A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00336817
• Collaborator: Novartis Pharmaceuticals (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The objective of this study is to compare the safety and efficacy of Myfortic with CellCept in liver transplant patients. Myfortic and CellCept are both immunosuppressive (anti-rejection) drugs. CellCept is commonly used after liver transplantation but gastrointestinal (GI) side effects are very common, sometimes necessitating in its discontinuation. Myfortic is a new drug similar to CellCept, except it is enteric-coated. Our hypothesis is that Myfortic has less GI side effects than CellCept and also has comparable effectiveness to CellCept.

Condition or Disease	Intervention/Treatment	Phase
Immunosuppression	Drug: Myfortic; Drug: CellCept	N/A

Detailed Description

This is a prospective, randomized, double-blinded, single center, safety and efficacy study comparing Myfortic with CellCept used after liver transplantation. Patients with biopsy-proven acute cellular rejection, renal insufficiency (i.e. acute or chronic renal failure requiring hemodialysis or patients with creatinine clearance < 50 ml/min), or calcineurin inhibitor-induced neurotoxicity (defined as the presence of neurologic symptoms such as tremors, altered mental status, seizures, etc) will be randomized to start on either Myfortic (720 mg po bid) or CellCept (1 gm po bid). In those patients with calcineurin-induced neurotoxicity or nephrotoxicity, tacrolimus or cyclosporine doses will also be reduced to maintain serum trough levels of 4-8 mg/dl or 100-200 mg/dl, respectively.

Comparison: Thirty patients will be enrolled and randomized in this two-armed, double-blinded study- half of the patients will receive Myfortic and the other half, CellCept.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Myfortic Group Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days	Drug: Myfortic; Myfortic 360mg or 720 mg BID for 90 days
Active Comparator: CellCept Group Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days	Drug: CellCept; CellCept 500mg or 1000mg BID for 90 days

Outcome Measures

Primary Outcome Measures

1. GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil [screening, 2, 6 and 12 weeks]

   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.

2. GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Abdominal Pain Subscale) [screening, 2, 6 and 12 weeks]

   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

3. GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Reflux Subscale) [screening, 2, 6 and 12 weeks]

   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

4. GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Indigestion Subscale) [screening, 2, 6 and 12 weeks]

   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

5. GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Diarrhea Subscale) [screening, 2, 6 and 12 weeks]

   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

6. GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Constipation Subscale) [screening, 2, 6 and 12 weeks]

   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

7. Number of Participants With Bone Marrow Suppression [12 weeks]

   Number of participants with: Thrombocytopenia (<50,000 mm3), Leukopenia (< 2000 mm3), absolute neutrophils count ( <1000 mm3) or hemoglobin ( < 7.0 g/dL)

8. Incidence of Cytomegalovirus Infection or Disease During the Study Period [12 weeks]

   number of participants

Secondary Outcome Measures

1. Drug Discontinuation Due to Side Effects [12 weeks]

   Drug discontinuation due to drug side effects regarding Cellcept and Myfortic.

2. Number of Participants With Clinically Significant Decrease in Serum Creatinine From Baseline Through Week 12 [12 weeks]

   Creatinine levels

3. Number of Participants With Neurotoxicity [12 weeks]

Other Outcome Measures

1. Incidence of Graft Loss or Death During the Study Period [12 weeks]

   number of patients

2. Incidence of Biopsy-proven Acute Cellular Rejection During the Study Period [12 weeks]

   number of patients with ACR

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age.

• Patients must be 30 to 180 days (1 to 6 months) post-transplant to be eligible.

• Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen.

• Patients with renal insufficiency (history of renal insufficiency or renal failure in the past, patients on hemodialysis, patients with a rising creatinine post-transplant).

• Patients with biopsy-proven acute cellular rejection (mild, moderate, or severe based on Rejection Activity Index (RAI) as graded by pathologists at UPMC) or repeated bouts of rejection (greater than 2 episodes within a 30 day period).

• Patients with tacrolimus- or cyclosporine-induced neurotoxicity.

