UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015768 |
|---|---|
| Receipt number | R000018160 |
| Scientific Title | A cohort study of pediatric chronic kidney disease |
| Date of disclosure of the study information | 2014/11/28 |
| Last modified on | 2020/06/05 13:44:14 |
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Basic information
Public title
A cohort study of pediatric chronic kidney disease
Acronym
P-CKD cohort study
Scientific Title
A cohort study of pediatric chronic kidney disease
Scientific Title:Acronym
P-CKD cohort study
Region
| Japan |
Condition
Condition
Pediatric pre-dialysis chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
- To elucidate the natural history, complications, and prognosis of pediatric chronic kidney disease (CKD)
- To investigate the mechanism, management (including surgery), and prognosis of complications associated with congenital anomalies of kidney and urinary tract (CAKUT), which is the major cause of pediatric CKD
Basic objectives2
Others
Basic objectives -Others
- To collect data on perinatal cortical necrosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Initiation of dialysis or renal transplantation (with the date and details of procedure)
Key secondary outcomes
Annual examinations:
1) Physical examination with the measurement date: height, weight, and blood pressure
2) Use of growth hormones
3) Blood test with the measurement date: Hb, Ht, serum Cr (SCr), Alb, BUN, Na, K, Ca, IP, ferritin, Fe, TIBC, intact PTH, cystatin C, and blood gas
4) Urinalysis with the measurement date: protein (qualitative and semiquantitative) and Cr
5) Use of milk for CKD patient
6) Death: the date, cause, and detailed course of death
Examinations for CAKUT (including neurogenic bladder)
1) Complicating congenital urinary tract abnormality
2) Obstructive uropathy (e.g. posterior urethral valves, ureteral cancer, hydronephrosis, hydroureter)
3) Bladder dysfunctions (including neurogenic bladder)
4) Date and process of detection (with height and SCr), date of surgery (with height and SCr), management procedure, and outcome of above 2) and 3)
5) Anal atresia
Investigation of (perinatal) cortical necrosis
1) Characteristics of the mother: age,
underlying disease, and prenatal medication
2) health status at birth: gestational age (weeks), parity , fetal complications, and Apgar score
3) Resuscitation
4) Complications within 14 days after birth including: pneumothorax, patent ductus arteriosus, pulmonary hypertension, gastrointestinal perforation, cerebral hemorrhage, subgaleal hematoma, periventricular leukomalacia, sepsis, oliguria, anuria
5) Interventions after birth (excluding medical therapy): ventilator, umbilical catheter, cardiac surgery, acute blood purification therapy, exchange transfusion
6) Medical therapy after birth
7) Minimum blood pressure value during neonatal period
8) Serum BUN and Cr: peak level within 14 days after birth
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
| 3 | months-old | <= |
Age-upper limit
| 180 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Predialysis patients with CKD in stage 3 or worse, based on the diagnostic criteria for CKD
Key exclusion criteria
History of dialysis or kidney transplantation
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Ishikura |
Organization
Kitasato University School of Medicine
Division name
Department of Pediatrics
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara
TEL
042-778-8111
kenzo@ii.e-mansion.com
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Hamasaki |
Organization
Faculty of Medicine, Toho University
Division name
Department of Nephrology
Zip code
143-8541
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541 , Japan
TEL
03-3762-4151
Homepage URL
yuhamasaki@med.toho-u.ac.jp
Sponsor or person
Institute
Japanese Pediatric CKD Study Group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee, Kitasato University Hospital
Address
1-15-1, Kitasato, Minami-ku, Sagamihara
Tel
042-778-8111
rinrib@med.kitasato-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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2010 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The cohort of pediatric CKD patients was established in 2010.
We have previously revealed the frequency, severity and clinical state , and short-term prognosis. The study will be continued to
Management information
Registered date
| 2014 | Year | 11 | Month | 28 | Day |
Last modified on
| 2020 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018160
