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
| Name | Class |
|---|---|
| Astellas Pharma Taiwan, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF in de novo kidney transplant recipients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prograf-XL + MMF | Experimental |
| |
| Prograf + MMF | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prograf-XL | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The patient and graft survival rates at 6 month post-transplant | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy failure at 6-month posttransplant. | 6 months | |
| Incidence of biopsy confirmed acute rejection (Banff > 1) at 6 months and 12 months | 6 months and 12 months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung | 407 | Taiwan | ||||
Not provided
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Prograf | Drug | oral |
|
|
| MMF | Drug | oral |
|
|
| 1 year patient and graft survival |
| 1 year |
| Tainan |
| 704 |
| Taiwan |
| Taipei | 100 | Taiwan |
| Taipei | 112 | Taiwan |
| Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided