Unique ID issued by UMIN | UMIN000030363 |
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Receipt number | R000034664 |
Scientific Title | 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 |
Date of disclosure of the study information | 2017/12/26 |
Last modified on | 2020/12/15 10:36:54 |
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
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
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
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
Japan |
Non-small cell lung cancer
Pneumology | Nephrology |
Malignancy
NO
To evaluate the serum and urinary cisplatin (or platinum) concentration and the safety in patients with non-small cell lung cancer (stage 4) who undergo an initial cisplatin-based chemotherapy after the administration of Thienam(R) (imipenem/sodium cilastatin).
PK,PD
Exploratory
Explanatory
Phase I
Pharmacokinetics (Cmax, T1/2, and AUC) of cisplatin under the co-administration with cilastatin
The change in the absolute value and percentage of the estimated glomerular filtration rate (eGFR) 8 days after the administration of cisplatin from baseline
Interventional
Parallel
Non-randomized
Open -no one is blinded
Dose comparison
No need to know
3
Treatment
Medicine |
Thienam(R) 0g is administered before the initial cisplatin (75mg/m2)-based chemotherapy in patients with non-small cell lung cancer (stage 4).
Thienam(R) 0.5g is administered before the initial cisplatin (75mg/m2)-based chemotherapy in patients with non-small cell lung cancer (stage 4).
Thienam(R) 1.0g is administered before the initial cisplatin (75mg/m2)-based chemotherapy in patients with non-small cell lung cancer (stage 4).
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1. Those between 20 and 70 years old
2. Those who have non-small cell lung cancer (stage 4)
3. Those who undergo an initial cisplatin-based chemotherapy
4. Those with the performance status (PS) 0 or 1
5. Those who have given written informed consent on the use of their clinical data for this study
1. Those with kidney dysfunction (eGFR<60 mL/min/1.73m2)
2. Those who have diseases or symptoms considered to have an effect on the determination of efficacy or safety
3. Those who received antibiotics, antiviral drugs, or antifungal drugs (except for topical application, eye drops, or nose drops) within 14 days before enrollment
4. Those who are considered not eligible for this study by attending doctors due to any medical reasons
9
1st name | Akihiko |
Middle name | |
Last name | Saito |
Kidney Research Center, Niigata University Graduate School of Medical and Dental Science
Department of Applied Molecular Medicine
951-8510
1-757 Asahimachidori, Chuo-ku, Niigata
025-227-0915
akisaito@med.niigata-u.ac.jp
1st name | Michihiro |
Middle name | |
Last name | Hosojima |
Kidney Research Center, Niigata University Graduate School of Medical and Dental Science
Department of Clinical Nutrition Science
951-8510
1-757 Asahimachidori, Chuo-ku, Niigata
025-368-9312
hoso9582@med.niigata-u.ac.jp
Department of Applied Molecular Medicine, Kidney Research Center, Niigata University Graduate School of Medical and Dental Science
Japan Agency for Medical Research and Development
Government offices of other countries
Japan
Niigata University Central Review Board of Clinical Research
1-757 Asahimachidori, Chuo-ku, Niigata
025-368-9343
crbcr@adm.niigata-u.ac.jp
NO
新潟大学医歯学総合病院 (新潟県) Niigata University Medical and Dental Hospital (Niigata Prefecture)
2017 | Year | 12 | Month | 26 | Day |
Unpublished
9
No longer recruiting
2017 | Year | 11 | Month | 20 | Day |
2018 | Year | 11 | Month | 19 | Day |
2017 | Year | 12 | Month | 26 | Day |
2020 | Year | 03 | Month | 31 | Day |
2017 | Year | 12 | Month | 12 | Day |
2020 | Year | 12 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034664
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