UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002167 |
|---|---|
| Receipt number | 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 20:17:59 |
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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
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
yohei78525@gmail.com
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002656
