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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
