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To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.
The objectives of the survey are to evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use situations, and to identify factors that might affect the safety and efficacy of tacrolimus. In addition, long-term renal outcome will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tacrolimus group | Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of renal events (renal failure and progression to dialysis) | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour urinary protein | Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year | |
| Urinary red blood cell (RBC) count | Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year |
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patients receiving tacrolimus for the treatment of lupus nephritis
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patients receiving tacrolimus for the treatment of lupus nephritis
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chūbu | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38359944 | Derived | Takeuchi T, Wakasugi N, Hashida T, Uno S, Makino H. Long-Term Safety and Effectiveness of Tacrolimus in Patients With Lupus Nephritis in Japan: 10-Year Analysis of the Real-World TRUST Study. J Rheumatol. 2024 Jun 1;51(6):613-621. doi: 10.3899/jrheum.2023-0210. | |
| 32238515 | Derived | Takeuchi T, Wakasugi N, Uno S, Makino H. Long-term Safety and Effectiveness of Tacrolimus in Patients With Lupus Nephritis: 5-year Interim Postmarketing Surveillance Study in Japan (TRUST). J Rheumatol. 2021 Jan 1;48(1):74-81. doi: 10.3899/jrheum.191008. Epub 2020 Apr 1. |
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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 |
|---|---|
| D008181 | Lupus Nephritis |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Serum creatinine | Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year |
| Hokkaido |
| Japan |
| Kansai | Japan |
| Kantou | Japan |
| Kyusyu | Japan |
| Shagoku | Japan |
| Shikoku | Japan |
| TÅhoku | Japan |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |