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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030363
Receipt No. 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 2019/06/17

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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
Email 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
Email hoso9582@med.niigata-u.ac.jp

Sponsor
Institute Department of Applied Molecular Medicine, Kidney Research Center, Niigata University Graduate School of Medical and Dental Science
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
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
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034664

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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