Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants. Patients currently receiving CNI treatment will be randomized into one of 2 groups to receive either 1) CellCept 2.0g/day po bid + 50% reduction of CNI from baseline or 2) CellCept 2.0g/day po bid + >=75% reduction of CNI from baseline. The anticipated time on study treatment is 1 year, and the target sample size is <100 individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMF, 50% CNI Reduction | Experimental | Participants received mycophenolate mofetil (MMF), 1.5 to 2.0 grams (g) daily, orally (PO), twice per day (BID) from baseline (BL) to Week 52. Participants also received a 50 percent (%) reduced dose of calcineurin inhibitor (CNI) from BL to Week 52. |
|
| MMF, ≥75% CNI Reduction | Experimental | Participants received MMF, 1.5 to 2.0 g daily, PO, BID from BL to Week 52. Participants also received a 75% reduced dose of CNI from BL to Week 52. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate mofetil | Drug | 1.5 to 2.0 g daily PO BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20% | The percentage of participants with a greater than 20% decrease of GFR during the 1-year period following regimen adjustment. Cockcroft and Gault formula was used for calculated creatinine clearance. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Graft Loss or Death at Week 52 | Graft loss was defined for this protocol as re-transplantion or death. | Week 52 |
| Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | 100039 | China | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mycophenolate Mofetil (MMF), 50% Calcineurin Inhibitor (CNI) | Participants received MMF capsules, 1.5 to 2.0 grams (g), orally (PO), twice daily (BID) up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50 percent (%) through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CNI (50%) | Drug | 50% reduction from BL |
|
| CNI (≥75%) | Drug | ≥75% reduction from BL |
|
BPAR was graded according to Banff criteria.
| Week 52 |
| Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min]) | Creatinine clearance calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min equaled (=) [(140 minus (-) age in years) multiplied by (*) (weight in kilograms (kg)] divided by [72 * serum creatinine in milligrams per deciliter (mg/dL)]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL). | Baseline and Weeks 16, 28, and 40 |
| Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52 | Corrected creatinine clearance was calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min = [(140 - age in years) * (weight in kg] divided by [72 * serum creatinine in mg/dL]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL). | Week 52 |
| Percentage Change in Creatinine Clearance From Baseline | Creatinine clearance was calculated using the Cockcroft and Gault formula. | Weeks 16, 28, 40, and 52 |
| Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52 | The percentage of participants who experienced at least 1 of the following: a ≥20% decrease from BL in creatinine clearance, acute rejection, graft loss, or death 1 year after randomization. | Week 52 |
| Beijing |
| 100054 |
| China |
| Changsha | 410013 | China |
| Chengdu | 610041 | China |
| Chongqing | 400038 | China |
| Guangzhou | 510080 | China |
| Jiangsu | 210029 | China |
| Shanghai | 200003 | China |
| Shanghai | 200080 | China |
| Tianjin | 300192 | China |
| Xi'an | 710032 | China |
| FG001 | MMF, 75% CNI | Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Per-Protocol (PP) population: all participants who received at least 1 dose of the treatment-group specific medication who did not dropout from the study prematurely.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MMF, 50% CNI | Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant. |
| BG001 | MMF, 75% CNI | Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | PP population included all participants completing study treatment, n= 37 and 34 participants in the MMF, 50% CNI Reduction and MMF, ≥75% CNI Reduction groups, respectively. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20% | The percentage of participants with a greater than 20% decrease of GFR during the 1-year period following regimen adjustment. Cockcroft and Gault formula was used for calculated creatinine clearance. | PP population | Number | percentage of participants | Week 52 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Graft Loss or Death at Week 52 | Graft loss was defined for this protocol as re-transplantion or death. | PP population | Number | percentage of participants | Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52 | BPAR was graded according to Banff criteria. | PP population | Number | percentage of participants | Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min]) | Creatinine clearance calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min equaled (=) [(140 minus (-) age in years) multiplied by (*) (weight in kilograms (kg)] divided by [72 * serum creatinine in milligrams per deciliter (mg/dL)]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL). | PP population; number (n) = number of participants assessed for the specified parameter at a given visit. | Mean | Standard Deviation | mL/min | Baseline and Weeks 16, 28, and 40 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52 | Corrected creatinine clearance was calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min = [(140 - age in years) * (weight in kg] divided by [72 * serum creatinine in mg/dL]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL). | PP population; number (n) = number of participants assessed for the specified parameter at a given visit. | Mean | 95% Confidence Interval | mL/min | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change in Creatinine Clearance From Baseline | Creatinine clearance was calculated using the Cockcroft and Gault formula. | PP population | Mean | Standard Deviation | percentage change from baseline | Weeks 16, 28, 40, and 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52 | The percentage of participants who experienced at least 1 of the following: a ≥20% decrease from BL in creatinine clearance, acute rejection, graft loss, or death 1 year after randomization. | PP population | Number | percentage of participants | Week 52 |
|
Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MMF, 50% CNI | Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant. | 1 | 43 | 15 | 43 | ||
| EG001 | MMF, 75% CNI | Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant. | 3 | 40 | 15 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Acute rejection | Immune system disorders | Non-systematic Assessment |
| ||
| Biliiary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Recurrent hepatitis B virus | Infections and infestations | Non-systematic Assessment |
| ||
| Hepatic cancer bladder metastasis | Nervous system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Non-systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Non-systematic Assessment |
| ||
| Blood urine present | Investigations | Non-systematic Assessment |
| ||
| Blood glucose increased | Investigations | Non-systematic Assessment |
| ||
| Gamma-glutamytransferase increased | Investigations | Non-systematic Assessment |
| ||
| Glucose urine present | Investigations | Non-systematic Assessment |
| ||
| Neutrophil cound decreased | Investigations | Non-systematic Assessment |
| ||
| Red blood cell count decreased | Investigations | Non-systematic Assessment |
| ||
| Weight decreased | Investigations | Non-systematic Assessment |
| ||
| Urine leukocyte esterase positive | Investigations | Non-systematic Assessment |
| ||
| Protein urine present | Investigations | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Lung infection | Infections and infestations | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Mouth ulceration | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hyperbilirubinaemia | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Perihepatic discomfort | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Transplant rejection | Immune system disorders | Non-systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Renal injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Asthenia | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Hypercholesterolaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| C485557 | cni protein, Drosophila |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|