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Trial record 9 of 1164 for:    MYCOPHENOLIC ACID

Myfortic or CellCept Gastrointestinal Effects in African American Kidney Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00522548
Recruitment Status : Terminated (enrollment halted in order to have all patients complete follow-up by Jan 2011)
First Posted : August 29, 2007
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Roy D. Bloom, MD, University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Transplants and Implants
Interventions Drug: Enteric coated mycophenolate sodium
Drug: Mycophenolate mofetil
Enrollment 37
Recruitment Details 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.
Pre-assignment Details Patients were not randomized until they were transplanted.
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 18 19
Consented to Pharmacokinetic Study 11 10
Completed 0/2 PK Visits 3 4
Completed 1/2 PK Visits 1 1
Completed 2/2 PK Visits 7 5
Completed 16 15
Not Completed 2 4
Reason Not Completed
Adverse Event             2             2
Withdrawal by Subject             0             2
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 18 19 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
 100.0%
19
 100.0%
37
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 19 participants 37 participants
47.9  (9.3) 52.4  (13.0) 50.3  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
Female
7
  38.9%
6
  31.6%
13
  35.1%
Male
11
  61.1%
13
  68.4%
24
  64.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 19 participants 37 participants
18 19 37
1.Primary Outcome
Title Gastrointestinal Toxicity Due to Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the number of patients who were participating in the trial at that timepoint and had not withdrawn at 24 weeks
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 17 14
Measure Type: Number
Unit of Measure: participants
9 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .29
Comments A p value of less than 0.05 was considered statistically significant.
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Based on number of patients participating in study at 6 months
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 17 14
Measure Type: Number
Unit of Measure: participants
3 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments A p value of less than 0.05 was considered statistically significant.
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Based on number of patients participating in the study at 6 months
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 17 14
Measure Type: Number
Unit of Measure: participants
1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments A p value of less than 0.05 was considered statistically significant.
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title 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
Hide Description 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.
Time Frame baseline (pre-transplant to two days after transplant) and at 6 months after transplant.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who withdrew from the study before 24 weeks were excluded from this analysis.
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 17 14
Measure Type: Count of Participants
Unit of Measure: Participants
Worsening of GSRS Score pre-transplant-wk 24
4
  23.5%
4
  28.6%
No Worsening of GSRS Score pre-transplant-wk 24
13
  76.5%
10
  71.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments A p value of less than 0.05 was considered significant.
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Any patient with mean GSRS subscale score >1 from dimensions: abdominal pain, indigestion, or reflux were considered to have upper GI symptoms.
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 17 14
Measure Type: Count of Participants
Unit of Measure: Participants
Number of Participants with Upper GI symptoms
8
  47.1%
11
  78.6%
Number of Participants without Upper GI symptoms
9
  52.9%
3
  21.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments a p value of less than 0.05 was considered statistically significant
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Any patient with a mean GSRS subscale score > 1 on dimensions constipation or diarrhea were considered to have lower GI symptoms.
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 17 14
Measure Type: Count of Participants
Unit of Measure: Participants
Number of Participants with Lower GI symptoms
8
  47.1%
9
  64.3%
Number of Participants without Lower GI symptoms
9
  52.9%
5
  35.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments A p value of less than 0.05 was considered statistically significant.
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title The Incidence of Rejection in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz.
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Included any patient who experienced rejection while enrolled in the study up to 6 months post-transplant.
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 17 14
Measure Type: Number
Unit of Measure: participants
2 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .51
Comments A p-value of less than 0.05 was considered statistically significant.
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Serum Creatinine in Patients on Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Manufactured by Sandoz
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Any patient with serum creatinine values available at 24 weeks
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 17 14
Mean (Standard Deviation)
Unit of Measure: serum creatinine mg/dL
1.9  (3.0) 1.9  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments A p-value of less than 0.05 was considered statistically significant.
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Any patient with Modification of Diet and Renal Disease (MDRD) Measured Glomerular Filtration Rates at 24 weeks was included in the analysis
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 17 14
Mean (Standard Deviation)
Unit of Measure: MDRD (mL/min/1.73m2)
59.6  (22.5) 54.8  (20.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments The p value was not adjusted for multiple comparisons. A p-value of less than 0.05 was considered statistically significant.
