A preliminary open-labeled pharmacokinetic study to examine the effect of cilastatin on the prevention of acute kidney injury in cancer patients undergoing cisplatin-based chemotherapy
Phase 1
- Conditions
- on small cell lung cancer
- Registration Number
- JPRN-jRCTs031180329
- Lead Sponsor
- Saito Akihiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
Those with Non-small cell lung cancer, stage 4.
Those with planning chemotherapy including cisplatin, who have never had chemotherapy so far.
Those with PS 0 or 1.
Those who have given written informed consent on the use of their clinical data for this trial.
Exclusion Criteria
Those with impaired renal function: eGFR<60mL/min/1.73m2
Those who has disease or symptoms thought to be affecting the judgment of efficacy or safety.
Those who received antibiotics, antiviral drugs, antifungal drugs within 14 days before incorporation (except for external application, eye drops, or nose drops).
Female patients during pregnancy, breast-feeding or pregnancy.
Those who judged that the research director is inappropriate as the research subject.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics of cisplatin in combination with cilastatin (Cmax, T1/2, AUC)
- Secondary Outcome Measures
Name Time Method The change in eGFR at day 8 comparing with baseline