• Females of childbearing potential must have a negative serum pregnancy test prior to the inclusion period.

Exclusion Criteria:

• Multi-organ transplant patients.

• HIV positive patients.

• Living-related liver transplant recipients

• Pregnant patients and nursing mothers.

• Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.

• Patients with thrombocytopenia (<50,000/mm3), with an absolute neutrophil count of <1,000/mm3 and/or leukocytopenia (<2,000/mm3), and/or hemoglobin <7.0 g/dL prior to enrollment.

• Presence of clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus.

• Evidence of drug and/or alcohol abuse.

• Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• Novartis Pharmaceuticals

Investigators

• Principal Investigator: Michael E de Vera, MD, University of Pittsburgh Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roberto Lopez, MD, Assistant Professor of Surgery, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00336817
• Other Study ID Numbers: CERL080A-US26
• First Posted: Jun 14, 2006
• Last Update Posted: Mar 9, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Roberto Lopez, MD, Assistant Professor of Surgery, University of Pittsburgh: Liver transplantation; mycophenolate mofetil; gastrointestinal; adverse effects
• Additional relevant MeSH terms: Mycophenolic Acid

Study Results

Participant Flow

Arm/Group Title	Myfortic Group	CellCept Group
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

Baseline Characteristics

Arm/Group Title	Myfortic Group	CellCept Group	Total
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 Participants	14	15	29
Age (Count of Participants)
<=18 years	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 (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.6 (12.75408)	58.2 (8.83338)	56.4333 (10.92824)
Sex: Female, Male (Count of Participants)
Female	2 14.3%	8 53.3%	10 34.5%
Male	12 85.7%	7 46.7%	19 65.5%
Region of Enrollment (participants) [Number]
United States	15 107.1%	15 100%	30 103.4%

Outcome Measures

1. Primary Outcome

Title	GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil
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

Outcome Measure Data

Analysis Population Description

One participant in the myfortic group was ineligible

Arm/Group Title	Myfortic Group	CellCept Group
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
Measure Participants	14	15
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myfortic Group	CellCept Group
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
Measure Participants	14	15
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myfortic Group	CellCept Group
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
Measure Participants	14	15
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myfortic Group	CellCept Group
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
Measure Participants	14	15
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myfortic Group	CellCept Group
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
Measure Participants	14	15
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myfortic Group	CellCept Group
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
Measure Participants	14	15
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myfortic Group	CellCept Group
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
Measure Participants	14	15
Number [participants]	0 0%	0 0%

8. Primary Outcome

Title	Incidence of Cytomegalovirus Infection or Disease During the Study Period
Description	number of participants
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myfortic Group	CellCept Group
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
Measure Participants	14	15
Number [participants]	0 0%	0 0%

9. Secondary Outcome

Title	Drug Discontinuation Due to Side Effects
Description	Drug discontinuation due to drug side effects regarding Cellcept and Myfortic.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myfortic Group	CellCept Group
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
Measure Participants	14	15
Count of Participants [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
Description	Creatinine levels
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myfortic Group	CellCept Group
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
Measure Participants	14	15
Number [participants]	0 0%	0 0%

11. Secondary Outcome

Title	Number of Participants With Neurotoxicity
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myfortic Group	CellCept Group
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
Measure Participants	14	15
Number [participants]	0 0%	0 0%

12. Other Pre-specified Outcome

Title	Incidence of Graft Loss or Death During the Study Period
Description	number of patients
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myfortic Group	CellCept Group
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
Measure Participants	14	15
Number [participants]	0 0%	0 0%

13. Other Pre-specified Outcome

Title	Incidence of Biopsy-proven Acute Cellular Rejection During the Study Period
Description	number of patients with ACR
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myfortic Group	CellCept Group
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
Measure Participants	14	15
Number [participants]	2 14.3%	1 6.7%

Adverse Events

Time Frame	screening to 12 weeks
Arm/Group Title	Myfortic Group		CellCept Group
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Myfortic Group		CellCept Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Myfortic Group		CellCept Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.