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

JRCT ID: jRCTs031180329

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non small cell lung cancer
• Date of first enrollment: 01/12/2019
• Target sample size: 9
• Study type: Interventional
• Intervention(s): Thienam (0g, 0.5g, or 1.0g) is administered before the initial cisplatin (75mg/m2)-based chemotherapy in patients with non-small cell lung cancer (stage 4).

Outcome(s)

• Primary Outcome: Pharmacokinetics of cisplatin in combination with cilastatin (Cmax, T1/2, AUC)
• Secondary Outcome: The change in eGFR at day 8 comparing with baseline

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Saito Akihiko
• Secondary ID(s): UMIN000030363