Trial Outcomes & Findings for Myfortic or CellCept Gastrointestinal Effects in African American Kidney Recipients (NCT NCT00522548)
NCT ID: NCT00522548
Last Updated: 2018-01-23
Results Overview
At 24 weeks, we assessed the number of patients at this timepoint who required permanent dose decrease or discontinuation of either enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent formulation manufactured by Sandoz related to gastrointestinal toxicity.
TERMINATED
PHASE4
37 participants
6 months
2018-01-23
Participant Flow
Recruitment occured at the Hospital of the University of Pennsylvania March 2007-June 2010. Living donor kidney recipients were approached in clinic at pre-transplant visit (within 30 days or less of transplant. Recipients of deceased donor kidney transplants were approached inpatient at transplant or 2 days thereafter.
Patients were not randomized until they were transplanted.
Participant milestones
| Measure |
Myfortic Comparator Group
Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) 180 mg tablets administered as 720mg (4 tablets) orally twice daily (adjusted for side effects as needed) in addition to immunosuppressants: Thymoglobulin (Rabbit antithymocyte globulin), Prograf (tacrolimus) or its generic equivalanet and corticosteroids.
|
CellCept Comparator Group
Patients in this group will receive CellCept (mycophenolate mofetil) 250mg capsules administered as 1000mg (4 capsules) orally twice daily (adjusted for side effects as needed) in addition to immunosuppressants: Thymoglobulin (rabbit anti-thymocyte globulin) Prograf (tacrolimus) or its generic equivalent and corticosteroids.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
Consented to Pharmacokinetic Study
|
11
|
10
|
|
Overall Study
Completed 0/2 PK Visits
|
3
|
4
|
|
Overall Study
Completed 1/2 PK Visits
|
1
|
1
|
|
Overall Study
Completed 2/2 PK Visits
|
7
|
5
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Myfortic Comparator Group
Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) 180 mg tablets administered as 720mg (4 tablets) orally twice daily (adjusted for side effects as needed) in addition to immunosuppressants: Thymoglobulin (Rabbit antithymocyte globulin), Prograf (tacrolimus) or its generic equivalanet and corticosteroids.
|
CellCept Comparator Group
Patients in this group will receive CellCept (mycophenolate mofetil) 250mg capsules administered as 1000mg (4 capsules) orally twice daily (adjusted for side effects as needed) in addition to immunosuppressants: Thymoglobulin (rabbit anti-thymocyte globulin) Prograf (tacrolimus) or its generic equivalent and corticosteroids.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Myfortic or CellCept Gastrointestinal Effects in African American Kidney Recipients
Baseline characteristics by cohort
| Measure |
Myfortic Comparator Group
n=18 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=19 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Based on the number of patients who were participating in the trial at that timepoint and had not withdrawn at 24 weeks
At 24 weeks, we assessed the number of patients at this timepoint who required permanent dose decrease or discontinuation of either enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent formulation manufactured by Sandoz related to gastrointestinal toxicity.
Outcome measures
| Measure |
Myfortic Comparator Group
n=17 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=14 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
Gastrointestinal Toxicity Due to Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz
|
9 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Based on number of patients participating in study at 6 months
If patients were not on any medications from a medication class known as H-2 antagonists, they were started on ranitidine 150 mg orally twice daily after transplant (with dose adjusted for renal function). Patients were excluded if they were on proton pump inhibitor at time of study screening, however some patients required addition of proton pump inhibitor post-study enrollment. If a patient had upper gastrointestinal side effects such as acid reflux unreleived on ranitidine therapy or nausea, they were switched to a proton pump inhibitor.
Outcome measures
| Measure |
Myfortic Comparator Group
n=17 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=14 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
The Incidence of the Requirement of Full Dose Proton Pump Inhibitors in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Based on number of patients participating in the study at 6 months
The incidence of intolerance was defined as transient dose reduction or transient discontinuation of enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent manufactured by Sandoz meaning doses could subsequently be resumed or increased back to original starting dose, once intolerance resolved.
Outcome measures
| Measure |
Myfortic Comparator Group
n=17 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=14 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
The Incidence of Intolerance (Defined as Transient Dose Reduction or Transient Discontinuation of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: baseline (pre-transplant to two days after transplant) and at 6 months after transplant.Population: Patients who withdrew from the study before 24 weeks were excluded from this analysis.
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, indigestion, constipation, abdominal pain, and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 after transplant.
