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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019393
Receipt No. R000021979
Scientific Title Consideration the changes of renal function for renal cell carcinoma patients, administered the molecular target drugs: axitinib, sunitinib and sorafenib
Date of disclosure of the study information 2015/10/19
Last modified on 2015/10/19

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Basic information
Public title Consideration the changes of renal function for renal cell carcinoma patients, administered the molecular target drugs: axitinib, sunitinib and sorafenib
Acronym Consideration the changes of renal function for renal cell carcinoma patients, administered the molecular target drugs
Scientific Title Consideration the changes of renal function for renal cell carcinoma patients, administered the molecular target drugs: axitinib, sunitinib and sorafenib
Scientific Title:Acronym Consideration the changes of renal function for renal cell carcinoma patients, administered the molecular target drugs
Region
Japan

Condition
Condition Renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We consider the changes of renal function by administering the molecular target drugs: axitinib, sunitinib or sorafenib, for which the dose is determined for each
Basic objectives2 Others
Basic objectives -Others We consider a therapeutic effect by administering the molecular target drugs: axitinib, sunitinib or sorafenib, for which the dose is determined for each. Therapeutic effect for target lesions is measured by using CT.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes For renal cell carcinoma patients, we evaluate the blood exam containing a renal function 1,2,4 and 12 weeks later from administration of the molecular target drugs whose daily doses are determined by eGFR (axitinib 10mg, sorafenib 800mg, sunitinib 50mg on over 45), (axitinib 6mg, sorafenib 800mg, sunitinib 37.5mg on low by 45).
Key secondary outcomes We consider a therapeutic effect by administering the molecular target drug that is axitinib, sunitinib or sorafenib. Therapeutic effect for target lesions is examined using CT. The time for measuring is before and 4, 12weeks later from administration. For the case with preoperative setting, PET is performed before and after administration.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A daily dose of the molecular target drug, axitinib is determined by eGFR (10mg on over 45, 6mg on low by 45). We evaluate the blood exam containing a renal function 1,2,4 and 12 weeks later from administration of the molecular target drug. And, we evaluate the lesion by CT before and 4, 12 weeks later from administration of the molecular target drug.
Interventions/Control_2 A daily dose of the molecular target drug, sunitinib is determined by eGFR (50mg on over 45, 37.5mg on low by 45). And, we evaluate the lesion by CT before and 4, 12 weeks later from administration of the molecular target drug.
Interventions/Control_3 A daily dose of the molecular target drug, sorafenib is determined as 800mg. And, we evaluate the lesion by CT before and 4, 12 weeks later from administration of the molecular target drug.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Renal cell carcinoma with target lesion
Key exclusion criteria Renal cell carcinoma without target lesion
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironori Betsunoh
Organization Dokkyo Medical University
Division name Urology
Zip code
Address 880Kitakobayashi Mibu, Shimotsuga Tochigi 321-0293 JAPAN
TEL 0282872162
Email hirobets@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironori Betsunoh
Organization Dokkyo Medical University
Division name Urology
Zip code
Address 880Kitakobayashi Mibu, Shimotsuga Tochigi 321-0293 JAPAN
TEL 0282872162
Homepage URL
Email hirobets@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University, Department of Urology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 獨協医科大学

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2015 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 19 Day
Last modified on
2015 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021979

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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