.73m^2 | Standard Deviation 19.84 |
| Mycophenolate Mofetil (MMF) | Glomerular Filtration Rate (GFR) Using Abbreviated MDRD | Baseline visit (n=43, 38) | 61.08 mL/min/1.73m^2 | Standard Deviation 13.94 |
| Mycophenolate Mofetil (MMF) | Glomerular Filtration Rate (GFR) Using Abbreviated MDRD | Visit 1 (n=42, 38; missings not included) | 59.78 mL/min/1.73m^2 | Standard Deviation 12.32 |
| Mycophenolate Mofetil (MMF) | Glomerular Filtration Rate (GFR) Using Abbreviated MDRD | Visit 2 (n=41, 35; missings not included) | 60.84 mL/min/1.73m^2 | Standard Deviation 13.35 |
| Mycophenolate Mofetil (MMF) | Glomerular Filtration Rate (GFR) Using Abbreviated MDRD | Visit 3 (n=40, 35; missings not included) | 59.32 mL/min/1.73m^2 | Standard Deviation 13.71 |
| Mycophenolate Mofetil (MMF) | Glomerular Filtration Rate (GFR) Using Abbreviated MDRD | Visit 4 (n=42, 36; missings not included) | 61.20 mL/min/1.73m^2 | Standard Deviation 15.78 |
Secondary
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)
Population: Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mycophenolate Sodium (MPS) | Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score. | Visit 2 (n=38,32) | 78.79 scores on a scale | Standard Deviation 6.2 |
| Mycophenolate Sodium (MPS) | Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score. | Baseline visit (n=41,37) | 79.20 scores on a scale | Standard Deviation 6.86 |
| Mycophenolate Sodium (MPS) | Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score. | Visit 4 (n=40,34) | 77.88 scores on a scale | Standard Deviation 6.64 |
| Mycophenolate Sodium (MPS) | Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score. | Visit 5, Diorrhoea (n=36,34) | 78.53 scores on a scale | Standard Deviation 5.06 |
| Mycophenolate Mofetil (MMF) | Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score. | Visit 2 (n=38,32) | 76.34 scores on a scale | Standard Deviation 10.12 |
| Mycophenolate Mofetil (MMF) | Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score. | Visit 5, Diorrhoea (n=36,34) | 76.41 scores on a scale | Standard Deviation 8.36 |
| Mycophenolate Mofetil (MMF) | Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score. | Visit 4 (n=40,34) | 74.53 scores on a scale | Standard Deviation 10.24 |
| Mycophenolate Mofetil (MMF) | Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score. | Baseline visit (n=41,37) | 76.00 scores on a scale | Standard Deviation 9.55 |