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
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy of tacrolimus modified release formulation Advagraf® after conversion from Prograf® in stable kidney transplant patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prograf/Advagraf | Experimental | conversion from Prograf to Advagraf |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prograf | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glomerular filtration rate (GFR) at Week 24 from baseline | Baseline and Week-24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure (BP) at Week 24 from baseline | Baseline and Week-24 | |
| Change in HbA1c at Week 24 from baseline | Baseline and Week-24 | |
| Change in tacrolimus blood trough level at Week 24 from baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Korea, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Busan | South Korea | |||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Advagraf | Drug | oral |
|
|
| Baseline and Week-24 |
| Safety assessed by the incidence of adverse events, physical exam., vital signs and labo tests | For 24 weeks |
| Overall frequency of acute rejection | For 24 weeks |
| Daegu |
| South Korea |
| Daejeon | South Korea |
| Seoul | South Korea |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided