Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Patients participating in study ML17225 will be eligible for this pharmacogenetic investigation, and will have one additional blood sample taken during the study. The anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size is 500+ individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mycophenolate mofetil [CellCept] | Drug | Concentration-controlled |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of allelic variants of MPA metabolizing genes, membrane transporter genes and target genes with AUC, transplant rejection, GER and drug side effects. | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Viral kinetics | Throughout study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| mycophenolate mofetil [CellCept] |
| Drug |
1g po bid |
|
| Cyclosporine or tacrolimus | Drug | Reduced |
|
| Cyclosporine or tacrolimus | Drug | Standard, as prescribed |
|
| Little Rock |
| Arkansas |
| 72205-7199 |
| United States |
| Los Angeles | California | 90057 | United States |
| Denver | Colorado | 80262 | United States |
| Gainesville | Florida | 32610-0224 | United States |
| Orlando | Florida | 32804 | United States |
| Augusta | Georgia | 30912 | United States |
| Chicago | Illinois | 60637 | United States |
| Indianapolis | Indiana | 46202-5167 | United States |
| Lexington | Kentucky | 40536-0293 | United States |
| Shreveport | Louisiana | 71130 | United States |
| Boston | Massachusetts | 02111 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Livingston | New Jersey | 07039 | United States |
| Buffalo | New York | 14203 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Fargo | North Dakota | 58122 | United States |
| Portland | Oregon | 97210 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018942 | Macrolides |
| D007783 | Lactones |
Not provided
Not provided