Queen's University Investigation of Calcification in Chronic Kidney Disease (QUICK)
The Use of Bisphosphonates to Prevent or Delay the Progression of Vascular Calcification in End-Stage Renal Disease: A Randomized Controlled Trial
Kidney disease is a fundamental part of medicine because of its prominence in Western society. Common conditions such as diabetes, hypertension and kidney infections can all progress to End-Stage Renal Disease (ESRD) also known as Stage 5 chronic kidney disease (CKD 5). Once ESRD has begun, kidney function is poor at best, thus the body is unable to effectively clear harmful toxins from the blood.
A common feature of ESRD is vascular calcification, a process where blood vessels (especially arteries) attract deposits of the mineral calcium. Over time, these deposits harden and thicken in the layers of blood vessels, which limit blood flow to body tissues and can produce significant disease including hypertension, heart disease and stroke. Although the process of vascular calcification is unknown, there is mounting evidence that it is mediated by cellular events that are similar to those seen in bone formation with in the body (osteogenesis). With this point in mind, it has been suggested that agents medicine employs to limit excess bone formation will reduce the rate of vascular calcification in CKD Stage 5.
This study will employ one group of drugs called bisphosphonates which have been used to limit bone formation. It will study their effect on vascular calcification in adult dialysis patients.
調査の概要
詳細な説明
Presently, there exist few therapies aimed at retarding the progression of vascular calcification. One study showed that agents that limit the absorption of phosphate from food (phosphate binders) slow the progression of vascular calcification, and as a result, treatments emphasize phosphate control through diet and phosphate binders. Other studies have shown that the use of statins, to lower LDL cholesterol levels may reduce the progression of coronary calcification in non-ESRD patients, but data from ESRD are lacking. While these treatments have been helpful, the improvements in patients' outcomes have not been overwhelming positive.
This proposed study is not the first to study the use of bisphosphonates on vascular calcification. Repeated studies have shown impressive reduction in calcification rates in several animal models, which begs the question, how will bisphosphonates fare in human subjects? Preliminary research has begun, but clearly an expansive trial on humans is needed to explore the use of a promising therapy. Our study hopes to provide insight into this area of cardiovascular research.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Ontario
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Kingston、Ontario、カナダ、K7L 2V7
- Kingston General Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 18 years of age
- receiving maintenance renal replacement therapy for less than 12 months
- incident patients starting renal replacement therapy for the first time
Exclusion Criteria:
- active vasculitis
- severe hypocalcemia
- previous adverse side effect to bisphosphonate use
- current use of corticosteroids
- weight greater than 300 pounds
- pregnancy
- not expected to survive greater than one year
- expected to discontinue renal replacement therapy during the study period or recover renal function
- evidence of adynamic bone disease
- current bisphosphonate use
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：1
Arm #1 will include patients randomized to receive bisphosphonate therapy for 24 months.
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35mg given orally once weekly for 24 months
他の名前：
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プラセボコンパレーター：2
Arm #2 will include patients randomized to receive placebo therapy for 24 months
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identical placebo pill once weekly for 24 months
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Absolute change in coronary artery calcification score (CaSc) from baseline to study completion.
時間枠：24 months
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24 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change in bone density score (wrist/hip) as calculated by Ct scanning method, # fractures, MI, Stroke, amputation/surgery for peripheral revascularization.
時間枠：24 months
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24 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Karen E Yeates, Dr、Queen's University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
慢性腎臓病の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