基本情報/Basic information |
一般向け試験名/Public title |
Aliskirenによる腎機能障害進展抑制効果を検証する無作為割付臨床試験 |
An Open label multi- facilities cooperation randomized control trial to verify renoprotective effects of Aliskiren treatment in the chronic kidney disease (CKD). |
一般向け試験名略称/Acronym |
Efficacy of Aliskiren in Japanese hypertensive patients with CKD. |
Aliskiren prevents the estimated glomerular filtration rate (eGFR) decrease in Japanese hypertensive patients with chronic kidney disease. (Al pen-Glow Study) |
科学的試験名/Scientific Title |
Aliskirenによる腎機能障害進展抑制効果を検証する無作為割付臨床試験 |
An Open label multi- facilities cooperation randomized control trial to verify renoprotective effects of Aliskiren treatment in the chronic kidney disease (CKD). |
科学的試験名略称/Scientific Title:Acronym |
Efficacy of Aliskiren in Japanese hypertensive patients with CKD. |
Aliskiren prevents the estimated glomerular filtration rate (eGFR) decrease in Japanese hypertensive patients with chronic kidney disease. (Al pen-Glow Study) |
試験実施地域/Region |
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目的/Objectives |
目的1/Narrative objectives1 |
CKD合併高血圧例におけるAliskiren治療の腎保護効果を明らかにする。本研究の目的は、angiotensin converting enzyme inhibitor (ACEI)もしくはangiotensin II receptor Blocker (ARB)治療が行われている状況において、Aliskiren治療が他の降圧治療よりもよりeGFRの低下を防止しうるかを検証するものである。 |
To clarify the renoprotective effects of Aliskiren treatment in hypertensive patients with CKD.The purpose of this study was to investigate whether Aliskiren prevents the eGFR decrease more than other anti-hypertensive agents under ACEI and/or ARB treatments. |
目的2/Basic objectives2 |
安全性・有効性/Safety,Efficacy |
目的2 -その他詳細/Basic objectives -Others |
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試験の性質1/Trial characteristics_1 |
検証的/Confirmatory |
試験の性質2/Trial characteristics_2 |
実務的/Pragmatic |
試験のフェーズ/Developmental phase |
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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 |
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介入1/Interventions/Control_1 |
試験対象は既にRAS抑制薬を服用しているCKD合併高血圧例。エントリー期間は2年。対象をAliskiren投与群とAliskiren以外の降圧薬投与群に分けそれぞれの治療を行う。Aliskirenは150mg/dayより投与を行い、効果不充分な時は適宜300mg/dayまで増量可能とする。 |
This study is a prospective randomized control trial. The entry period of this study is two years. Study subjects are hypertensive patients with CKD, taking RAS inhibitors (ACEI and/or ARB). These patients are randomly assigned to two groups, an Aliskiren treatment group (Aliskiren 150mg/day) and other anti-hypertensive agents treatment group. The dose of Aliskiren can be properly increased to 300 mg/day when the anti-hypertensive effect is insufficient. |
介入2/Interventions/Control_2 |
身長、体重、血圧、血清クレアチニン(eGFR)、尿中アルブミン、MCP-1、8-OHdG、NAG、β2マイクログロブリンを治療開始前と治療開始後2ヶ月に測定する。採血採尿は早朝空腹時に行う。 |
Their height, body weight, blood pressure, serum creatinine (e GFR), and urinary excretions of albumin, MCP-1, 8-OHdG, NAG and beta2 microgloburin are determined before (baseline) and after the treatment for two months. We collect fasting blood and first urine samples in early morning. |
介入3/Interventions/Control_3 |
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介入4/Interventions/Control_4 |
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介入5/Interventions/Control_5 |
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介入6/Interventions/Control_6 |
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介入7/Interventions/Control_7 |
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介入8/Interventions/Control_8 |
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介入9/Interventions/Control_9 |
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介入10/Interventions/Control_10 |
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適格性/Eligibility |
年齢(下限)/Age-lower limit |
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年齢(上限)/Age-upper limit |
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性別/Gender |
男女両方/Male and Female |
選択基準/Key inclusion criteria |
本研究の対象者は外来通院中のCKD合併高血圧例で以下の基準を満たすものとする。1)血圧が130/80 - 160/110 mmHgと血圧コントロールが著しく不良でないもの。2)ACEIもしくはARBを少なくとも6ヶ月以上服用している。3)CKD第二期-第四期である。4)本試験への参加同意が得られている。 |
The subjects enrolled in the present study are hypertensive out-patients with CKD, who fulfill the following criteria; 1) Mild or moderate hypertension defined as the blood pressure of 130 / 90 – 160 / 110 mmHg. 2) Taking of RAS inhibitors such as ACEI and/or ARB, for at least six months. 3) Corresponding to the second stage – the fourth stage of CKD (eGFR=15-89 ml/min). 4) The participation agreement of this study is obtained. |
除外基準/Key exclusion criteria |
1)CKD第5期(eGFRが15未満もしくは透析治療を受けている)。2)妊娠もしくは妊娠の可能性がある女性、授乳中の女性。3)重症かつ活動性のある他疾患を有するもの。4)重症高血圧例 (> 160/110 mmHg)。5)Aliskirenの投与禁忌に該当するもの。6)主治医が不適切と判断したもの。 |
1) Corresponding to the CKD 5th stage (eGFR < 15 ml/min, or receiving continuous dialysis). 2) Woman who has pregnancy or possibility of pregnancy and suckling. 3) To have other serious and active diseases such as severe hyperglycemia (HbA1c > 10%), liver dysfunction, cardiovascular disease and so on). 4) Severe hypertensive subjects (> 160 / 110 mmHg). 5) The patient that corresponds to contraindication of Aliskiren treatment. 6) Patient from whom physician in charge of treatment judged this study participation to be improper. |
目標参加者数/Target sample size |
300 |
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 |
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名 |
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ミドルネーム |
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姓 |
Susummu Ogawa MD, PhD |
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組織名/Organization |
東北大学病院 |
Tohoku University Hospital |
部署名/Division name |
腎・高血圧・内分泌科 |
Division of Nephrology, Endocrinology and Hypertension |
郵便番号/Zip code |
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住所/Address |
〒980-8574 仙台市青葉区星陵町1-1 |
1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan |
電話/TEL |
022-717-7166 |
試験のホームページURL/Homepage URL |
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Email/Email |
ogawa-s@hosp.tohoku.ac.jp |