UMIN-CTR Clinical Trial

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
Email	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
Email	yuhamasaki@med.toho-u.ac.jp

Sponsor
Institute	Japanese Pediatric CKD Study Group
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018160