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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000007091

Enrollment

Registered

2012-01-20

Start date

2012-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer patients with creatinine clearance &lt

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Primary endpoint: Relationship between Cmax and maximum Scr Secondary endpoint: maximum Cystatine C, minimum estimated glomerular filtration rate	—

Countries

Japan

Contacts

Public ContactTomoko Morita

National Cancer Center Hospital East Division of Pharmacy

toogawa@east.ncc.go.jp04-7133-1111

Outcome results