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title 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
Hide Description 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).
Time Frame 1 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Any participant who completed at least one pharmacokinetic studies was included in this analysis.
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: mg/L
Mycophenolic Acid Trough (mg/L) at week 4 Number Analyzed 8 participants 6 participants
2.4  (1.6) 1.9  (1.3)
Mycophenolic Acid Trough(mg/L) at week 24 Number Analyzed 7 participants 5 participants
1.9  (1.5) 1.5  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments This represents p value for week 4 data. A p value of less than 0.05 was considered significant.
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in CellCept group and 20 in the Myfortic group) in this proof of concept study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments This represents p value for week 24 data. A p value of less than 0.05 was considered significant.
Method Kruskal-Wallis
Comments [Not Specified]
11.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 1 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Any participant who completed at least one pharmacokinetic studies was included in this pharmacokinetic analyses.
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: mg/L
Mycophenolic Acid C max (mg/L) at week 4 Number Analyzed 8 participants 6 participants
4.3  (1.5) 10.5  (4.1)
Mycophenolic Acid C max (mg/L) at week 24 Number Analyzed 7 participants 5 participants
6.4  (3.5) 13.9  (6.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments This p value is for data at week 4. A p value of less than 0.05 was considered significant.
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic Group) in this proof of concept study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments This p value was for data at week 24. A p value of less than 0.05 was considered significant.
Method Kruskal-Wallis
Comments [Not Specified]
12.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 1 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Any participant who completed at least one pharmacokinetic studies was included in this pharmacokinetic analyses.
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: mg*hr/L
Mycophenolic Acid AUC (mg*hr/L) at week 4 23.9  (10.9) 33.8  (18.4)
Mycophenolic Acid AUC (mg*hr/L) at week 24 21.1  (11.7) 42.4  (33.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments p value represents data for week 4. A p value of less than 0.05 was considered significant.
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Myfortic Comparator Group, CellCept Comparator Group
Comments Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments p value represents data for week 24. A p value of less than 0.05 was considered significant.
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Myfortic Comparator Group CellCept Comparator Group
Hide Arm/Group Description 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 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.
All-Cause Mortality
Myfortic Comparator Group CellCept Comparator Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Myfortic Comparator Group CellCept Comparator Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/18 (100.00%)      19/19 (100.00%)    
Blood and lymphatic system disorders     
thrombocytopenia   0/18 (0.00%)  0 1/19 (5.26%)  1
Cardiac disorders     
heart complications  [1]  2/18 (11.11%)  2 1/19 (5.26%)  1
high blood pressure   2/18 (11.11%)  2 0/19 (0.00%)  0
Gastrointestinal disorders     
non-infectious related diarrhea   2/18 (11.11%)  2 3/19 (15.79%)  3
vomiting  [2]  1/18 (5.56%)  1 0/19 (0.00%)  0
Infections and infestations     
Bacterial infections  [3]  6/18 (33.33%)  7 5/19 (26.32%)  5
Viral infections  [3]  1/18 (5.56%)  1 2/19 (10.53%)  2
Injury, poisoning and procedural complications     
lymphocele   0/18 (0.00%)  0 2/19 (10.53%)  4
wound seroma  [4]  1/18 (5.56%)  1 0/19 (0.00%)  0
Metabolism and nutrition disorders     
diabetic complications   1/18 (5.56%)  1 4/19 (21.05%)  4
high potassium (hyperkalemia) requiring hospitalization for management   1/18 (5.56%)  1 2/19 (10.53%)  2
Musculoskeletal and connective tissue disorders     
cervical arthritis and related neuropathy   0/18 (0.00%)  0 1/19 (5.26%)  1
Leg pain  [5]  1/18 (5.56%)  1 0/19 (0.00%)  0
Renal and urinary disorders     
graft dysfunction due to rejection   1/18 (5.56%)  2 1/19 (5.26%)  1
graft failure due to antibody mediated rejection  [6]  1/18 (5.56%)  1 0/19 (0.00%)  0
urinary leak post renal transplant   0/18 (0.00%)  0 1/19 (5.26%)  1
dehydration   0/18 (0.00%)  0 1/19 (5.26%)  1
graft dysfunction not found to be related to rejection  [7]  3/18 (16.67%)  4 6/19 (31.58%)  9
anemia managed during hospitalization   2/18 (11.11%)  2 3/19 (15.79%)  3
failure to thrive   0/18 (0.00%)  0 1/19 (5.26%)  1
recurrence of renal disease  [8]  0/18 (0.00%)  0 1/19 (5.26%)  1
Skin and subcutaneous tissue disorders     
drug induced rash  [9]  0/18 (0.00%)  0 1/19 (5.26%)  1
Surgical and medical procedures     
wound complications  [10]  1/18 (5.56%)  1 0/19 (0.00%)  0
Vascular disorders     
dialysis fistula thrombosis  [11]  1/18 (5.56%)  1 0/19 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
non-sustained ventricular tachycardia, pericardial effusion, myocardial infarction
[2]
patient redmitted for dehydration and vomiting
[3]
infection
[4]
wound seroma
[5]
unrelated to vascular complications or infection
[6]
Occurred during 30 day safety follow-up period when patient was found to be non-adherent with immunosuppression. Antibody mediated rejection was considered non-reversible and patient progressed to graft failure.
