the Maintenance Phase After Kidney Transplantation Clinical Trial
Official title:
Specified Drug Use-Results Survey of Graceptor® Capsules 0.5mg, 1 mg, and 5 mg in Kidney Transplant Patients
| NCT number | NCT02160054 |
| Other study ID # | GRA006 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 15, 2013 |
| Est. completion date | March 31, 2016 |
| Verified date | April 2019 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation when converted from cyclosporine
| Status | Completed |
| Enrollment | 289 |
| Est. completion date | March 31, 2016 |
| Est. primary completion date | March 31, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 1. Decrease in kidney function: GFR (or eGFR) less than 60 mL/min, or investigator's decision 2. Hypertension: systolic/diastolic blood pressure 130/80 mmHg or more or treatment with an antihypertensive drug 3. Hyperlipidaemia: LDL cholesterol 120 mg/dL or more, or treatment with an antihyperlipidemic drug 4. Rejection: antibody mediated rejection by Banff classification borderline changes or more severe, or investigator's decision 5. Other adverse events and patients who cannot continue cyclosporine treatment based on investigator's decision |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Site JP00001 | 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 | Hyogo | |
| Japan | Site JP00012 | Ibaraki | |
| Japan | Site JP00020 | Ishikawa | |
| Japan | Site JP00010 | Iwate | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of treatment continuation (incidence of rejection, death, graft loss, or adverse event) | 12 months | ||
| Secondary | Renal function, hypertension, hyperlipidaemia, other adverse events | 12 months |