UMIN-CTR Clinical Trial

Public title

Renoprotective Effect of Valsartan versus Spherical Carbon Adsorbent in
Children in the Conservative Phase of Chronic Kidney Disease:
A Randomized Controlled Trial

Acronym

P-CKD Trial

Scientific Title

Renoprotective Effect of Valsartan versus Spherical Carbon Adsorbent in
Children in the Conservative Phase of Chronic Kidney Disease:
A Randomized Controlled Trial

Scientific Title:Acronym

P-CKD Trial

Region

Japan

Condition

Children in the Conservative Phase of Chronic Kidney Disease

Classification by specialty

Nephrology

Pediatrics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Kenji Ishikura

Organization

National Center for
Child Health and Development

Division name

Division of Nephrology and Rheumatology

Zip code

Address

2-10-1 Okura, Setagaya-ku, Tokyo

TEL

03-3416-0181

Email

kenzo@ii.e-mansion.com

Name of contact person

1st name
Middle name
Last name	Yuko Hamasaki

Organization

Toho University Faculty of Medicine

Division name

Department of Pediatric Nephrology

Zip code

Address

6-11-1, Omori-Nishi, Ota-ku

TEL

03-3762-4151

Homepage URL

Email

yuhamasaki@med.toho-u.ac.jp

Institute

Japanese pediatric CKD study group

Institute

Department

Personal name

Organization

Japanese Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2011

Year

12

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2011

Year

10

Month

28

Day

Date of IRB

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

Other related information

Registered date

2011

Year

12

Month

20

Day

Last modified on

2018

Year

12

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008066