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The objective of this study is to evaluate the effects of tacrolimus sustained-release capsules replacing cyclosporin on kidney function of renal transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus sustained-release capsule group | Experimental | Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus sustained-release capsule | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in creatinine level | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in creatinine level | Baseline and Weeks 1, 2, 4, 8 and 12 | |
| Incidence of rejection reaction after drug use | Up to Week 24 | |
| Plasma concentrations of tacrolimus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
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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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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Weeks 1, 2, 4, 8, 12 and 24 |
| Change from baseline in blood pressure | Diastolic pressure and systolic pressure | Baseline and Weeks 1, 2, 4, 8, 12 and 24 |
| Change from baseline in blood lipid | Total cholesterol, high density lipoprotein, low density lipoprotein, triglyceride | Baseline and Weeks 1, 2, 4, 8, 12 and 24 |
| Change from baseline in liver function | Aspartate aminotransferase, alanine aminotransferase, bilirubin | Baseline and Weeks 1, 2, 4, 8, 12 and 24 |
| Change from baseline in fasting blood glucose | Baseline and Weeks 1, 2, 4, 8, 12 and 24 |
| Change from baseline in gingival hyperplasia | Baseline and Week 24 |
| Change from baseline in polytrichia | Baseline and Week 24 |
| Safety assessed by Adverse Events | Up to 24 weeks |
| Changchun |
| China |
| Chengdu | China |
| Guangzhou | China |
| Nanjing | China |
| Nanning | China |
| Shanghai | China |
| Shenyang | China |
| Wuhan | China |