Outcome measures
| Measure |
Myfortic Comparator Group
n=17 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=14 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
Gastrointestinal Symptom Rating Scale (GSRS) Score Changes From Baseline to 24 Weeks After Transplant in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
Worsening of GSRS Score pre-transplant-wk 24
|
4 Participants
|
4 Participants
|
|
Gastrointestinal Symptom Rating Scale (GSRS) Score Changes From Baseline to 24 Weeks After Transplant in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
No Worsening of GSRS Score pre-transplant-wk 24
|
13 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Any patient with mean GSRS subscale score \>1 from dimensions: abdominal pain, indigestion, or reflux were considered to have upper GI symptoms.
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, constipation, abdominal pain, indigestion and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 post-transplant.
Outcome measures
| Measure |
Myfortic Comparator Group
n=17 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=14 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
The Incidence of the Occurrence of Upper Gastrointestinal Symptoms Per GSRS Scale Ratings in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz
Number of Participants with Upper GI symptoms
|
8 Participants
|
11 Participants
|
|
The Incidence of the Occurrence of Upper Gastrointestinal Symptoms Per GSRS Scale Ratings in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz
Number of Participants without Upper GI symptoms
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Any patient with a mean GSRS subscale score \> 1 on dimensions constipation or diarrhea were considered to have lower GI symptoms.
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item self-administered questionnaire to assess symptoms associated with common gastrointestinal (GI) disorders, and has been validated in renal transplant recipients. It uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one and the patient grades symptoms based on the past 7 days. A score of ≥ 2 indicates the presence of GI symptoms. Higher values indicate more unfavorable conditions. The questionairre is divided into 5 sub-scales: diarrhea, constipation, abdominal pain, indigestion and reflux and a mean score is calculated for each dimension. The lowest mean score possible for each dimension is 1 and the highest is 7. Patients completed a GSRS survey at baseline (pre-transplant to two days after transplant), and at weeks 1,4,12 and 24 post-transplant. Patients who withdrew from the study only had data included up to the point of withdraw. No values were carried forward.
Outcome measures
| Measure |
Myfortic Comparator Group
n=17 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=14 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
The Incidence of the Occurrence of Lower Gastrointestinal Symptoms Per GSRS Scale Ratings in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
Number of Participants with Lower GI symptoms
|
8 Participants
|
9 Participants
|
|
The Incidence of the Occurrence of Lower Gastrointestinal Symptoms Per GSRS Scale Ratings in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
Number of Participants without Lower GI symptoms
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Included any patient who experienced rejection while enrolled in the study up to 6 months post-transplant.
All rejection episodes of the kidney transplant were proven by kidney transplant biopsy and were measured at 24 weeks for all patients still participating in the study at that timepoint.
Outcome measures
| Measure |
Myfortic Comparator Group
n=17 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=14 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
The Incidence of Rejection in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz.
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Any patient with serum creatinine values available at 24 weeks
Serum creatinine lab values were used as part of a measure of renal function at 24 weeks for any patient that was still participating in the study at this time-point.
Outcome measures
| Measure |
Myfortic Comparator Group
n=17 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=14 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
Serum Creatinine in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
|
1.9 serum creatinine mg/dL
Standard Deviation 3.0
|
1.9 serum creatinine mg/dL
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Any patient with Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates at 24 weeks was included in the analysis
Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates were used as part of a measure of renal function and measured at 24 weeks in patients who were still participating in the study at that point.
Outcome measures
| Measure |
Myfortic Comparator Group
n=17 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=14 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
|
59.6 MDRD (mL/min/1.73m2)
Standard Deviation 22.5
|
54.8 MDRD (mL/min/1.73m2)
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: 1 and 6 monthsPopulation: Any participant who completed at least one pharmacokinetic studies was included in this analysis.
Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of enteric coated mycophenolate sodium and mycophenolate mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose).
Outcome measures
| Measure |
Myfortic Comparator Group
n=8 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=6 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
Pharmacokinetics (Mycophenolic Acid Trough Levels) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients
Mycophenolic Acid Trough (mg/L) at week 4
|
2.4 mg/L
Standard Deviation 1.6
|
1.9 mg/L
Standard Deviation 1.3
|
|
Pharmacokinetics (Mycophenolic Acid Trough Levels) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients
Mycophenolic Acid Trough(mg/L) at week 24
|
1.9 mg/L
Standard Deviation 1.5
|
1.5 mg/L
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 1 and 6 monthsPopulation: Any participant who completed at least one pharmacokinetic studies was included in this pharmacokinetic analyses.
Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of Enteric-Coated Mycophenolate Sodium or Mycophenolate Mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose).A mycophenolic acid drawn at the peak level is called C Max or maximum concentration.
