UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047572 |
|---|---|
| Receipt number | R000052318 |
| Scientific Title | A clinical trial to develop an equation to calculate estimated glomerular filtration rate in children with Down syndrome |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2024/05/13 17:09:01 |
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Basic information
Public title
Down syndrome's estimated glomerular filtration rate trial
Acronym
DeGFR trial
Scientific Title
A clinical trial to develop an equation to calculate estimated glomerular filtration rate in children with Down syndrome
Scientific Title:Acronym
DeGFR trial
Region
| Japan |
Condition
Condition
Down syndrome
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establish a formula for calculating estimated glomerular filtration rate specific to Down syndrome.
Basic objectives2
Others
Basic objectives -Others
Development of a polynomial approximation for the relationship between glomerular filtration rateobtained from inulin clearance and the commonly used estimated glomerular filtration rate equation.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between glomerular filtration rate obtained from inulin clearance and the ratio of reference serum creatinine levels in Down syndrome to serum creatinine levels in affected children.
Key secondary outcomes
Development of a polynomial approximation for the relationship between glomerular filtration rateobtained from inulin clearance and the commonly used estimated glomerular filtration rate equation.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Inulin clearance measurements were performed at our institution.
Consent was obtained for this trial.
Key exclusion criteria
1) Abnormally low (less than 0.5) or abnormally high (greater than 0.5) ratio of urinary inulin excretion to blood inulin concentration
2) GFR greater than 150 ml/min/1.73m2
3) Patients who have had surgery for congenital heart disease or are expected to have surgery in the future
4) Patients with severe renal dysfunction (anuria, oliguria, on dialysis)
5) Respiratory failure or heart failure requiring oxygen administration
6) Patients undergoing treatment for gastrointestinal symptoms or common cold symptoms
7) Women who are pregnant, may become pregnant, or who are breast-feeding
8) Patients with neurological disorders taking antiepileptic drugs
9) Complications of chromosomal or genetic abnormalities other than DS
10) If the doctor in charge judges that the patient is inappropriate to participate in this trial
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Nishino |
Organization
Teikyo University School of Medicine
Division name
Department of Pediatrics
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
TEL
+81-3-3964-4090
sinonosino@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Nishino |
Organization
Teikyo University School of Medicine
Division name
Department of Pediatrics
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
TEL
+81-3-3964-4090
Homepage URL
sinonosino@yahoo.co.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo Universitys ethics review board
Address
2-11-1, Kaga, Itabashi-ku, Tokyo
Tel
03-3964-7256
turb-office@teikyo-u.ac.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
帝京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | 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
1
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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
N.A.
Management information
Registered date
| 2022 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052318
