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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000011559
Date of registration:	01/09/2013
Prospective Registration:	Yes
Primary sponsor:	Department of Urology, Keio University School of Medicine
Public title:	Therpeutic drug monitoring of Everolimus in patients with renal cell carcinoma and tuberous sclerosis
Scientific title:	Therpeutic drug monitoring of Everolimus in patients with renal cell carcinoma and tuberous sclerosis - TDM study of Everolimus
Date of first enrolment:	2013/09/01
Target sample size:	43
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013524
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Ryuichi Mizuno
Address:	35 Shinanomachi, Shinjyuku, Tokyo Japan
Telephone:	03-3353-1211
Email:	mizunor@z7.keio.jp
Affiliation:	Keio University School of Medicine Department of Urology

Name:	Toshiaki Shinojima
Address:	35 Shinanomachi, Shinjyuku, Tokyo Japan
Telephone:	03-3353-1211
Email:	t-shinoj@cd5.so-net.ne.jp
Affiliation:	Keio University School of Medicine Department of Urology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: Pregnancy Interstitial lung marking in chest imaging Infection Liver dysfunction

Age minimum: 20years-old
Age maximum: 90years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

1.advanced renal cell carcinoma 2.renal angiomyolipoma associated with tuberous sclerosis complex

Intervention(s)

Everolimus 5mg/day.

Primary Outcome(s)

Statistical difference of evelolimus trough level between adverse and non-adverse effect

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Japan Research Foundation for Clinical Pharmacology

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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