UMIN ID: UMIN000011559
Registered date:01/09/2013
Therpeutic drug monitoring of Everolimus in patients with renal cell carcinoma and tuberous sclerosis
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | 1.advanced renal cell carcinoma 2.renal angiomyolipoma associated with tuberous sclerosis complex |
| Date of first enrollment | 2013/09/01 |
| Target sample size | 43 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Everolimus 5mg/day. |
Outcome(s)
| Primary Outcome | Statistical difference of evelolimus trough level between adverse and non-adverse effect |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 90years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Pregnancy Interstitial lung marking in chest imaging Infection Liver dysfunction |
Related Information
| Primary Sponsor | Department of Urology, Keio University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Japan Research Foundation for Clinical Pharmacology |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Toshiaki Shinojima |
| Address | 35 Shinanomachi, Shinjyuku, Tokyo Japan |
| Telephone | 03-3353-1211 |
| t-shinoj@cd5.so-net.ne.jp | |
| Affiliation | Keio University School of Medicine Department of Urology |
| scientific contact | |
| Name | Ryuichi Mizuno |
| Address | 35 Shinanomachi, Shinjyuku, Tokyo Japan |
| Telephone | 03-3353-1211 |
| mizunor@z7.keio.jp | |
| Affiliation | Keio University School of Medicine Department of Urology |