UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029215
Receipt number R000032499
Scientific Title Kidney protective effect of magnesium supplementation on cisplatin-containing chemotherapy in pediatric cancer: a randomized controlled,phase 2 study
Date of disclosure of the study information 2017/09/20
Last modified on 2021/01/05 18:07:50

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Basic information

Public title

Kidney protective effect of magnesium supplementation on cisplatin-containing chemotherapy in pediatric cancer: a randomized controlled,phase 2 study

Acronym

Mg-rPII

Scientific Title

Kidney protective effect of magnesium supplementation on cisplatin-containing chemotherapy in pediatric cancer: a randomized controlled,phase 2 study

Scientific Title:Acronym

Mg-rPII

Region

Japan


Condition

Condition

pediatric oncology

Classification by specialty

Hematology and clinical oncology Pediatrics

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The primary aim of this study is to show the nephroprotective effect of Mg supplementation from cisplatin-induced nephrotoxicity in pediatric cancer patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

comparison frequency of nephrotoxicity between the two groups (Mg+ and Mg-)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Mg+ group: Mg 24-hour continuous infusion (15mEq/m2)

Interventions/Control_2

Mg- group: without Mg supplementation

Interventions/Control_3


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

0 years-old <=

Age-upper limit

20 years-old >

Gender

Male and Female

Key inclusion criteria

cisplatin-containing courses for the treatment of newly-diagnosed pediatric cancer

Key exclusion criteria

heart failure
dialysis patient
severe infection

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Matsui
Middle name
Last name Motohiro

Organization

Tokyo Metropolitan Children's Medical center

Division name

Department of Pediatric Hematology Oncology

Zip code

1838561

Address

2-8-29,Musasshidai, Fuchu-shi, Tokyo, Japan

TEL

042-300-5111

Email

motohiro_matsui@tmhp.jp


Public contact

Name of contact person

1st name Matsui[
Middle name
Last name Motohiro

Organization

Tokyo Metropolitan Children's Medical center

Division name

Department of Pediatric Hematology Oncology

Zip code

1838561

Address

2-8-29,Musasshidai, Fuchu-shi, Tokyo, Japan

TEL

042-300-5111

Homepage URL


Email

motohiro_matsui@tmhp.jp


Sponsor or person

Institute

Tokyo Metropolitan Children's Medical center

Institute

Department

Personal name



Funding Source

Organization

Tokyo Metropolitan Children's Medical center

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Metropolitan Institute of Gerontology

Address

35-2 Sakae-cho,Itabashi-ku, Tokyo, 173-0015,Japan

Tel

0339643241

Email

kouhou@tmghig.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



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 20 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

Open public recruiting

Date of protocol fixation

2017 Year 01 Month 06 Day

Date of IRB

2017 Year 02 Month 28 Day

Anticipated trial start date

2017 Year 07 Month 01 Day

Last follow-up date

2023 Year 07 Month 01 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 09 Month 20 Day

Last modified on

2021 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032499


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name