UMIN-CTR Clinical Trial

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	0
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	Terminated
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 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 11 Month 25 Day
Last modified on	2020 Year 05 Month 26 Day

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