UMIN-CTR 臨床試験登録情報の閲覧

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試験進捗状況 試験中止/Terminated
UMIN試験ID UMIN000006917
受付番号 R000008066
科学的試験名 保存期の小児慢性腎臓病患者を対象としたバルサルタンと球形吸着炭の腎保護効果に関するランダム化比較試験
一般公開日(本登録希望日) 2011/12/20
最終更新日 2018/12/25

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。

基本情報/Basic information
一般向け試験名/Public title 保存期の小児慢性腎臓病患者を対象としたバルサルタンと球形吸着炭の腎保護効果に関するランダム化比較試験 Renoprotective Effect of Valsartan versus Spherical Carbon Adsorbent in
Children in the Conservative Phase of Chronic Kidney Disease:
A Randomized Controlled Trial
一般向け試験名略称/Acronym 小児CKDに対するバルサルタンと球形吸着炭のRCT P-CKD Trial
科学的試験名/Scientific Title 保存期の小児慢性腎臓病患者を対象としたバルサルタンと球形吸着炭の腎保護効果に関するランダム化比較試験 Renoprotective Effect of Valsartan versus Spherical Carbon Adsorbent in
Children in the Conservative Phase of Chronic Kidney Disease:
A Randomized Controlled Trial
科学的試験名略称/Scientific Title:Acronym 小児CKDに対するバルサルタンと球形吸着炭のRCT P-CKD Trial

対象疾患名/Condition 保存期の小児慢性腎臓病 Children in the Conservative Phase of Chronic Kidney Disease
疾患区分1/Classification by specialty
腎臓内科学/Nephrology 小児科学/Pediatrics
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的1/Narrative objectives1 保存期の小児慢性腎臓病患者(CKDステージ3及び4)を対象としたランダム化比較試験により,バルサルタンの有効性,安全性を評価する.また,球形吸着炭の有効性及び安全性に関する情報を収集する. 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.
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes 登録日を起算日とし,以下の①~③のイベント及びあらゆる原因による死亡を含めた計4項目のイベントのうち最も早い発生日までの期間
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
副次アウトカム評価項目/Key secondary outcomes (1)Time to treatment failure
(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

試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 実薬・標準治療対照/Active
動的割付/Dynamic allocation はい/YES
試験実施施設の考慮/Institution consideration 施設を考慮していない/Institution is not considered as adjustment factor.

群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
介入1/Interventions/Control_1 バルサルタン0.5 mg/kg/日(最大投与量40 mg/日)で開始する.1日1回(朝食後)経口投与とし,粉砕化・割錠ともに可とする.
経口投与開始後に血清クレアチニン値上昇,血清カリウム高値,低血圧などの有害事象がなければ,2ヶ月以内にバルサルタン1.7 mg/kg/日(最大投与量80 mg/日)に増量する.ただし,有害事象等で最大投与量への増量が困難な場合,0.5~1.7 mg/kg/日の範囲で継続してよい.
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.
介入2/Interventions/Control_2 球形吸着炭0.1 g/kg/日(最大投与量6 g/日)を2~3回に分割し,食間に経口投与する. 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.








年齢(下限)/Age-lower limit
1 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
19 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria (1)登録時の年齢が1~19歳である.
(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.
除外基準/Key exclusion criteria (1)腎移植の既往がある.
(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.
目標参加者数/Target sample size 120

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

石倉 健司

Kenji Ishikura
所属組織/Organization 国立成育医療研究センター National Center for
Child Health and Development
所属部署/Division name 腎臓リウマチ膠原病科 Division of Nephrology and Rheumatology
郵便番号/Zip code
住所/Address 東京都世田谷区大蔵2-10-1 2-10-1 Okura, Setagaya-ku, Tokyo
電話/TEL 03-3416-0181

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

濱崎 祐子

Yuko Hamasaki
組織名/Organization 東邦大学医学部 Toho University Faculty of Medicine
部署名/Division name 小児腎臓学講座 Department of Pediatric Nephrology
郵便番号/Zip code
住所/Address 大田区大森西6-11-1 6-11-1, Omori-Nishi, Ota-ku
電話/TEL 03-3762-4151
試験のホームページURL/Homepage URL

機関名/Institute その他 Japanese pediatric CKD study group

研究費提供組織/Funding Source
機関名/Organization その他 Japanese Ministry of Health, Labour and Welfare
組織の区分/Category of Funding Organization その他/Other
研究費拠出国/Nationality of Funding Organization 日本 Japan

その他の関連組織/Other related organizations

その他の研究費提供組織/Name of secondary funder(s)

IRB等連絡先(公開)/IRB Contact (For public release)



他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設名称/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

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2011 12 20

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description

試験進捗状況/Recruitment status 試験中止/Terminated
プロトコル確定日/Date of protocol fixation
2011 10 28
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2011 12 01
フォロー終了(予定)日/Last follow-up date
2023 10 01
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

管理情報/Management information
登録日時/Registered date
2011 12 20
最終更新日/Last modified on
2018 12 25

閲覧ページへのリンク/Link to view the page

登録日時 ファイル名

登録日時 ファイル名

登録日時 ファイル名

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