Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00118742
Collaborator
(none)
293
46
2
40
6.4
0.2
Study Details
Study Description
Brief Summary
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500 individuals.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
293 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label Study of the Effect of a Long-term Calcineurin Inhibitor-free Maintenance Regimen With CellCept and Sirolimus on Preservation of Renal Function and Prevention of Acute Rejection in Recipients of an Orthotropic Liver Transplant
Study Start Date
:
Aug 1, 2005
Actual Primary Completion Date
:
Jul 1, 2008
Actual Study Completion Date
:
Dec 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CellCept + CNI (tacrolimus or cyclosporine)
|
Drug: mycophenolate mofetil [CellCept]
1-1.5 g orally or intravenously twice daily
Drug: Tacrolimus
As prescribed, for 12 months
Drug: Cyclosporine
As prescribed, for 12 months
|
| Active Comparator: CellCept + sirolimus
|
Drug: mycophenolate mofetil [CellCept]
1-1.5 g orally or intravenously twice daily
Drug: Sirolimus
2-4 mg orally once daily for 9-11 months
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant [12 months posttransplant]
Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.
Secondary Outcome Measures
- Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant [6 months posttransplant]
Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.
- Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant [24 months posttransplant]
Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.
- Change From Baseline in Creatinine Clearance [6, 12, and 24 months posttransplantation]
Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Adult patients 18-74 years of age
-
Single primary liver transplant from a deceased donor
-
CellCept plus tacrolimus or cyclosporine from time of transplantation (within 72 hours)
-
Patients with hepatitis C-positive status may be entered if they have had an intraoperative (back table) biopsy of the transplanted liver or will have a biopsy at the time of randomization. This is not required for patients negative for hepatitis C.
Exclusion Criteria:
-
Liver allograft from a living donor or a split liver
-
Multiple organ transplant
-
Dialysis therapy for >14 days from transplantation to randomization
-
History of malignancy in the last 5 years (except hepatoma or non-melanoma skin cancer)
-
Previous sirolimus therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | 35294 | |
| 2 | Phoenix | Arizona | United States | 85054 | |
| 3 | La Jolla | California | United States | 92037 | |
| 4 | Los Angeles | California | United States | 90033-4612 | |
| 5 | Los Angeles | California | United States | 90095 | |
| 6 | San Diego | California | United States | 92103-8401 | |
| 7 | San Francisco | California | United States | 94115 | |
| 8 | San Francisco | California | United States | 94143-0780 | |
| 9 | Denver | Colorado | United States | 80262 | |
| 10 | Jacksonville | Florida | United States | 32216 | |
| 11 | Miami | Florida | United States | 33136 | |
| 12 | Tampa | Florida | United States | 33606 | |
| 13 | Atlanta | Georgia | United States | 30322 | |
| 14 | Chicago | Illinois | United States | 60611 | |
| 15 | Chicago | Illinois | United States | 60612-3824 | |
| 16 | New Orleans | Louisiana | United States | 70121 | |
| 17 | Baltimore | Maryland | United States | 21201 | |
| 18 | Boston | Massachusetts | United States | 02111 | |
| 19 | Boston | Massachusetts | United States | 02114-2696 | |
| 20 | Boston | Massachusetts | United States | 02215 | |
| 21 | Burlington | Massachusetts | United States | 01805 | |