Outcome measures
| Measure |
Myfortic Comparator Group
n=8 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=6 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
Pharmacokinetics (Mycophenolic Acid Maximum Concentration) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients
Mycophenolic Acid C max (mg/L) at week 24
|
6.4 mg/L
Standard Deviation 3.5
|
13.9 mg/L
Standard Deviation 6.0
|
|
Pharmacokinetics (Mycophenolic Acid Maximum Concentration) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients
Mycophenolic Acid C max (mg/L) at week 4
|
4.3 mg/L
Standard Deviation 1.5
|
10.5 mg/L
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 1 and 6 monthsPopulation: Any participant who completed at least one pharmacokinetic studies was included in this pharmacokinetic analyses.
Pharmacokinetics is the study of how a drug is absorbed and broken down in the body. Pharmacokinetics of Enteric-Coated Mycophenolate Sodium or Mycophenolate Mofetil are measured by a level called mycophenolic acid level. Mycophenolic acid levels in this pharmacokinetic study were drawn starting in the morning at time zero (immediately prior to morning dose, also known as trough), then at 0.5, 1,1.5, 2, 2.5, 3,3.5,4,6, 8 and 12 hours post dose. Data was also dose-normalized (concentration was divided by dose). A mycophenolic acid area under the curve value, also known as AUC represents drug exposure.
Outcome measures
| Measure |
Myfortic Comparator Group
n=8 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=6 Participants
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
Pharmacokinetics (Mycophenolic Acid Area Under the Curve) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients
Mycophenolic Acid AUC (mg*hr/L) at week 4
|
23.9 mg*hr/L
Standard Deviation 10.9
|
33.8 mg*hr/L
Standard Deviation 18.4
|
|
Pharmacokinetics (Mycophenolic Acid Area Under the Curve) of Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz in a Sub-set of Patients
Mycophenolic Acid AUC (mg*hr/L) at week 24
|
21.1 mg*hr/L
Standard Deviation 11.7
|
42.4 mg*hr/L
Standard Deviation 33.2
|
Adverse Events
Myfortic Comparator Group
CellCept Comparator Group
Serious adverse events
| Measure |
Myfortic Comparator Group
n=18 participants at risk
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=19 participants at risk
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
Renal and urinary disorders
graft dysfunction due to rejection
|
5.6%
1/18 • Number of events 2 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
non-infectious related diarrhea
|
11.1%
2/18 • Number of events 2 • 6 months
|
15.8%
3/19 • Number of events 3 • 6 months
|
|
Injury, poisoning and procedural complications
lymphocele
|
0.00%
0/18 • 6 months
|
10.5%
2/19 • Number of events 4 • 6 months
|
|
Renal and urinary disorders
graft failure due to antibody mediated rejection
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Vascular disorders
dialysis fistula thrombosis
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Renal and urinary disorders
urinary leak post renal transplant
|
0.00%
0/18 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
diabetic complications
|
5.6%
1/18 • Number of events 1 • 6 months
|
21.1%
4/19 • Number of events 4 • 6 months
|
|
Renal and urinary disorders
dehydration
|
0.00%
0/18 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
graft dysfunction not found to be related to rejection
|
16.7%
3/18 • Number of events 4 • 6 months
|
31.6%
6/19 • Number of events 9 • 6 months
|
|
Renal and urinary disorders
anemia managed during hospitalization
|
11.1%
2/18 • Number of events 2 • 6 months
|
15.8%
3/19 • Number of events 3 • 6 months
|
|
Renal and urinary disorders
failure to thrive
|
0.00%
0/18 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
high potassium (hyperkalemia) requiring hospitalization for management
|
5.6%
1/18 • Number of events 1 • 6 months
|
10.5%
2/19 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
cervical arthritis and related neuropathy
|
0.00%
0/18 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
vomiting
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/18 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Infections and infestations
Bacterial infections
|
33.3%
6/18 • Number of events 7 • 6 months
|
26.3%
5/19 • Number of events 5 • 6 months
|
|
Infections and infestations
Viral infections
|
5.6%
1/18 • Number of events 1 • 6 months
|
10.5%
2/19 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
wound seroma
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Cardiac disorders
heart complications
|
11.1%
2/18 • Number of events 2 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
wound complications
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Renal and urinary disorders
recurrence of renal disease
|
0.00%
0/18 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
drug induced rash
|
0.00%
0/18 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Cardiac disorders
high blood pressure
|
11.1%
2/18 • Number of events 2 • 6 months
|
0.00%
0/19 • 6 months
|
Other adverse events
| Measure |
Myfortic Comparator Group
n=18 participants at risk
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with Myfortic (enteric-coated mycophenolate sodium), Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression
|
CellCept Comparator Group
n=19 participants at risk
Patients in this group will receive Thymoglobulin (rabbit anti-thymocyte globulin) induction immunosuppression in combination with CellCept (mycophenolate mofetil) or its generic equivalent, Prograf (tacrolimus) or its generic equivalent and corticosteroid immunosuppression.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Gastrointestinal disorders
