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Sponsor decision to terminate the study because subject enrollment was difficult.
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The objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus group | Experimental | oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | Oral |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in GFR | GFR: glomerular filtration rate | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total cholesterol | Baseline and Week 24 | |
| Change from baseline in Triglycerides | Baseline and Week 24 | |
| Change from baseline in LDL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Korea, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KR00001 | Seoul | Seoul | South Korea |
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LDL: low density lipoprotein cholesterol |
| Baseline and Week 24 |
| Change from baseline in HDL | HDL: high density lipoprotein cholesterol | Baseline and Week 24 |
| Change from baseline in the number of antihyperlipidemic drugs | Baseline and Week 24 |
| Change from baseline in blood pressure | Baseline and Week 24 |
| Change from baseline in the number of antihypertensive drugs | Baseline and Week 24 |
| Change from baseline in number of participants who have had hirsutism | Investigator's judgment | Baseline and Week 24 |
| Change from baseline in number of participants who have had gingival hypertrophy | Investigator's judgment | Baseline and Week 24 |
| Overall incidence rate of adverse events | up to Week 24 |
| Proportion of participants with patient survival | up to Week 24 |
| Proportion of participants with organ survival | up to Week 24 |
| Acute rejection rate confirmed by biopsy | up to Week 24 |
| Ratio of mean dose of cyclosporine to tacrolimus | up to Week 24 |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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