| 22 | Detroit | Michigan | United States | 48202-2689 | |
| 23 | Minneapolis | Minnesota | United States | 55455 | |
| 24 | Rochester | Minnesota | United States | 55905 | |
| 25 | St Louis | Missouri | United States | 63110 | |
| 26 | Newark | New Jersey | United States | 07101-1709 | |
| 27 | Hawthorne | New York | United States | 10532 | |
| 28 | New York | New York | United States | 10016 | |
| 29 | New York | New York | United States | 10029 | |
| 30 | New York | New York | United States | 10032 | |
| 31 | Chapel Hill | North Carolina | United States | 27599 | |
| 32 | Cleveland | Ohio | United States | 44195 | |
| 33 | Oklahoma City | Oklahoma | United States | 73112-4481 | |
| 34 | Portland | Oregon | United States | 97201-3098 | |
| 35 | Philadelphia | Pennsylvania | United States | 19141 | |
| 36 | Nashville | Tennessee | United States | 37232 | |
| 37 | Dallas | Texas | United States | 75246 | |
| 38 | Houston | Texas | United States | 77030 | |
| 39 | San Antonio | Texas | United States | 78284 | |
| 40 | Richmond | Virginia | United States | 23298 | |
| 41 | Madison | Wisconsin | United States | 53792 | |
| 42 | Edmonton | Alberta | Canada | T6G 2B7 | |
| 43 | Halifax | Nova Scotia | Canada | B3H 3A7 | |
| 44 | London | Ontario | Canada | N6A 5A5 | |
| 45 | Montreal | Quebec | Canada | H2X 3J4 | |
| 46 | Montreal | Quebec | Canada | H3A 1A1 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00118742
Other Study ID Numbers:
- ML18423
First Posted:
Jul 12, 2005
Last Update Posted:
Aug 3, 2010
Last Verified:
Jul 1, 2010
Study Results
Participant Flow
| Recruitment Details | Patients were recruited from 43 study centers in the US and Canada over a period of 3 years (24-Aug-05 to 03-Jul-08) |
|---|---|
| Pre-assignment Detail | Eligible for the study were adult patients (18 to 74 years) who had received a single primary orthotopic liver transplant and were receiving or were scheduled to receive treatment with CellCept® + calcineurin inhibitor (CNI) |
| Arm/Group Title | CellCept + CNI (Tacrolimus or Cyclosporine) | CellCept + Sirolimus |
|---|---|---|
| Arm/Group Description | CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months | CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months |
| Period Title: Overall Study | ||
| STARTED | 145 | 148 |
| COMPLETED | 96 | 82 |
| NOT COMPLETED | 49 | 66 |
Baseline Characteristics
| Arm/Group Title | CellCept + CNI (Tacrolimus or Cyclosporine) | CellCept + Sirolimus | Total |
|---|---|---|---|
| Arm/Group Description | CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months | CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months | Total of all reporting groups |
| Overall Participants | 145 | 148 | 293 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
53.4
(7.88)
|
53.2
(8.83)
|
53.3
(8.36)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
35
24.1%
|
38
25.7%
|
73
24.9%
|
| Male |
110
75.9%
|
110
74.3%
|
220
75.1%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| American Indian |
3
2.1%
|
4
2.7%
|
7
2.4%
|
| Asian or Pacific Islander |
3
2.1%
|
11
7.4%
|
14
4.8%
|
| Black |
11
7.6%
|
8
5.4%
|
19
6.5%
|
| White |
126
86.9%
|
125
84.5%
|
251
85.7%
|
| Other |
2
1.4%
|
0
0%
|
2
0.7%
|
| Height (cm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [cm] |
173.6
(10.04)
|
173.0
(10.26)
|
173.3
(10.14)
|
| Weight (kg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg] |
79
(16.32)
|
77.9
(17.56)
|
78.4
(16.94)
|
Outcome Measures
| Title | Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant |
|---|---|
| Description | Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity. |
