UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016915 |
|---|---|
| Receipt number | R000019635 |
| Scientific Title | The Establishment of Biomarkers in Patients with Nocturnal Enuresis: Serum Copeptin and Urinary Aquaporin-2 |
| Date of disclosure of the study information | 2015/03/25 |
| Last modified on | 2020/01/29 16:24:10 |
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Basic information
Public title
The Establishment of Biomarkers in Patients with Nocturnal Enuresis: Serum Copeptin and Urinary Aquaporin-2
Acronym
Serum Copeptin and Urinary Aquaporin-2 Measurement in Nocturnal Enuresis Patients
Scientific Title
The Establishment of Biomarkers in Patients with Nocturnal Enuresis: Serum Copeptin and Urinary Aquaporin-2
Scientific Title:Acronym
Serum Copeptin and Urinary Aquaporin-2 Measurement in Nocturnal Enuresis Patients
Region
| Japan |
Condition
Condition
Monosymptomatic Nocturnal Enuresis
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate serum Copeptin and urinary Aquaporin-2 levels during the course of Desmopressin treatment in patients with mono symptomatic nocturnal enuresis
Basic objectives2
Others
Basic objectives -Others
To assess whether serum Copeptin and/or urinary Aquaporin-2 is possible biomarkers for desmopressin treatment
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum Copeptin and urinary Aquaporin-2 levels: before the treatment, 4 and 8 weeks after the treatment, and after the treatment
Key secondary outcomes
Urine volume during the night, urinary osmolarity and creatinine before and after sleep : before the treatment, 4 and 8 weeks after the treatment, and after the treatment
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
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Oral desmopressin (Minirin Melt) 120 micrograms or 240 micrograms is given before sleep every day for 6 months
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
| 7 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with monosymptomatic nocturnal enuresis with more than 4 wet nights per week, without the previous history of desmopressin therapy
Key exclusion criteria
Patients with underlying pathologic conditions such as renal, endocrine, metabolic and neurological disorders resulted in nocturnal enuresis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Ohtomo |
Organization
Juntendo University Nerima Hospital
Division name
Department of Pediatrics
Zip code
1710033
Address
3-1-10 Takanodai, Nerima, Tokyo
TEL
+81-3-59233111
ohtomo@juntendo-nerima.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Katsuki |
Organization
Juntendo University Nerima Hospital
Division name
GCP Center
Zip code
1710033
Address
3-1-10 Takanodai, Nerima, Tokyo
TEL
+81-3-59233111
Homepage URL
gcp@juntendo-nerima.jp
Sponsor or person
Institute
Department of Pediatrics, Juntendo University Graduated School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ferring Pharmaceuticals Co Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Pharmacology, Keio University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Nerima Hospital
Address
3-1-10 Takanodai, Nerima-ku, Tokyo
Tel
03-5923-3111
gcp@juntendo-nerima.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
順天堂大学医学部附属練馬病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.auajournals.org/doi/10.1016/j.juro.2017.04.088
Publication of results
Published
Result
URL related to results and publications
https://www.auajournals.org/doi/10.1016/j.juro.2017.04.088
Number of participants that the trial has enrolled
32
Results
1 Urinary aquaporin 2 appears to be a biomarker of desmopressin treatment effectiveness during the Treatment of Monosymptomatic Nocturnal Enuresis.
2 Plasma copeptin levels before treatment are predictive of desmopressin response.
Results date posted
| 2020 | Year | 01 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Children 6 to 11 years old with monosymptomatic nocturnal enuresis
Participant flow
After inclusion criteria are confirmed, the study will be explained, and if consent is obtained from the patient and his / her family, a treatment study will be started.
Adverse events
no
Outcome measures
1) Primary Endpoint
Day / night ratio of blood Copeptin concentration and urinary AQP2 concentration (4 weeks, 8 weeks after the start of treatment, when nocturnal urine disappears *)
2) Secondary Endpoint
Blood sodium level
Urine volume, urine osmotic pressure / specific gravity, urine creatine (4 weeks and 8 weeks after start of treatment, when nocturnal urine disappears)
Dinner, bedtime, wake-up time
Changes in night urine episodes
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 25 | Day |
Last modified on
| 2020 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019635
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