UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038673 |
|---|---|
| Receipt number | 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 | 2020/05/26 13:47:46 |
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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
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
sinonosino@yahoo.co.jp
Sponsor or person
Institute
Division of Nephrology, Saitama Children's Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044079