| Time Frame | 12 months posttransplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| intent-to-treat population |
| Arm/Group Title | CellCept + CNI (Tacrolimus or Cyclosporine) | CellCept + Sirolimus |
|---|---|---|
| Arm/Group Description | CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months | CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months |
| Measure Participants | 124 | 130 |
| Mean (Standard Deviation) [Percent change in GFR (mL/min)] |
1.2
(39.86)
|
19.7
(40.64)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CellCept + CNI (Tacrolimus or Cyclosporine), CellCept + Sirolimus |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0012 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 24.9 | |
| Confidence Interval |
() 95% 14.8 to 35.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant |
|---|---|
| Description | Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity. |
| Time Frame | 6 months posttransplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| intent-to-treat population |
| Arm/Group Title | CellCept + CNI (Tacrolimus or Cyclosporine) | CellCept + Sirolimus |
|---|---|---|
| Arm/Group Description | CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months | CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months |
| Measure Participants | 145 | 148 |
| Mean (Standard Deviation) [Percent change in GFR (mL/min)] |
1.1
(24.39)
|
25.5
(45.82)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CellCept + CNI (Tacrolimus or Cyclosporine), CellCept + Sirolimus |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 25.6 | |
| Confidence Interval |
() 95% 15.7 to 35.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant |
|---|---|
| Description | Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity. |
| Time Frame | 24 months posttransplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| intent-to-treat population |
| Arm/Group Title | CellCept + CNI (Tacrolimus or Cyclosporine) | CellCept + Sirolimus |
|---|---|---|
| Arm/Group Description | CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months | CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months |
| Measure Participants | 124 | 130 |
| Mean (Standard Deviation) [Mean percent change in GFR (mL/min)] |
-8.6
(43.37)
|
13.5
(49.17)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CellCept + CNI (Tacrolimus or Cyclosporine), CellCept + Sirolimus |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0053 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 28.7 | |
| Confidence Interval |
() 95% 13.7 to 43.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Creatinine Clearance |
|---|---|
| Description | Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation |
| Time Frame | 6, 12, and 24 months posttransplantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| intent-to-treat population |
| Arm/Group Title | CellCept + CNI (Tacrolimus or Cyclosporine) | CellCept + Sirolimus |
|---|---|---|
| Arm/Group Description | CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months | CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months |
| Measure Participants | 145 | 148 |
| 6 months |
-1.3
(23.71)
|
18.5
(39.93)
|
| 12 months |
-3.0
(35.86)
|
14.0
(35.16)
|
| 24 months |
-12.8
(41.64)
|
7.9
(44.36)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CellCept + CNI (Tacrolimus or Cyclosporine), CellCept + Sirolimus |
|---|---|---|
| Comments | Statistical analysis for calculated creatinine clearance at 6 months posttransplant | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 21.1 | |
| Confidence Interval |
