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To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation when converted from cyclosporine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | patients with kidney transplantation who converted the immunosuppressant from cyclosporine to Graceptor ® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Graceptor® | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of treatment continuation (incidence of rejection, death, graft loss, or adverse event) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function, hypertension, hyperlipidaemia, other adverse events | 12 months |
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Inclusion Criteria:
Patients who are converted to Graceptor® from cyclosporine in the maintenance phase after kidney transplantation.
Patients who meet one or more of following criteria
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Patients who are converted to Graceptor® from cyclosporine in the maintenance phase after kidney transplantation.
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site JP00010 | Numakunai | Iwate | Japan | |||
| Site JP00001 |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| Aichi |
| Japan |
| Site JP00015 | Chiba | Japan |
| Site JP00003 | Ehime | Japan |
| Site JP00029 | Fukuoka | Japan |
| Site JP00009 | Fukushima | Japan |
| Site JP00017 | Gifu | Japan |
| Site JP00002 | Hiroshima | Japan |
| Site JP00005 | Hokkaido | Japan |
| Site JP00024 | Hyōgo | Japan |
| Site JP00012 | Ibaraki | Japan |
| Site JP00020 | Ishikawa | Japan |
| Site JP00026 | Kagawa | Japan |
| Site JP00030 | Kagoshima | Japan |
| Site JP00014 | Kanagawa | Japan |
| Site JP00027 | Kochi | Japan |
| Site JP00028 | Kumamoto | Japan |
| Site JP00008 | Kyoto | Japan |
| Site JP00019 | Mie | Japan |
| Site JP00011 | Miyagi | Japan |
| Site JP00006 | Nagasaki | Japan |
| Site JP00023 | Nara | Japan |
| Site JP00013 | Niigata | Japan |
| Site JP00025 | Okayama | Japan |
| Site JP00022 | Osaka | Japan |
| Site JP00016 | Saitama | Japan |
| Site JP00018 | Shizuoka | Japan |
| Site JP00007 | Tokyo | Japan |
| Site JP00021 | Wakayama | Japan |
| Site JP00004 | Yamagata | Japan |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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