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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012355-15 |
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This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based therapy. On the study day patients will take their prescribed medication (either CellCept or mycophenolate sodium). Blood samples will be drawn directly before and at intervals up to 12 hours after intake of the study medication. Anticipated time on study treatment is 12 hours and target sample size is 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMF, Prednisone | Experimental | Participants received mycophenolate mofetil (MMF) orally (PO) at a dose of 1 gram per day (g/day) twice daily (BID), and prednisone, PO, up to 5 milligrams per day (mg/day) for at least 1 month. |
|
| EC-MPS | Active Comparator | Participants received mycophenolate sodium (EC-MPS), PO, at a dose of 720 mg/day BID, and prednisone PO up to 5 mg/day for at least 1 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMF | Drug | 1 g per day b.i.d. p.o. for at least 1 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-dose Trough Concentration (C0) | The mean mycophenolic acid (MPA) concentration in plasma was determined (in milligrams per liter [mg/L]) from blood samples collected predose (immediately before receiving study treatment). | Day 1 predose |
| Dose-Normalized C0 | Dose normalized C0 was determined (in mg/L) from blood samples collected predose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows: For the MMF group: Dose normalized C0 equals (=) C0 divided by (/) (actual dose taken/1000) For the EC-MPS group: Dose normalized C0 = C0 / (actual dose taken/720) | Day 1 predose |
| Minimum Plasma Concentration (Cmin) | The mean minimum MPA concentration in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
| Dose-Normalized Cmin | Dose-normalized Cmin was determined (in mg/L) from blood samples collected predose and postdose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows: For the MMF group: Dose normalized Cmin = Cmin/ (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmin = Cmin / (actual dose taken/720) | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
| Maximum Plasma Concentration (Cmax) | The mean maximum MPA concentration in plasma was determined (in mg/L) in blood samples collected predose and postdose on Day 1. | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Regression Coefficients For Participants Receiving MMF | The estimated regression coefficients for participants who received MMF presented in milligrams per liter (mg/L). | Day 1 at 30 minutes and 1 and 2 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frankfurt am Main | 60528 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mycophenolate Mofetil (MMF)/Prednisone | Participants were administered MMF tablets or capsules, orally (PO), at a dose prescribed by their physician and prednisone up to 5 milligrams (mg) PO on Day 1. |
| FG001 | Enteric-coated Mycophenolate Sodium (EC-MPS)/Prednisone | Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The pharmacokinetic (PK) population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | MMF/Prednisone | Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1. |
| BG001 | EC-MPS/Prednisone |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pre-dose Trough Concentration (C0) | The mean mycophenolic acid (MPA) concentration in plasma was determined (in milligrams per liter [mg/L]) from blood samples collected predose (immediately before receiving study treatment). | Pharmacokinetic (PK) population: all participants who took study drug and for whom all defined blood samples at the planned sampling time points were available. | Posted | Mean | Standard Deviation | mg/L | Day 1 predose |
|
The observational period, approximately 13 hours.
All randomized participants were included in the safety analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MMF/Prednisone | Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| EC-MPS | Drug | 720 mg b.i.d. p.o. for at least 1 month |
|
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| Prednisone | Drug | 5 mg per day p.o. |
|
| Dose-Normalized Cmax (mg/L) | Dose-normalized Cmax in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows: For the MMF group: Dose normalized Cmax = Cmax / (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmax = Cmax / (actual dose taken/720) | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
| MPA Area Under the Curve From 0 to 12 Hours (AUC0-12) | The mean MPA AUC0-12 in plasma was determined (in mg multiplied by hours, per Liter [mg*h/L]) from blood samples collected predose and postdose on Day 1. | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
| Dose-Normalized MPA AUC0-12 | Dose-normalized MPA AUC0-12 in plasma was determined (mg*h/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows: For the MMF group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/1000) For the EC-MPS group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/720) | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
| Percentage of Participants By Time to Maximum Plasma Concentration (Tmax) | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
|
|
|
| Primary | Dose-Normalized C0 | Dose normalized C0 was determined (in mg/L) from blood samples collected predose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows: For the MMF group: Dose normalized C0 equals (=) C0 divided by (/) (actual dose taken/1000) For the EC-MPS group: Dose normalized C0 = C0 / (actual dose taken/720) | PK population | Posted | Mean | Standard Deviation | mg/L | Day 1 predose |
|
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|
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| Primary | Minimum Plasma Concentration (Cmin) | The mean minimum MPA concentration in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. | PK population | Posted | Mean | Standard Deviation | mg/L | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
|
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|
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| Primary | Dose-Normalized Cmin | Dose-normalized Cmin was determined (in mg/L) from blood samples collected predose and postdose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows: For the MMF group: Dose normalized Cmin = Cmin/ (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmin = Cmin / (actual dose taken/720) | PK population | Posted | Mean | Standard Deviation | mg/L | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
|
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| Primary | Maximum Plasma Concentration (Cmax) | The mean maximum MPA concentration in plasma was determined (in mg/L) in blood samples collected predose and postdose on Day 1. | PK population | Posted | Mean | Standard Deviation | mg/L | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
|
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| Primary | Dose-Normalized Cmax (mg/L) | Dose-normalized Cmax in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows: For the MMF group: Dose normalized Cmax = Cmax / (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmax = Cmax / (actual dose taken/720) | PK population | Posted | Mean | Standard Deviation | mg/L | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
|
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|
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| Primary | MPA Area Under the Curve From 0 to 12 Hours (AUC0-12) | The mean MPA AUC0-12 in plasma was determined (in mg multiplied by hours, per Liter [mg*h/L]) from blood samples collected predose and postdose on Day 1. | PK population | Posted | Mean | Standard Deviation | mg*h/L | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
|
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| Primary | Dose-Normalized MPA AUC0-12 | Dose-normalized MPA AUC0-12 in plasma was determined (mg*h/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows: For the MMF group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/1000) For the EC-MPS group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/720) | PK population | Posted | Mean | Standard Deviation | mg*h/L | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
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| Primary | Percentage of Participants By Time to Maximum Plasma Concentration (Tmax) | PK population | Posted | Number | percentage of participants | Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours |
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| Secondary | Regression Coefficients For Participants Receiving MMF | The estimated regression coefficients for participants who received MMF presented in milligrams per liter (mg/L). | PK population. Only participants in the MMF/Prednisone group were assessed for this outcome measure, n=12. | Posted | Number | mg/L | Day 1 at 30 minutes and 1 and 2 hours postdose |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | EC-MPS/Prednisone | Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1. | 0 | 11 | 0 | 11 |
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.
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Tmax=0.7333 hrs |
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| Tmax=0.7667 hrs |
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| Tmax=1.0667 hrs |
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| Tmax=1.0833 hrs |
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| Tmax=1.1167 hrs |
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| Tmax=1.2167 hrs |
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| Tmax=2.0167 hrs |
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| Tmax=2.0833 hrs |
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| Tmax=2.1000 hrs |
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| Tmax=2.1167 hrs |
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| Tmax=2.1667 hrs |
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| Tmax=3.1167 hrs |
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| Tmax=3.1833 hrs |
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| Title | Measurements |
|---|---|
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| Concentration at 2 hours (C2) |
|