() 95% 12.5 to 29.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | CellCept + CNI (Tacrolimus or Cyclosporine), CellCept + Sirolimus |
|---|---|---|
| Comments | Statistical analysis for calculated creatinine clearance at 12 months posttransplant | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 18.2 | |
| Confidence Interval |
() 95% 9.9 to 26.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | CellCept + CNI (Tacrolimus or Cyclosporine), CellCept + Sirolimus |
|---|---|---|
| Comments | Statistical analysis for calculated creatinine clearance at 24 months posttransplant | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0006 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 23.6 | |
| Confidence Interval |
() 95% 10.2 to 37.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | CellCept + CNI (Tacrolimus or Cyclosporine) | CellCept + Sirolimus | ||
| Arm/Group Description | CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months | CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months | ||
All Cause Mortality |
||||
| CellCept + CNI (Tacrolimus or Cyclosporine) | CellCept + Sirolimus | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| CellCept + CNI (Tacrolimus or Cyclosporine) | CellCept + Sirolimus | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 65/146 (44.5%) | 67/148 (45.3%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/146 (0.7%) | 4/148 (2.7%) | ||
| Leukopenia | 2/146 (1.4%) | 1/148 (0.7%) | ||
| Febrile Neutropenia | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Neutropenia | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Iron Deficiency Anaemia | 0/146 (0%) | 1/148 (0.7%) | ||
| Cardiac disorders | ||||
| Atrial Fibrillation | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Cardiac Failure Congestive | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Myocardial Infarction | 0/146 (0%) | 2/148 (1.4%) | ||
| Acute Myocardial Infarction | 0/146 (0%) | 1/148 (0.7%) | ||
| Atrial Flutter | 1/146 (0.7%) | 0/148 (0%) | ||
| Cardiac Arrest | 0/146 (0%) | 1/148 (0.7%) | ||
| Mitral Valve Incompetence | 0/146 (0%) | 1/148 (0.7%) | ||
| Ventricular Tachycardia | 1/146 (0.7%) | 0/148 (0%) | ||
| Endocrine disorders | ||||
| Inappropriate Antidiuretic Hormone Secretion | 1/146 (0.7%) | 0/148 (0%) | ||
| Eye disorders | ||||
| Cataract | 0/146 (0%) | 1/148 (0.7%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 2/146 (1.4%) | 3/148 (2%) | ||
| Abdominal Pain Upper | 0/146 (0%) | 2/148 (1.4%) | ||
| Gastrointestinal Haemorrhage | 2/146 (1.4%) | 0/148 (0%) | ||
| Mouth Ulceration | 0/146 (0%) | 2/148 (1.4%) | ||
| Peritonitis | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Umbilical Hernia | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Abdominal Hernia | 1/146 (0.7%) | 0/148 (0%) | ||
| Colitis | 0/146 (0%) | 1/148 (0.7%) | ||
| Crohn's Disease | 1/146 (0.7%) | 0/148 (0%) | ||
| Duodenitis Haemorrhagic | 0/146 (0%) | 1/148 (0.7%) | ||
| Gastritis | 1/146 (0.7%) | 0/148 (0%) | ||
| Ileus | 0/146 (0%) | 1/148 (0.7%) | ||
| Inguinal Hernia | 1/146 (0.7%) | 0/148 (0%) | ||
| Inguinal Hernia, Obstructive | 0/146 (0%) | 1/148 (0.7%) | ||
| Intestinal Obstruction | 0/146 (0%) | 1/148 (0.7%) | ||
| Pancreatitis | 0/146 (0%) | 1/148 (0.7%) | ||
| Rectal Ulcer Haemorrhage | 0/146 (0%) | 1/148 (0.7%) | ||
| Small Intestinal Obstruction | 0/146 (0%) | 1/148 (0.7%) | ||
| General disorders | ||||
| Pyrexia | 1/146 (0.7%) | 7/148 (4.7%) | ||
| Chest Pain | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Multi-Organ Failure | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Fat Tissue Increased | 0/146 (0%) | 1/148 (0.7%) | ||
