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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038673
Receipt No. R000044079
Scientific Title Down syndrome's estimate Glomerular Filtration Rate formula study
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/25

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Basic information
Public title Children with Down syndrome's renal function formula study
Acronym DeGFR study
Scientific Title Down syndrome's estimate Glomerular Filtration Rate formula study
Scientific Title:Acronym DeGFR study
Region
Japan

Condition
Condition Down syndrome
eGFR<90 ml/min/1.73m2
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Since the renal function is evaluated by the formula from the standard values of healthy children, it is not valid for children with Down syndrome with different average height and muscle mass. Therefore, aiming to create a disease-specific renal function evaluation formula.
Basic objectives2 Others
Basic objectives -Others Construction of eGFR estimation formula using coefficients specific to children with Down syndrome of obtained from linear regression of inulin clearance and [(reference serum Cr/patient's serum Cr)*100]
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes inulin clearance
Blood test: creatinine, inulin
Before test start, 30 minutes after start, 90 minutes later

Urinalysis: creatinine, inulin
Before test start, at start, after 60 minutes, after 120 minutes
Key secondary outcomes Gender, age, height, complications
Blood test: Cystatin C, B2MG
Urinalysis: B2MG
separate quantitative renal function: 99mTc-DMSA
Congenital anomalies of the kidney and urinary tract: Abdominal ultrasonography
Comparison with eGFR obtained from Uemura's formula

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 All children are hospitalized for 2 days and examined. The same person is not measured repeatedly only once for each subject.
The amount of drugs and fluid replacement is calculated based on the weight at the time of hospitalization.
Abdominal ultrasonography and separate quantitative renal function (99mTc-DMSA) on day 1 and inulin clearance measurement on day 2.
The first day will be fasted after dinner, and the second day will not be allowed to drink from morning until the end.
Insert a bladder indwelling catheter for urinalysis during the study,
First, they receive an intravenous Ringer's solution load of 20 ml/kg body weight for 30 min to obtain good diuresis, following by a load of 5 ml/kg/h until testing completion. From 30 min after water loading, inulin give intravenously in a priming dose of 40 mg/kg body weight for 30 min calculated to achieve an extracellular fluid (ECF) level of 20 mg/dl. After the priming dose, administere inulin at a rate calculate to maintain a constant level in the blood. For this purpose, the rate of inulin infusion must equal that of loss in the urine. To calculate inulin loss, eGFR estimate from serum creatinine by the Uemura's formula. Therefore, the patients received an inulin load of 0.7 * eGFR ml/m2/h with calculation of body surface area by the Haycock method. We collect Urine samples in two periods of 1 h each, and blood samples twice from an indwelling cannula in the middle of urine collection, collect urine samples of all children by indwelling catheters.
After administration, confirm that there are no adverse events, and terminate the procedure.
Interventions/Control_2
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
2 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria Meets all of the following
Down syndrome
2 to 18 years old
eGFR<90 ml/min/1.73m2: Uemura's formula
Key exclusion criteria Any one of the following
congenital anomalies of the kidney and urinary tract
chronic glomerulonephritis
Respiratory or heart failure requiring oxygen administration
Under treatment for gastrointestinal symptoms and infectious diseases, inflammatory diseases
Women who are pregnant or may be pregnant
neuromuscular disease, muscle disease
Mental disorders
Immune disorder
malformation syndrome other than Down syndrome
Abnormal separate quantitative renal function (more than 20% left-right difference)
In this study, which the ratios of urine inulin excretion and intravenous inulin administration were <0.5 or >1.5
In this study, glomerular filtration rate >150 ml/min/1.73m2
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomohiko
Middle name
Last name Nishino
Organization Saitama Children's Medical Center
Division name Division of Nephrology
Zip code 330-8777
Address 1-2 Shintoshin, Chuo-ku, Saitama City, Saitama Prefecture 330 8777, Japan
TEL 048-601-2200
Email sinonosino@yahoo.co.jp

Public contact
Name of contact person
1st name Tomohiko
Middle name
Last name Nishino
Organization Saitama Children's Medical Center
Division name Division of Nephrology
Zip code 330-8777
Address 1-2 Shintoshin, Chuo-ku, Saitama City, Saitama Prefecture 330 8777, Japan
TEL 048-601-2200
Homepage URL http://www.pref.saitama.lg.jp/scm-c/rinsho/kenkyukadai_2018_05.html
Email sinonosino@yahoo.co.jp

Sponsor
Institute Division of Nephrology, Saitama Children's Medical Center
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama Children's Medical Center
Address 1-2 Shintoshin, Chuo-ku, Saitama City, Saitama Prefecture 330 8777, Japan
Tel 048-601-2200
Email chiken@scmc.pref.saitama.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 埼玉県立小児医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 29 Day
Date of IRB
2019 Year 01 Month 10 Day
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2020 Year 11 Month 30 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 11 Month 25 Day
Last modified on
2019 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044079

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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