Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD)
2018年6月1日 更新者：AbbVie (prior sponsor, Abbott)
A Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric Subjects Ages 10 to 16 Years With Moderate to Severe Chronic Kidney Disease
Part 1: To determine the safety, tolerability, and pharmacokinetics of a single dose of 3 μg paricalcitol capsules in children ages 10 to 16 years with moderate to severe chronic kidney disease (CKD Stages 3 and 4).
Part 2: To determine the safety and efficacy of paricalcitol capsules as compared to placebo in decreasing serum intact parathyroid hormone (iPTH) in children ages 10 to 16 years with moderate to severe chronic kidney disease with an initial 12 weeks of double-blinded study drug followed by a minimum of 12 weeks of open-label active drug.
調査の概要
状態
状態
完了
条件
条件
介入・治療
介入・治療
詳細な説明
The study consists of two parts.
Part 1 is an open-label single-dose, non-fasting, multicenter study to evaluate the pharmacokinetics (PK) of paricalcitol capsules in 12 children ages 10 to 16 years with CKD Stages 3 and 4. Part 2 of this study will be conducted as a 12 week randomized double-blind, placebo-controlled study, followed by 12 weeks open-label treatment.
Participants active or enrolled under amendment 5 will enter a follow-up period and have study visits every 4 weeks until the final participant reaches Week 24.
研究の種類
研究の種類
介入
入学 (実際)
入学
47
段階
段階
- フェーズ 3
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
10年～16年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Subject has chronic kidney disease Stage 3 or 4 as determined by estimated glomerular filtration rate (15 to 59 mL/min/1.73 m²) at Screening.
- Subject is not expected to begin dialysis for at least 6 months (in the opinion of the investigator).
For entry into the Washout Period (for subjects who are currently on a vitamin D receptor activator [VDRA] and need to complete a 2 to 4 week washout), the subject must satisfy the following criteria based on the Screening laboratory values:
- estimated glomerular filtration rate between 15 to 59 mL/min/1.73 m².
- iPTH measurement that is greater than or equal to 60 pg/mL (Stage 3 subjects) or greater than or equal to 90 pg/mL (Stage 4 subjects).
- An adjusted serum calcium value greater than or equal to 8.2 mg/dL (2.05 mmol/L) to less than or equal to 10.5 mg/dL (2.63 mmol/L).
- A serum phosphorus value greater than or equal to 2.0 mg/dL (0.65 mmol/L but less than or equal to 6.0 mg/dL (1.94 mmol/L).
For entry into the Treatment Phase (vitamin D receptor activator naïve subjects and those that have completed a 4 week washout), the subject must have:
- iPTH measurement that is greater than or equal to 75 pg/mL (Stage 3 subjects) or greater than or equal to 110 pg/mL (Stage 4 subjects).
- An adjusted serum calcium value greater than or equal to 8.4 mg/dL (2.10 mmol/L) but less than or equal to 10.2 mg/dL (2.55 mmol/L).
- A serum phosphorus value greater than or equal to 2.5 mg/dL (0.81 mmol/L) but less than or equal to 5.8 mg/dL (1.87 mmol/L).
- Must have 25-hydroxyvitamin D levels ≥ 30 ng/mL prior to washout, if not VDRA naïve, or treatment in Part II of the study.
Exclusion Criteria:
- All subjects that have had a small bowel transplant will be excluded from the study.
- Subject has had acute kidney failure within 12 weeks of the Screening Phase (defined as an acute rise in serum creatinine).
- Subject has had symptomatic or significant hypocalcemia requiring active vitamin D therapy (for example, calcitriol, paricalcitol, doxercalciferol or alfacalcidol) within 6 months prior to the Screening Phase.
- Subject has a history of active kidney stones (6 months prior to screening).
- Subject has chronic gastrointestinal disease, which in the investigator's opinion may cause significant gastrointestinal malabsorption.
- Subject is taking maintenance calcitonin, bisphosphonates, cinacalcet, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 weeks prior to treatment.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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
アーム数
3
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：Part 1: Paricalcitol
Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
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Paricalcitol capsules taken with water.
他の名前：
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プラセボコンパレーター：Part 2: Placebo
Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase.
From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week.
Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
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Paricalcitol capsules taken with water.
他の名前：
Placebo capsules taken with water
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実験的：Part 2: Paricalcitol
Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24).
The initial dose of paricalcitol was 1 µg TIW.
Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
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Paricalcitol capsules taken with water.
他の名前：
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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
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Part 1: Paricalcitol Maximum Observed Plasma Concentration (Cmax)
時間枠：Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.
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Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.
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Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
時間枠：Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.
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Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.
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Part 2: Percentage of Participants Achieving Two Consecutive Reductions at Least 30% From Baseline in iPTH
時間枠：12-week double-blind treatment period
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The primary efficacy endpoint was the percentage of participants who achieved two consecutive ≥ 30% reductions from baseline in intact parathyroid hormone (iPTH) levels during the 12 week double-blind portion of the study regardless of CKD stage.
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12-week double-blind treatment period
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Part 2: Percentage of Participants Achieving a Final iPTH Within KDOQI Target Ranges
時間枠：Week 12
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The Kidney Disease Outcomes Quality Initiatives (KDOQI) Pediatric Subcommittee on Practice Guidelines for Bone Metabolism and Disease in Children with CKD target range for intact parathyroid hormone (iPTH) is as follows:: CKD Stage 3: 35 - 69 pg/mL; CKD Stage 4: 70 - 110 pg/mL. |
Week 12
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Part 2: Change From Baseline in iPTH to Each Post-baseline Visit
時間枠：Baseline and Weeks 2, 4, 8 and 12
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Baseline and Weeks 2, 4, 8 and 12
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Part 2: Percentage of Participants Achieving Final Calcium Levels Within KDOQI Target Ranges
時間枠：Week 12
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KDOQI recommends serum calcium is maintained within age appropriate normal ranges: Age 6 - 12: 9.4 - 10.2 mg/dL (2.35 - 2.55 mmol/L); Age 13 - 20: 8.8 - 10.2 mg/dL (2.20 - 2.55 mmol/L). |
Week 12
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Part 2: Percentage of Participants Achieving Final Phosphorus Levels Within KDOQI Target Ranges
時間枠：Week 12
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The KDOQI target ranges of serum phosphorus are to maintain at or above age appropriate lower limits and no higher than the age-appropriate upper limits: Age 6 - 12: 3.6 - 5.8 mg/dL (1.16 - 1.87 mmol/L); Age 13 - 20: 2.3 - 4.5 mg/dL (0.74 - 1.45 mmol/L). |
Week 12
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Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR)
時間枠：Baseline and Weeks 4, 8 and 12
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The mean change from Baseline in FMV UACR on a log scale to each post baseline visit.
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Baseline and Weeks 4, 8 and 12
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
捜査官
- スタディディレクター：Deepa Chand, MD、AbbVie
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
研究開始
2010年2月1日
一次修了 (実際)
一次修了
2014年5月1日
研究の完了 (実際)
研究の完了
2014年12月1日
試験登録日
最初に提出
最初に提出
2009年11月13日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2009年11月20日
最初の投稿 (見積もり)
最初の投稿
2009年11月24日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2018年7月2日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2018年6月1日
最終確認日
最終確認日
2017年2月1日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- M10-149
- 2010-019439-37 (EudraCT番号)
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。