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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000011150
受付番号 R000013052
科学的試験名
一般公開日(本登録希望日) 2013/07/09
最終更新日 2015/07/09

※ 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
Switching hemodialysis patients from sevelamer hydrochloride to bixalomer: a single-center, non-randomized controlled analysis of efficacy and effects on gastrointestinal symptoms and metabolic acidosis
一般向け試験名略称/Acronym
Switching from sevelamer hydrochloride to bixalomer in hemodialysis patients
科学的試験名/Scientific Title
Switching hemodialysis patients from sevelamer hydrochloride to bixalomer: a single-center, non-randomized controlled analysis of efficacy and effects on gastrointestinal symptoms and metabolic acidosis
科学的試験名略称/Scientific Title:Acronym
Switching from sevelamer hydrochloride to bixalomer in hemodialysis patients
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition
End-stage renal failure, Hemodialysis
疾患区分1/Classification by specialty
腎臓内科学/Nephrology
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/Objectives
目的1/Narrative objectives1
Safety and effectiveness of switching maintenance dialysis patients from sevelamer hydrochloride to bixalomer
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 探索的/Exploratory
試験の性質2/Trial characteristics_2 説明的/Explanatory
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Improvement of gastrointestinal symptoms 12 weeks after the switch
副次アウトカム評価項目/Key secondary outcomes
Improvement in metabolic acidosis, changes in blood biochemistry, and safety 12 weeks after the switch

基本事項/Base
試験の種類/Study type

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 非ランダム化/Non-randomized
ランダム化の単位/Randomization unit
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無対照/Uncontrolled
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
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
医薬品/Medicine
介入1/Interventions/Control_1
Intervention group:Patients were switched from sevelamer hydrochloride to bixalomer (1:1 dose)
介入2/Interventions/Control_2
Control gtoup: Patients without sevelamer hydrochloride agent were enrolled as a control group
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
80 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Patients were included if they (1) were aged 20 to 80 years, were stable on hemodialysis sessions started at least 1 year before study entry; (2) provided written informed consent to participation; (3) had not changed their
9
regimen of phosphate-lowering drugs, cinacalcet hydrochloride (if used), and other medications that could affect serum phosphorus levels for at least 28 days before study entry; (4) had not changed their dialysis regimens for at least 28 days before study entry; (5) had not changed other factors, including dietary therapy and concomitant drugs, during the study period; and (6) were in good general health, with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) grade of 0 or 1
除外基準/Key exclusion criteria
Patients were excluded if they (1) had a history of gastrointestinal surgery (excluding polypectomy), dysphagia, ileus, gastrointestinal bleeding, severe persistent constipation or diarrhea, or had received parathyroid intervention within 3 months of study entry, (2) showed unstable control of serum phosphorus and calcium levels; or (3) were in poor general health, or had a major concomitant malignant disease or another medical condition likely to result in death within 6 months of study entry.
目標参加者数/Target sample size 30

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

ミドルネーム


ミドルネーム
Shingo Hatakeyama
所属組織/Organization
Hirosaki University Graduate School of Medicine
所属部署/Division name
Urology
郵便番号/Zip code
住所/Address
5 Zaifu-chou
電話/TEL +81-172-39-5091
Email/Email shingorilla2@gmail.com

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

ミドルネーム


ミドルネーム
Shingo Hatakeyama
組織名/Organization
Hirosaki University, School of Medicine
部署名/Division name
Urology
郵便番号/Zip code
住所/Address
5 Zaifu-chou
電話/TEL +81-172-39-5091
試験のホームページURL/Homepage URL
Email/Email shingorilla2@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 OYOKYO Kidney Research Institute
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 OYOKYO Kidney Research Institute
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 財団/Non profit foundation
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

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)
組織名/Organization

住所/Address

電話/Tel
Email/Email

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/Institutions
試験実施施設名称/Institutions

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
2013 07 09

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 最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications http://www.biomedcentral.com/1471-2369/14/222
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results
Before switching, symptoms of epigastric fullness were significantly worse in the switch than in the control group. Twelve weeks after the switch, reflux, epigastric fullness, and constipation had improved significantly in the switch group. Other factors, including stomach ache, diarrhea, and form of stool, did not change significantly. Blood gas analysis showed that metabolic acidosis was significantly improved by switching. Four patients (14%) experienced grade 1 adverse events, all of which improved immediately after stopping BXL. Major adverse events were diarrhea and abdominal discomfort. 
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/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2012 06 01
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
2012 07 01
フォロー終了(予定)日/Last follow-up date
2012 10 30
入力終了(予定)日/Date of closure to data entry
2013 04 01
データ固定(予定)日/Date trial data considered complete
2013 05 01
解析終了(予定)日/Date analysis concluded
2013 08 01

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2013 07 09
最終更新日/Last modified on
2015 07 09


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000013052
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013052

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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