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Trial record 39 of 1164 for:    MYCOPHENOLIC ACID

A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant 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: NCT00336817
Recruitment Status : Completed
First Posted : June 14, 2006
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Roberto Lopez, MD, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Immunosuppression
Interventions Drug: Myfortic
Drug: CellCept
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Period Title: Overall Study
Started 15 15
Completed 14 13
Not Completed 1 2
Arm/Group Title Myfortic Group CellCept Group Total
Hide Arm/Group Description

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Total of all reporting groups
Overall Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  85.7%
10
  66.7%
22
  75.9%
>=65 years
2
  14.3%
5
  33.3%
7
  24.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 29 participants
54.6  (12.75408) 58.2  (8.83338) 56.4333  (10.92824)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
Female
2
  14.3%
8
  53.3%
10
  34.5%
Male
12
  85.7%
7
  46.7%
19
  65.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 15 participants 29 participants
15 15 30
1.Primary Outcome
Title GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil
Hide Description

The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).

The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The total GSRS range of scores is 15 to 105 with higher scores meaning the worst of symptoms.

Time Frame screening, 2, 6 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in the myfortic group was ineligible
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description:

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
screening 21.80  (4.37) 23.07  (6.04)
2 weeks 24.90  (5.47) 22.14  (5.08)
6 weeks 28.90  (16.10) 26.07  (15.72)
12 weeks 21.80  (7.30) 25.21  (15.95)
2.Primary Outcome
Title GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Abdominal Pain Subscale)
Hide Description

The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).

The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.

The abdominal Pain subscale range is 3 to 21 with higher scores means worst symptoms

Time Frame screening, 2, 6 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description:

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
screening 5.20  (1.81) 5.29  (1.63)
2 weeks 5.80  (1.75) 4.79  (1.12)
6 weeks 6.40  (3.44) 5.93  (4.20)
12 weeks 5.30  (2.67) 5.36  (3.41)
3.Primary Outcome
Title GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Reflux Subscale)
Hide Description

The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).

The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.

Reflux subscale range is 2 to 14 with higher scores means worst symptoms

Time Frame screening, 2, 6 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description:

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
screening 2.70  (1.060) 3.07  (1.54)
2 weeks 2.90  (1.66) 2.36  (0.75)
6 weeks 2.90  (1.73) 3.36  (2.73)
12 weeks 2.70  (1.34) 3.07  (1.86)
4.Primary Outcome
Title GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Indigestion Subscale)
Hide Description

The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).

The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.

The Indigestion subscale range is 4 to 28 with higher scores means worst symptoms

Time Frame screening, 2, 6 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description:

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
screening 5.40  (1.174) 5.86  (2.68)
2 weeks 5.80  (1.75) 6.43  (3.94)
6 weeks 6.50  (3.84) 7.50  (5.72)
12 weeks 5.60  (2.75) 6.86  (4.94)
5.Primary Outcome
Title GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Diarrhea Subscale)
Hide Description

The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).

The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.

The Diarrhea subscale range is 3 to 21 with higher scores means worst symptoms

Time Frame screening, 2, 6 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description:

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
screening 4.00  (1.15) 4.79  (1.85)
2 weeks 5.80  (2.78) 4.36  (1.39)
6 weeks 6.60  (4.40) 4.50  (2.31)
12 weeks 3.70  (0.95) 5.29  (3.29)
6.Primary Outcome
Title GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Constipation Subscale)
Hide Description

The GSRS contains 15 items, each rated on a seven-point Likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items break down into the following five scale: abdominal pain syndrome ( abdominal pain, hunger pains, and nausea); reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation).

The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.

Constipation subscale range is 3 to 21 with higher scores means worst symptoms

Time Frame screening, 2, 6 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description:

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Overall Number of Participants Analyzed 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
screening 4.50  (2.01) 4.07  (1.63)
2 weeks 4.60  (1.43) 4.21  (1.83)
6 weeks 6.50  (4.79) 4.79  (3.33)
12 weeks 4.50  (2.12) 4.54  (3.41)
7.Primary Outcome
Title Number of Participants With Bone Marrow Suppression
Hide Description Number of participants with: Thrombocytopenia (<50,000 mm3), Leukopenia (< 2000 mm3), absolute neutrophils count ( <1000 mm3) or hemoglobin ( < 7.0 g/dL)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description:

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: participants
0 0
8.Primary Outcome
Title Incidence of Cytomegalovirus Infection or Disease During the Study Period
Hide Description number of participants
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description:

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: participants
0 0
9.Secondary Outcome
Title Drug Discontinuation Due to Side Effects
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description:

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Results: 1 participant in the Myfortic arm left at 6 weeks into the study to start hemodialysis

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Results: 2 participants in the CellCept group discontinued drug use

Overall Number of Participants Analyzed 14 15
Measure Type: Count of Participants
Unit of Measure: Participants
1
   7.1%
2
  13.3%
10.Secondary Outcome
Title Number of Participants With Clinically Significant Decrease in Serum Creatinine From Baseline Through Week 12
Hide Description Creatinine levels
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description:

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Results: 1 participant in the Myfortic arm left at 6 weeks into the study to start hemodialysis

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Results: 2 participants in the CellCept group discontinued drug use

Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: participants
0 0
11.Secondary Outcome
Title Number of Participants With Neurotoxicity
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description:

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: participants
0 0
12.Other Pre-specified Outcome
Title Incidence of Graft Loss or Death During the Study Period
Hide Description number of patients
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description:

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: participants
0 0
13.Other Pre-specified Outcome
Title Incidence of Biopsy-proven Acute Cellular Rejection During the Study Period
Hide Description number of patients with ACR
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description:

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: participants
2 1
Time Frame screening to 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Myfortic Group CellCept Group
Hide Arm/Group Description

Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days

Myfortic: Myfortic 360mg or 720 mg BID for 90 days

Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

CellCept: CellCept 500mg or 1000mg BID for 90 days

All-Cause Mortality
Myfortic Group CellCept Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Myfortic Group CellCept Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Myfortic Group CellCept Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
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: Dr. Roberto Lopez-Solis
Organization: Upittsburgh
Phone: 412-647-5173
Responsible Party: Roberto Lopez, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00336817     History of Changes
Other Study ID Numbers: CERL080A-US26
First Submitted: June 12, 2006
First Posted: June 14, 2006
Results First Submitted: May 23, 2016
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017