Unique ID issued by UMIN | UMIN000007091 |
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Receipt number | R000008224 |
Scientific Title | Study of Demonstration of Correlation between Cisplatin-induced Nephrotoxicity and Peak Concentration of Unbound Cisplatin in patients with renal impairment |
Date of disclosure of the study information | 2012/01/20 |
Last modified on | 2018/10/01 19:04:45 |
Study of Demonstration of Correlation between Cisplatin-induced Nephrotoxicity and Peak Concentration of Unbound Cisplatin in patients with renal impairment
Study of Demonstration of Correlation between Cisplatin-induced Nephrotoxicity and Peak Concentration of Unbound Cisplatin in patients with renal impairment
Study of Demonstration of Correlation between Cisplatin-induced Nephrotoxicity and Peak Concentration of Unbound Cisplatin in patients with renal impairment
Study of Demonstration of Correlation between Cisplatin-induced Nephrotoxicity and Peak Concentration of Unbound Cisplatin in patients with renal impairment
Japan |
Cancer patients with creatinine clearance < 60 mL/min, who will be treated with cisplatin-chemotherapy
Medicine in general | Nephrology |
Malignancy
NO
To investigate the relationship between the peak concentration(Cmax) of cisplatin and maximum serum creatinine(Scr), and to determine the target Cmax which is required to avoid maximum Scr > 1.5 mg/dL for cancer patients with creatinine clearance < 60 mL/min.
Pharmacokinetics
Primary endpoint: Relationship between Cmax and maximum Scr
Secondary endpoint: maximum Cystatine C, minimum estimated glomerular filtration rate
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1)Treatment with CDDP-containing chemotherapy
2)Creatinine clearance < 60 mL/min before the start of the present study
3)Eastern Cooperative Oncology Group performance status of 0 or 1
4)Over 20 years old
5)No prior chemotherapy or the completion of prior CDDP therapy at least three months before the start of the present study
6)Adequate water intake
7) Written informed consent
8) Adequate organ function except renal function
9) Life expectancy more than 3 months
1)Pregnant of breastfeeding
2)Serious psychiatric condition
3)Known to be positive for hepatitis B and C virus and human immunodeficiency virus
4)Severe hypertention
5)Severe heart disease (congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris or abnormal cardiac rhythm which need to treat)
6)Serious infectious disease at the time of screening
7)Patients in hemodialysis
8)Muscle diseases such as gigantism, acromegaly, and myasthenia gravis
9)Investigator's judgement.
25
1st name | |
Middle name | |
Last name | Tomoko Morita |
National Cancer Center Hospital East
Division of Pharmacy
6-5-1, Kashiwanoha, Kashiwa-shi, Chiba
04-7133-1111
toogawa@east.ncc.go.jp
1st name | |
Middle name | |
Last name | Tomoko Morita |
National Cancer Center Hospital East
Division of Pharmacy
6-5-1, Kashiwanoha, Kashiwa-shi, Chiba
04-7133-1111
toogawa@east.ncc.go.jp
National Cancer Center Hospital East, Division of Pharmacy
Foundation for Promotion of Cancer Research in Japan
Non profit foundation
NO
2012 | Year | 01 | Month | 20 | Day |
Unpublished
Completed
2011 | Year | 11 | Month | 29 | Day |
2012 | Year | 01 | Month | 01 | Day |
Blood samples (4 points) are collected in patients with renal dysfunction after the first administration of cisplatin to establish the appropriate administration of cisplatin.
2012 | Year | 01 | Month | 17 | Day |
2018 | Year | 10 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008224
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