| Fatigue | 1/146 (0.7%) | 0/148 (0%) | ||
| Hernia | 0/146 (0%) | 1/148 (0.7%) | ||
| Hernia Obstructive | 0/146 (0%) | 1/148 (0.7%) | ||
| Impaired Healing | 0/146 (0%) | 1/148 (0.7%) | ||
| Malaise | 1/146 (0.7%) | 0/148 (0%) | ||
| Ulcer Haemorrhage | 0/146 (0%) | 1/148 (0.7%) | ||
| Hepatobiliary disorders | ||||
| Cholangitis | 0/146 (0%) | 4/148 (2.7%) | ||
| Bile Duct Obstruction | 2/146 (1.4%) | 0/148 (0%) | ||
| Bile Duct Stenosis | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Biliary Tract Disorder | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Hepatic Artery Thrombosis | 0/146 (0%) | 2/148 (1.4%) | ||
| Autoimmune Hepatitis | 1/146 (0.7%) | 0/148 (0%) | ||
| Cholestasis | 1/146 (0.7%) | 0/148 (0%) | ||
| Haemobilia | 0/146 (0%) | 1/148 (0.7%) | ||
| Hepatic Artery Stenosis | 1/146 (0.7%) | 0/148 (0%) | ||
| Hepatic Failure | 1/146 (0.7%) | 0/148 (0%) | ||
| Hepatic Function Abnormal | 1/146 (0.7%) | 0/148 (0%) | ||
| Hepatic Infarction | 0/146 (0%) | 1/148 (0.7%) | ||
| Hepatitis Acute | 0/146 (0%) | 1/148 (0.7%) | ||
| Perforation Bile Duct | 0/146 (0%) | 1/148 (0.7%) | ||
| Portal Vein Thrombosis | 1/146 (0.7%) | 0/148 (0%) | ||
| Immune system disorders | ||||
| Transplant Rejection | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Graft Versus Host Disease | 1/146 (0.7%) | 0/148 (0%) | ||
| Hypersensitivity | 0/146 (0%) | 1/148 (0.7%) | ||
| Liver Transplant Rejection | 0/146 (0%) | 1/148 (0.7%) | ||
| Infections and infestations | ||||
| Hepatitis C | 10/146 (6.8%) | 8/148 (5.4%) | ||
| Pneumonia | 3/146 (2.1%) | 2/148 (1.4%) | ||
| Sepsis | 3/146 (2.1%) | 2/148 (1.4%) | ||
| Clostridium Difficile Colitis | 1/146 (0.7%) | 3/148 (2%) | ||
| Viral Infection | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Abdominal Wall Infection | 0/146 (0%) | 1/148 (0.7%) | ||
| Acarodermatitis | 1/146 (0.7%) | 0/148 (0%) | ||
| Appendicitis | 0/146 (0%) | 1/148 (0.7%) | ||
| Bacteraemia | 1/146 (0.7%) | 0/148 (0%) | ||
| Cellulitis | 1/146 (0.7%) | 0/148 (0%) | ||
| Clostridial Infection | 1/146 (0.7%) | 0/148 (0%) | ||
| Diverticulitis | 1/146 (0.7%) | 0/148 (0%) | ||
| Escherichia Urinary Tract Infection | 1/146 (0.7%) | 0/148 (0%) | ||
| Influenza | 1/146 (0.7%) | 0/148 (0%) | ||
| Lactobacillus Infection | 1/146 (0.7%) | 0/148 (0%) | ||
| Liver Abscess | 0/146 (0%) | 1/148 (0.7%) | ||
| Lobar Pneumonia | 1/146 (0.7%) | 0/148 (0%) | ||
| Pseudomonal Sepsis | 1/146 (0.7%) | 0/148 (0%) | ||
| Respiratory Tract Infection | 0/146 (0%) | 1/148 (0.7%) | ||
| Sinusitis | 0/146 (0%) | 1/148 (0.7%) | ||
| Staphylococcal Infection | 1/146 (0.7%) | 0/148 (0%) | ||
| Subcutaneous Abscess | 0/146 (0%) | 1/148 (0.7%) | ||
| Upper Respiratory Tract Infection | 0/146 (0%) | 1/148 (0.7%) | ||
| Urinary Tract Infection | 0/146 (0%) | 1/148 (0.7%) | ||
| Wound Infection | 0/146 (0%) | 1/148 (0.7%) | ||
| Injury, poisoning and procedural complications | ||||
| Incisional Hernia | 4/146 (2.7%) | 4/148 (2.7%) | ||
| Anastomotic Stenosis | 0/146 (0%) | 2/148 (1.4%) | ||
| Post Procedural Haemorrhage | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Procedural Pain | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Biliary Anastomosis Complication | 1/146 (0.7%) | 0/148 (0%) | ||
| Complications of Transplanted Kidney | 1/146 (0.7%) | 0/148 (0%) | ||
| Foot Fracture | 0/146 (0%) | 1/148 (0.7%) | ||
| Graft Loss | 0/146 (0%) | 1/148 (0.7%) | ||
| Meniscus Lesion | 0/146 (0%) | 1/148 (0.7%) | ||
| Post Procedural Haematoma | 0/146 (0%) | 1/148 (0.7%) | ||
| Rib Fracture | 0/146 (0%) | 1/148 (0.7%) | ||
