UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Renoprotective Effect of Valsartan versus Spherical Carbon Adsorbent in Children in the Conservative Phase of Chronic Kidney Disease: A Randomized Controlled Trial
Title of the study (Brief title)	P-CKD Trial
Region	Japan

Condition
Condition	Children in the Conservative Phase of Chronic Kidney Disease
Classification by specialty	Nephrology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the efficacy and safety of Valsartan by conducting a randomized controlled trial in patients in the conservation period of childhood chronic renal disease (CKD stages 3 and 4). Also, we collect information about the efficacy and safety of a spherical carbon adsorbent.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The period until the date of the earliest development of any event among four events, including the following events, (1)-(3), and death due to any cause, with the date of registration as the initial date of reckoning: (1)Elevation 1.5 times or higher than the base-line value of serum creatinine concentration (2)Dialysis introduction (3)Performance of renal transplant
Key secondary outcomes	(1) Time to treatment failure The period until the date of the earliest development of any event among eight events, including the following events, 1 - 4, in addition to main endpoint events, 1 - 3, and death due to any cause, with the date of registration as the initial date of reckoning: If it can be confirmed by observation twice in a row that the rate of test drug compliance during the study period is less than 50% (excluding drug discontinuation and drug withdrawal due to adverse events or according to a doctor's direction). Drug compliance shall be judged based on the mean amount of the drug taken during a week on the basis of the patient's clinical diary. If the less than 50% test drug compliance rate during the study period can be confirmed by observation twice in a row, the date of the first confirmation of the less than 50% compliance rate shall be the date of event onset. If the doctor in attendance judges that treatment with the test drug needs to be changed because the effect of the test drug is inadequate. If the doctor in attendance judges that it is difficult to continue the treatment with the test drug due to the onset of an adverse event, etc. If the patient or the patient's legal guardian offers discontinuation of the test drug therapy. (In the case of falling under any of the above reasons 1) to 3), reason 4) shall not be applicable.) (2) Time to the day of dialysis introduction or that of kidney transplantation (3) Estimated glomerular filtration rate (4) Reciprocal inclination of serum creatinine level (5) Urinary protein to creatinine ratio (6) Rate of CKD stage migration (7) Adverse events during the treatment with the test drug

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	It starts with Valsartan at a dose of 0.5 mg/kg/day (maximal dose 40 mg/day). It is to be given by oral administration once a day (after breakfast), and the percent tablet can be crushed or bisected. The dose of Valsartan is to be increased to 1.7 mg/kg/day (maximal dose 80 mg/day) within two months after the start of oral administration, if there is no occurrence of adverse events such as an elevated serum creatinine concentration, high serum potassium level, and low blood pressure. But the drug administration may be continued in the range of 0.5 to 1.7 mg/kg/day, if it is difficult to increase the dose to the maximal dose due to an adverse event.
Interventions/Control_2	A dose of a spherical carbon adsorbent of 0.1 g/kg/day (maximal dose 6 g/day) is administered orally in two or three divided doses between meals.
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	1 years-old <=
Age-upper limit	19 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Patient age at the registration is 1-19 years. (2)The patient falls under CKD stage 3 or 4 in the pediatric CKD stage judgment list. (3)The patient is able to go to hospital through the study treatment period. (4)Writen consent to participation in this study has been obtained from the patient's legal guardian.
Key exclusion criteria	(1)The patient has a history of renal transplant. (2)The patient receives dialysis therapy at registration or needs to undergo dialysis therapy promptly. (3)The patient has a serious impaired liver function (GOT or GPT higher than 2.5 times of the upper limit of the reference value) at registration. (4)White cell count is less than 3000/mm3 or platelet count is less than 100,000/mm3 at registration. (5)Serum potassium level exceeds the upper limit of the reference value at registration despite appropriate treatment. (6)A patient with bilateral renal artery stenosis or patient having only one kidney with renal artery stenosis. (7)The patient has a passage disorder to the alimentary canal. (8)The patient has poorly controlled hypertension at registration. More than 99 percentile in the blood pressure reference value list according to the sex and age of children. (9)Patient with a previous history of hypersensitivity to an ingredient of Valsartan or other ARB or the spherical carbon adsorbent. (10)ACEI, ARB or the spherical carbon adsorbent was given within 14 days before registration. (11) The patient is participating in other clinical study or trial at registration. (12)A woman who is pregnant or of childbearing potential or who is nursing. (13)A woman who wishes to become pregnant during the study period. (14)In addition, patients who are judged to be inappropriate for study subjects by the doctor in attendance.
Target sample size	120

Research contact person
Name of lead principal investigator	Kenji Ishikura
Organization	National Center for Child Health and Development
Division name	Division of Nephrology and Rheumatology
Address	2-10-1 Okura, Setagaya-ku, Tokyo
TEL	03-3416-0181
Email	kenzo@ii.e-mansion.com

Public contact
Name of contact person	Yuko Hamasaki
Organization	Toho University Faculty of Medicine
Division name	Department of Pediatric Nephrology
Address	6-11-1, Omori-Nishi, Ota-ku
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	Japanese Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東京都立小児総合医療センター腎臓内科（東京都），あいち小児保健医療総合センター（愛知県），国立成育医療研究センター（東京都）等

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 20 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 10 Month 28 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date	2023 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 12 Month 20 Day
Last modified on	2018 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008066