UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030363 |
|---|---|
| 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 | 2024/04/30 15:54:19 |
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Basic information
Public 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
Acronym
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
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
Scientific Title:Acronym
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
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Nephrology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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).
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Pharmacokinetics (Cmax, T1/2, and AUC) of cisplatin under the co-administration with cilastatin
Key secondary outcomes
The change in the absolute value and percentage of the estimated glomerular filtration rate (eGFR) 8 days after the administration of cisplatin from baseline
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Thienam(R) 0g is administered before the initial cisplatin (75mg/m2)-based chemotherapy in patients with non-small cell lung cancer (stage 4).
Interventions/Control_2
Thienam(R) 0.5g is administered before the initial cisplatin (75mg/m2)-based chemotherapy in patients with non-small cell lung cancer (stage 4).
Interventions/Control_3
Thienam(R) 1.0g is administered before the initial cisplatin (75mg/m2)-based chemotherapy in patients with non-small cell lung cancer (stage 4).
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Saito |
Organization
Kidney Research Center, Niigata University Graduate School of Medical and Dental Science
Division name
Department of Applied Molecular Medicine
Zip code
951-8510
Address
1-757 Asahimachidori, Chuo-ku, Niigata
TEL
025-227-0915
akisaito@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Hosojima |
Organization
Kidney Research Center, Niigata University Graduate School of Medical and Dental Science
Division name
Department of Clinical Nutrition Science
Zip code
951-8510
Address
1-757 Asahimachidori, Chuo-ku, Niigata
TEL
025-368-9312
Homepage URL
hoso9582@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Applied Molecular Medicine, Kidney Research Center, Niigata University Graduate School of Medical and Dental Science
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Central Review Board of Clinical Research
Address
1-757 Asahimachidori, Chuo-ku, Niigata
Tel
025-368-9343
crbcr@adm.niigata-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
新潟大学医歯学総合病院 (新潟県) Niigata University Medical and Dental Hospital (Niigata Prefecture)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 26 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/latest-detail/jRCTs031180329
Publication of results
Unpublished
Result
URL related to results and publications
https://jrct.niph.go.jp/latest-detail/jRCTs031180329
Number of participants that the trial has enrolled
9
Results
The primary endpoint was the pharmacokinetics of cisplatin in combination with cilastatin, which evaluated serum platinum concentrations. Cmax were 2.44+-0.09 microg/mL, 2.61+-0.34 microg/mL, and 2.43+-0.26 microg/mL, and T1/2 were 114.9+-14.5 h, 114.6+-31.7 h, 76.8+-3.4 h, and AUC were 8574+-1418 microg min/mL, 8184+-2480 microg min/mL, 7764+-1217 maicrog min/mL in the 0 g, 0.5 g, and 1 g Thienam groups, respectively.
Results date posted
| 2024 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 65 [range, 47-70] years old, and 8 (89%) were male. The stages were unresectable stage 3 in one, stage 4A in four, and stage 4B in four, respectively.
Participant flow
The pace of registration was almost as expected compared to the initial assumption. Eligibility was evaluated for 9 patients who obtained consent, and and 9 patients participated in the study. In practice, patients were first allocated to the 0g Thienam group, and after three patients were allocated to the 0g group, the next three patients were allocated to the 0.5g group. The next three patients were then allocated to the 1.0 g group after confirming that there were no more than two CTCAE version 5.0 grade 3 or higher renal function-related adverse events in the 0.5 g group. All nine participants completed the study.
Adverse events
No serious adverse events occurred; only one case of Grade 3 or higher adverse event, leukopenia, which was thought to be due to chemotherapy.
Outcome measures
In chemotherapy including cisplatin administered to chemotherapy-naive patients with advanced non-small cell lung cancer, the T1/2 and AUC of serum platinum concentration were affected, especially in the high-dose thienam group. No effect on renal function, and no serious adverse events were observed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034664
