JRCT ID: jRCT2031210549
Registered date:07/01/2022
Special use-results survey of ENAROY Tablets (long-term use)
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Anemia associated with CKD |
Date of first enrollment | 04/03/2022 |
Target sample size | 1500 |
Countries of recruitment | |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | -Incidence of onset of thromboembolism -Incidence of onset of hypertension -Incidence of cardiovascular events (excluding thromboembolism) -Incidence of onset of retinal hemorrhage -Incidence of onset of malignant tumor -Incidence of progressed disease in patients with autosomal dominant polycystic kidney disease (ADPKD) |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | (1) Patients using Enaroy for the first time for nephrogenic anemia (2) Patients must provide informed consent before the start |
Exclude criteria | none |
Related Information
Primary Sponsor | Patient Safety and Pharmacovigilance Dept. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Patient Safety and Pharmacovigilance Dept. |
Address | 3-4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo, Japan Tokyo Japan 103-0023 |
Telephone | +81-3-6635-3504 |
pms-pharma@jt.com | |
Affiliation | Japan Tobacco Inc. |
Scientific contact | |
Name | Patient Safety and Pharmacovigilance Dept. |
Address | 3-4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo, Japan Tokyo Japan 103-0023 |
Telephone | +81-3-6635-3504 |
pms-pharma@jt.com | |
Affiliation | Japan Tobacco Inc. |