| Stress Fracture | 0/146 (0%) | 1/148 (0.7%) | ||
| Vascular Pseudoaneurysm | 0/146 (0%) | 1/148 (0.7%) | ||
| Investigations | ||||
| Hepatic Enzyme Increased | 0/146 (0%) | 2/148 (1.4%) | ||
| Blood Alkaline Phosphatase Increased | 1/146 (0.7%) | 0/148 (0%) | ||
| Blood Creatinine Increased | 1/146 (0.7%) | 0/148 (0%) | ||
| Blood Glucose Increased | 1/146 (0.7%) | 0/148 (0%) | ||
| Liver Function Test Abnormal | 1/146 (0.7%) | 0/148 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Hyperkalaemia | 4/146 (2.7%) | 0/148 (0%) | ||
| Hyperglycaemia | 2/146 (1.4%) | 0/148 (0%) | ||
| Diabetes Mellitus | 0/146 (0%) | 1/148 (0.7%) | ||
| Hypoglycaemia | 1/146 (0.7%) | 0/148 (0%) | ||
| Hyponatraemia | 1/146 (0.7%) | 0/148 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back Pain | 2/146 (1.4%) | 0/148 (0%) | ||
| Arthralgia | 0/146 (0%) | 1/148 (0.7%) | ||
| Musculoskeletal Pain | 0/146 (0%) | 1/148 (0.7%) | ||
| Pain in Extremity | 0/146 (0%) | 1/148 (0.7%) | ||
| Spinal Osteoarthritis | 1/146 (0.7%) | 0/148 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Hepatic Cancer Metastatic | 2/146 (1.4%) | 3/148 (2%) | ||
| Adenocarcinoma | 1/146 (0.7%) | 0/148 (0%) | ||
| B-Cell Lymphoma | 1/146 (0.7%) | 0/148 (0%) | ||
| Desmoid Tumour | 1/146 (0.7%) | 0/148 (0%) | ||
| Epstein-Barr Virus Associated Lymphoproliferative Disorder | 1/146 (0.7%) | 0/148 (0%) | ||
| Gastrointestinal Tract Adenoma | 1/146 (0.7%) | 0/148 (0%) | ||
| Hepatic Neoplasm Malignant | 1/146 (0.7%) | 0/148 (0%) | ||
| Non-Small Cell Lung Cancer Metastatic | 1/146 (0.7%) | 0/148 (0%) | ||
| Renal Cell Carcinoma | 0/146 (0%) | 1/148 (0.7%) | ||
| Nervous system disorders | ||||
| Headache | 2/146 (1.4%) | 1/148 (0.7%) | ||
| Cerebral Haemorrhage | 1/146 (0.7%) | 0/148 (0%) | ||
| Convulsion | 1/146 (0.7%) | 0/148 (0%) | ||
| Encephalopathy | 1/146 (0.7%) | 0/148 (0%) | ||
| Haemorrhage Intracranial | 1/146 (0.7%) | 0/148 (0%) | ||
| Neuralgic Amyotrophy | 0/146 (0%) | 1/148 (0.7%) | ||
| Neuroleptic Malignant Syndrome | 0/146 (0%) | 1/148 (0.7%) | ||
| Psychiatric disorders | ||||
| Alcohol Abuse | 0/146 (0%) | 1/148 (0.7%) | ||
| Confusional State | 1/146 (0.7%) | 0/148 (0%) | ||
| Renal and urinary disorders | ||||
| Renal Failure | 5/146 (3.4%) | 0/148 (0%) | ||
| Renal Failure Acute | 2/146 (1.4%) | 0/148 (0%) | ||
| Urinary Retention | 1/146 (0.7%) | 0/148 (0%) | ||
| Reproductive system and breast disorders | ||||
| Ovarian Cyst | 0/146 (0%) | 2/148 (1.4%) | ||
| Benign Prostatic Hyperplasia | 1/146 (0.7%) | 0/148 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Pleural Effusion | 4/146 (2.7%) | 0/148 (0%) | ||
| Pulmonary Embolism | 1/146 (0.7%) | 1/148 (0.7%) | ||
| Alveolitis Allergic | 0/146 (0%) | 1/148 (0.7%) | ||
| Dyspnoea | 0/146 (0%) | 1/148 (0.7%) | ||
| Lung Disorder | 1/146 (0.7%) | 0/148 (0%) | ||
| Pulmonary Oedema | 1/146 (0.7%) | 0/148 (0%) | ||
| Sinus Congestion | 1/146 (0.7%) | 0/148 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Drug Eruption | 0/146 (0%) | 1/148 (0.7%) | ||
| Rash | 0/146 (0%) | 1/148 (0.7%) | ||
| Vascular disorders | ||||
| Deep Vein Thrombosis | 2/146 (1.4%) | 4/148 (2.7%) | ||
| Embolism Venous | 1/146 (0.7%) | 0/148 (0%) | ||
| Hypertension | 0/146 (0%) | 1/148 (0.7%) | ||
| Orthostatic Hypotension | 1/146 (0.7%) | 0/148 (0%) | ||
| Vasculitis | 1/146 (0.7%) | 0/148 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| CellCept + CNI (Tacrolimus or Cyclosporine) | CellCept + Sirolimus | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 134/146 (91.8%) | 141/148 (95.3%) | ||
| Blood and lymphatic system disorders | ||||
| Leukopenia | 21/146 (14.4%) | 35/148 (23.6%) | ||
| Anaemia | 14/146 (9.6%) | 13/148 (8.8%) | ||
| Neutropenia | 11/146 (7.5%) | 7/148 (4.7%) | ||
| Thrombocytopenia | 5/146 (3.4%) | 7/148 (4.7%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 42/146 (28.8%) | 37/148 (25%) | ||
| Abdominal Pain | 26/146 (17.8%) | 21/148 (14.2%) | ||
| Nausea | 23/146 (15.8%) | 19/148 (12.8%) | ||
| Vomiting | 20/146 (13.7%) | 12/148 (8.1%) | ||
| Abdominal Pain Upper | 11/146 (7.5%) | 7/148 (4.7%) | ||
| Constipation | 10/146 (6.8%) | 6/148 (4.1%) | ||
| Mouth Ulceration | 0/146 (0%) | 10/148 (6.8%) | ||
| Stomatitis | 1/146 (0.7%) | 9/148 (6.1%) | ||
| General disorders | ||||
| Pyrexia | 21/146 (14.4%) | 25/148 (16.9%) | ||
| Fatigue | 23/146 (15.8%) | 26/148 (17.6%) | ||
| Oedema Peripheral | 17/146 (11.6%) | 27/148 (18.2%) | ||
| Asthenia | 7/146 (4.8%) | 8/148 (5.4%) | ||
| Hepatobiliary disorders | ||||
| Jaundice | 7/146 (4.8%) | 2/148 (1.4%) | ||
| Infections and infestations | ||||
| Hepatitis C | 23/146 (15.8%) | 20/148 (13.5%) | ||
| Upper Respiratory Tract Infection | 8/146 (5.5%) | 7/148 (4.7%) | ||
| Sinusitis | 10/146 (6.8%) | 4/148 (2.7%) | ||
| Nasopharyngitis | 7/146 (4.8%) | 5/148 (3.4%) | ||
| Injury, poisoning and procedural complications | ||||
| Incisional Hernia | 3/146 (2.1%) | 9/148 (6.1%) | ||
| Incision Site Pain | 7/146 (4.8%) | 8/148 (5.4%) | ||
| Investigations | ||||
| Hepatic Enzyme Increased | 11/146 (7.5%) | 12/148 (8.1%) | ||
| Liver Function Test Abnormal | 9/146 (6.2%) | 12/148 (8.1%) | ||
| Weight Increased | 8/146 (5.5%) | 9/148 (6.1%) | ||
| Weight Decreased | 10/146 (6.8%) | 5/148 (3.4%) | ||
| White Blood Cell Count Decreased | 9/146 (6.2%) | 5/148 (3.4%) | ||
| Blood Creatinine Increased | 9/146 (6.2%) | 0/148 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Hyperlipidaemia | 5/146 (3.4%) | 15/148 (10.1%) | ||
| Hyperkalaemia | 14/146 (9.6%) | 2/148 (1.4%) | ||
| Anorexia | 6/146 (4.1%) | 8/148 (5.4%) | ||
| Hypercholesterolaemia | 2/146 (1.4%) | 10/148 (6.8%) | ||
| Decreased Appetite | 8/146 (5.5%) | 3/148 (2%) | ||
| Hypokalaemia | 3/146 (2.1%) | 7/148 (4.7%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 13/146 (8.9%) | 14/148 (9.5%) | ||
| Back Pain | 15/146 (10.3%) | 11/148 (7.4%) | ||
| Pain in Extremity | 12/146 (8.2%) | 9/148 (6.1%) | ||
| Muscle Spasms | 7/146 (4.8%) | 7/148 (4.7%) | ||
| Myalgia | 4/146 (2.7%) | 8/148 (5.4%) | ||
| Nervous system disorders | ||||
| Headache | 24/146 (16.4%) | 38/148 (25.7%) | ||
| Tremor | 15/146 (10.3%) | 12/148 (8.1%) | ||
| Dizziness | 11/146 (7.5%) | 8/148 (5.4%) | ||
| Psychiatric disorders | ||||
| Insomnia | 16/146 (11%) | 13/148 (8.8%) | ||
| Depression | 8/146 (5.5%) | 10/148 (6.8%) | ||
| Renal and urinary disorders | ||||
| Renal Failure | 7/146 (4.8%) | 2/148 (1.4%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 13/146 (8.9%) | 13/148 (8.8%) | ||
| Dyspnoea | 10/146 (6.8%) | 9/148 (6.1%) | ||
| Oropharyngeal Pain | 6/146 (4.1%) | 11/148 (7.4%) | ||
| Rhinorrhoea | 6/146 (4.1%) | 7/148 (4.7%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 5/146 (3.4%) | 26/148 (17.6%) | ||
| Pruritis | 13/146 (8.9%) | 8/148 (5.4%) | ||
| Night Sweats | 6/146 (4.1%) | 11/148 (7.4%) | ||
| Acne | 4/146 (2.7%) | 7/148 (4.7%) | ||
| Vascular disorders | ||||
| Hypertension | 15/146 (10.3%) | 16/148 (10.8%) | ||
Limitations/Caveats
There were no overall limitations and caveats.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | 800-821-8590 |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00118742
Other Study ID Numbers:
- ML18423
First Posted:
Jul 12, 2005
Last Update Posted:
Aug 3, 2010
Last Verified:
Jul 1, 2010