[7]
causes included acute tubular necrosis, chronic allograft nephropathy, recurrent focal segmental glomerulosclerosis
[8]
recurrent primary disease FSGS
[9]
thought to be related to rabbit anti-thymocyte globulin induction
[10]
wound vac placement
[11]
Patient had dialysis fistula thrombosis during treatment for antibody mediated rejection that progressed to graft failure in 30 day safety follow-up period due to non-adherence.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Myfortic Comparator Group CellCept Comparator Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/18 (100.00%)      17/19 (89.47%)    
Blood and lymphatic system disorders     
low white blood cell count (leukopenia)   4/18 (22.22%)  4 3/19 (15.79%)  3
low platelet count (thrombocytopenia)   0/18 (0.00%)  0 2/19 (10.53%)  2
low red blood cell count (anemia)   5/18 (27.78%)  5 3/19 (15.79%)  3
high hemoglobin  [1]  1/18 (5.56%)  1 1/19 (5.26%)  1
Cardiac disorders     
shortness of breath and fluid related weight gain not requiring hospitalization   2/18 (11.11%)  2 0/19 (0.00%)  0
high cholesterol (hyperlipidemia)  [2]  0/18 (0.00%)  0 1/19 (5.26%)  1
ongoing high blood pressure  [3]  1/18 (5.56%)  1 1/19 (5.26%)  1
Endocrine disorders     
Diabetic Complications  [4]  4/18 (22.22%)  4 0/19 (0.00%)  0
tertiary hyperparathyroidism  [5]  1/18 (5.56%)  1 0/19 (0.00%)  0
hypoglycemia (low blood sugars)  [6]  1/18 (5.56%)  1 0/19 (0.00%)  0
Eye disorders     
blurry vision  [7]  0/18 (0.00%)  0 1/19 (5.26%)  1
Gastrointestinal disorders     
Heartburn   3/18 (16.67%)  3 5/19 (26.32%)  5
Diarrhea   7/18 (38.89%)  7 6/19 (31.58%)  6
soft stools without diarrhea   1/18 (5.56%)  1 1/19 (5.26%)  1
increased bowel movement frequency   1/18 (5.56%)  1 0/19 (0.00%)  0
nausea  [8]  1/18 (5.56%)  1 2/19 (10.53%)  2
abdominal pain  [9]  0/18 (0.00%)  0 1/19 (5.26%)  1
bowel urgency   1/18 (5.56%)  1 0/19 (0.00%)  0
General disorders     
unilateral lower leg swelling  [10]  1/18 (5.56%)  1 0/19 (0.00%)  0
hot flashes   1/18 (5.56%)  1 0/19 (0.00%)  0
Hepatobiliary disorders     
mild increase in liver function tests (transaminitis)  [11]  1/18 (5.56%)  1 0/19 (0.00%)  0
Immune system disorders     
neck itching  [12]  1/18 (5.56%)  1 0/19 (0.00%)  0
Infections and infestations     
bacterial infection not requiring hospitalization  [13]  3/18 (16.67%)  4 0/19 (0.00%)  0
viral cold infection  [14]  2/18 (11.11%)  2 0/19 (0.00%)  0
bk virus infection  [15]  1/18 (5.56%)  1 2/19 (10.53%)  2
Injury, poisoning and procedural complications     
accidental anti-anxiety pill overdose not requiring inpatient hospitalization   1/18 (5.56%)  1 0/19 (0.00%)  0
bled through non-functioning dialysis graft not requiring inpatient hospitalization   0/18 (0.00%)  0 1/19 (5.26%)  1
lymphocele or seroma  [16]  1/18 (5.56%)  1 0/19 (0.00%)  0
Metabolism and nutrition disorders     
high potassium (hyperkalemia) not requiring hospitalization   5/18 (27.78%)  5 5/19 (26.32%)  5
low phosphorous  [17]  1/18 (5.56%)  1 0/19 (0.00%)  0
low potassium  [18]  1/18 (5.56%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle cramps   1/18 (5.56%)  1 0/19 (0.00%)  0
