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 2020/12/15 10:36:54

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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 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

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

9

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

No longer recruiting

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

2020 Year 12 Month 15 Day



Link to view the page

Value
https://center6.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