JRCT ID: jRCT2041210113
Registered date:17/12/2021
General drug use-results survey of UPASITA IV Injection Syringe for Dialysis
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Secondary hyperparathyroidism under hemodialysis |
| Date of first enrollment | 20/01/2022 |
| Target sample size | 770 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Incidence of onset of hypocalcaemia Incidence of onset of QT prolonged Incidence of onset of bone metabolism disorder |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | Patients with secondary hyperparathyroidism under hemodialysis who are using this drug for the first time |
| Exclude criteria | None |
Related Information
| Primary Sponsor | Dept. Pharmacovigilance |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Pharmacovigilance Dept. |
| Address | 35,Higashisotoboricho, Higashi-ku,Nagoya, Aichi Aichi Japan 461-8631 |
| Telephone | +81-52-951-8167 |
| pms@ml.skk-net.com | |
| Affiliation | Sanwa Kagaku Kenkyusho Co., Ltd. |
| Scientific contact | |
| Name | Pharmacovigilance Dept. |
| Address | 35,Higashisotoboricho, Higashi-ku,Nagoya, Aichi Aichi Japan 461-8631 |
| Telephone | +81-52-951-8167 |
| pms@ml.skk-net.com | |
| Affiliation | Sanwa Kagaku Kenkyusho Co., Ltd. |