back pain after fall on ice   1/18 (5.56%)  1 0/19 (0.00%)  0
hip-pain  [19]  2/18 (11.11%)  2 0/19 (0.00%)  0
muscle leg pain  [20]  1/18 (5.56%)  1 0/19 (0.00%)  0
Renal and urinary disorders     
urinary retention not requiring hospitalization   1/18 (5.56%)  1 1/19 (5.26%)  1
delayed graft function of renal transplant   9/18 (50.00%)  9 8/19 (42.11%)  8
nephrotic range protein in urine (proteinuria)   0/18 (0.00%)  0 1/19 (5.26%)  1
metabolic acidosis  [21]  1/18 (5.56%)  1 0/19 (0.00%)  0
blood in urine and mild transplant rejection  [22]  1/18 (5.56%)  1 0/19 (0.00%)  0
renal dysfunction and edema  [23]  1/18 (5.56%)  1 1/19 (5.26%)  1
Skin and subcutaneous tissue disorders     
hemmorhoids   1/18 (5.56%)  1 0/19 (0.00%)  0
skin itching thought to be related to dry skin   1/18 (5.56%)  1 1/19 (5.26%)  1
Surgical and medical procedures     
root canal   1/18 (5.56%)  1 0/19 (0.00%)  0
Vascular disorders     
superior vena cava syndrome   1/18 (5.56%)  1 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
[1]
treated with outpatient phlebotomy
[2]
Patient was on maximum statin dose. Symptoms resolved with diet, exercise and decreased prednisone dose.
[3]
ongoing high blood pressure on medications
[4]
worsening pre-transpalnt diabets blood sugar control
[5]
treated with oral medication as outpatient
[6]
patient was using sliding scale for elevated blood sugars but experienced hypoglycemia-resolved upon stopping insulin and patient did not need any further therapy
[7]
did not require any intervention and resolved on own
[8]
nausea resulted in subsequent weight loss not requiring hospitalization in one cellcept patient and associated also with vomiting in one patient on cellcept
[9]
symptoms improved over time without any specific treatment
[10]
not transplant related and negative for deep vein thrombosis
[11]
patient had history of pre-transplant hepatitis B infection
[12]
patient thought symptoms may be related to allergy and resolved with otc medication product change.
[13]
urinary tract infection
[14]
resolved on its own without treatment
[15]
was BKV nephropathy in one myfortic patient
[16]
stable on outpatient ultrasound
[17]
corrected with diet
[18]
resolved with change in diet
[19]
no source found in one patient and other patient had history of pre-transplant avascular necrosis
[20]
resolved with prescription muscle relaxant
[21]
treated as outpatient with oral bicarbonate and resolved
[22]
treated as outpatient with pulse steroid doses
[23]
found to be related to SVC in 30+ day follow-up in MMF group patient
Limitations of our study include small sample size and patient drop out-though not significantly different between the MMF and EC-MPS groups and limited follow-up
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Roy Bloom, MD
Organization: University of Pennsylvania
Phone: 215-662-4643
Responsible Party: Roy D. Bloom, MD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00522548     History of Changes
Other Study ID Numbers: CERL080A-US49
First Submitted: August 27, 2007
First Posted: August 29, 2007
Results First Submitted: July 23, 2013
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018