Heartburn
|
16.7%
3/18 • Number of events 3 • 6 months
|
26.3%
5/19 • Number of events 5 • 6 months
|
|
Endocrine disorders
Diabetic Complications
|
22.2%
4/18 • Number of events 4 • 6 months
|
0.00%
0/19 • 6 months
|
|
Vascular disorders
superior vena cava syndrome
|
5.6%
1/18 • Number of events 1 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
38.9%
7/18 • Number of events 7 • 6 months
|
31.6%
6/19 • Number of events 6 • 6 months
|
|
Infections and infestations
bacterial infection not requiring hospitalization
|
16.7%
3/18 • Number of events 4 • 6 months
|
0.00%
0/19 • 6 months
|
|
Gastrointestinal disorders
soft stools without diarrhea
|
5.6%
1/18 • Number of events 1 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
high potassium (hyperkalemia) not requiring hospitalization
|
27.8%
5/18 • Number of events 5 • 6 months
|
26.3%
5/19 • Number of events 5 • 6 months
|
|
Renal and urinary disorders
urinary retention not requiring hospitalization
|
5.6%
1/18 • Number of events 1 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
low white blood cell count (leukopenia)
|
22.2%
4/18 • Number of events 4 • 6 months
|
15.8%
3/19 • Number of events 3 • 6 months
|
|
Injury, poisoning and procedural complications
accidental anti-anxiety pill overdose not requiring inpatient hospitalization
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Gastrointestinal disorders
increased bowel movement frequency
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Renal and urinary disorders
delayed graft function of renal transplant
|
50.0%
9/18 • Number of events 9 • 6 months
|
42.1%
8/19 • Number of events 8 • 6 months
|
|
Gastrointestinal disorders
nausea
|
5.6%
1/18 • Number of events 1 • 6 months
|
10.5%
2/19 • Number of events 2 • 6 months
|
|
Blood and lymphatic system disorders
low platelet count (thrombocytopenia)
|
0.00%
0/18 • 6 months
|
10.5%
2/19 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
nephrotic range protein in urine (proteinuria)
|
0.00%
0/18 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Eye disorders
blurry vision
|
0.00%
0/18 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
low red blood cell count (anemia)
|
27.8%
5/18 • Number of events 5 • 6 months
|
15.8%
3/19 • Number of events 3 • 6 months
|
|
Cardiac disorders
shortness of breath and fluid related weight gain not requiring hospitalization
|
11.1%
2/18 • Number of events 2 • 6 months
|
0.00%
0/19 • 6 months
|
|
Skin and subcutaneous tissue disorders
hemmorhoids
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Musculoskeletal and connective tissue disorders
back pain after fall on ice
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Infections and infestations
viral cold infection
|
11.1%
2/18 • Number of events 2 • 6 months
|
0.00%
0/19 • 6 months
|
|
Musculoskeletal and connective tissue disorders
hip-pain
|
11.1%
2/18 • Number of events 2 • 6 months
|
0.00%
0/19 • 6 months
|
|
Endocrine disorders
tertiary hyperparathyroidism
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Surgical and medical procedures
root canal
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Blood and lymphatic system disorders
high hemoglobin
|
5.6%
1/18 • Number of events 1 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Hepatobiliary disorders
mild increase in liver function tests (transaminitis)
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Endocrine disorders
hypoglycemia (low blood sugars)
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Injury, poisoning and procedural complications
bled through non-functioning dialysis graft not requiring inpatient hospitalization
|
0.00%
0/18 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Infections and infestations
bk virus infection
|
5.6%
1/18 • Number of events 1 • 6 months
|
10.5%
2/19 • Number of events 2 • 6 months
|
|
Cardiac disorders
high cholesterol (hyperlipidemia)
|
0.00%
0/18 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/18 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
skin itching thought to be related to dry skin
|
5.6%
1/18 • Number of events 1 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
metabolic acidosis
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Renal and urinary disorders
blood in urine and mild transplant rejection
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Renal and urinary disorders
renal dysfunction and edema
|
5.6%
1/18 • Number of events 1 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
low phosphorous
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Gastrointestinal disorders
bowel urgency
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
General disorders
unilateral lower leg swelling
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Metabolism and nutrition disorders
low potassium
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Immune system disorders
neck itching
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Musculoskeletal and connective tissue disorders
muscle leg pain
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Cardiac disorders
ongoing high blood pressure
|
5.6%
1/18 • Number of events 1 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
General disorders
hot flashes
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Injury, poisoning and procedural complications
lymphocele or seroma
|
5.6%
1/18 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place