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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002167
Receipt No. R000002656
Scientific Title Clinical test about the monitoring of the renal function disorder at the time of the cisplatin dosage by the inulin clearance measurement
Date of disclosure of the study information 2009/07/16
Last modified on 2012/01/11

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Basic information
Public title Clinical test about the monitoring of the renal function disorder at the time of the cisplatin dosage by the inulin clearance measurement
Acronym Evaluation of renal function during the cisplatin administration by the inulin
Scientific Title Clinical test about the monitoring of the renal function disorder at the time of the cisplatin dosage by the inulin clearance measurement
Scientific Title:Acronym Evaluation of renal function during the cisplatin administration by the inulin
Region
Japan

Condition
Condition The malignant tumor which needs the cisplatin dosage
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Under the administration of cisplatin,I measure the inulin clearance and inspect it about correlation with sCr Ccr eGFR.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation of inulin clearance and the 24 hours urine collection creatinine clearance
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 inulin
Interventions/Control_2
Interventions/Control_3
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
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria The eligibility criteria are as follows;
(1)Histologic or cytologic confirmation of cancer
(2)The patient who needs the more than 70mg/m2 cisplatin dosage(exclude tegaful gimeracil and oteracil potassium capsule)
(3)The patient are expected to survive more than 3 month
(4)The patient that eGFR are more than 50ml/min/1.73 at the time of an examination start
(5)Written informed consent

Key exclusion criteria The exclusion criteria are as follows;
(1)The patient who uses a medicine with the antioxygenation affecting the measurement of the inulin clearance(For example, vitaminE or probucol)
(2)The patient with contraindications to inulin
(3)The patient with it having been administered cisplatin within the past six months
(4)In addition, the patient who judged that a doctor was inappropriate
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minami Hironobu
Organization Kobe University Hospital
Division name oncology
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kobe University Hospital
Division name oncology
Zip code
Address
TEL
Homepage URL
Email yohei78525@gmail.com

Sponsor
Institute Kobe University Hospital
Institute
Department

Funding Source
Organization Kobe University Hospital
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

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 16 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
2009 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2012 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 07 Day
Last modified on
2012 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002656

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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