Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
2015年6月30日 更新者：Veloxis Pharmaceuticals
Ph 2 Double-blind, Double-dummy, Multicenter, Prospective, Rand Study of PK of LCP-Tacro™ Tablets Once Daily, Compared to Prograf® Caps, Twice Daily, for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients
The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.
調査の概要
詳細な説明
This is a 2-arm , parallel group, prospective, double-blind, double-dummy, multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily in comparison to Prograf capsules twice-daily after kidney transplantation.
研究の種類
介入
入学 (実際)
36
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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San Diego、California、アメリカ、92123
- Clinical Investigative Site 000015
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San Francisco、California、アメリカ、94115
- Clinical Investigative Site 000012
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Colorado
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Aurora、Colorado、アメリカ、80045
- Clinical Investigative Site 00004
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Florida
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Tampa、Florida、アメリカ、33606
- Clinical Investigative Site 000002
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Kentucky
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Lexington、Kentucky、アメリカ、40536-0293
- Clinical Investigative Site 000005
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- Clinical Investigative Site 000009
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New Jersey
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Livingston、New Jersey、アメリカ、07039
- Clinical Investigative Site 000010
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New York
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Buffalo、New York、アメリカ、14215
- Clinical Investigative Site 000011
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New York、New York、アメリカ、10016
- Clinical Investigative Site 00006
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Ohio
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Cleveland、Ohio、アメリカ、44095
- Clinical Investigative Site 00008
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Clinical Investigative Site 00003
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Texas
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Dallas、Texas、アメリカ、75246
- Clinical Investigative Site 000013
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Virginia
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Charlottesville、Virginia、アメリカ、22903
- Clinical Investigative Site 00001
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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
就学可能な年齢
18年～70年 (大人、高齢者)
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
- Give written consent
- Male and female subjects between the ages of 18 and 70 years, inclusive
- Must be receiving primary or secondary renal allograft from a deceased donor or non- HLA identical living donor
- WOCBP must have a negative pregnancy test
- Must have negative cross-match test and be ABO-compatible
- Must be able to swallow tablets and capsules
Exclusion criteria
- Recipients of any previous nonrenal or concurrent transplant
- Have panel reactive antibody >50%
- Any condition that may affect study drug absorption BMI <18 kg/m2 or > 45 kg/m2
- History of alcohol abuse with less than 6 months of sobriety
- History of recreational drug abuse with less than 6 months of documented abstinence
- Screening 12-lead ECG demonstrating CS abnormalities (including QTc prolongation)
- WOCBP and are either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test
- Subjects (male or female) with reproductive potential who are unwilling/unable to use a double-barrier method
- Oral temperature (prior to study drug dosing) of 38.0ºC or higher
- CS active infections (eg, those requiring hospitalization, or as judged by the Investigator)
- Known hereditary immunodeficiency
- Malignancies or with a history of malignancies (within the last 5 years) with the exception of local, noninvasive, fully excised cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ
- Expect to receive within 2 months after randomization, or have received within 3 months prior to screening, any of the following: sirolimus, everolimus, belatacept, or cyclophosphamide
- Any psychiatric or medical condition that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- Clinically symptomatic CHF or documented EJF of less than 45%
- Significant COPD, pulmonary restrictive disease or significant pulmonary hypertension
- Enrolled in another investigational drug or device study, or who are less than 30 days since discontinuing
- Laboratory variables that are abnormal (outside laboratory reference range) and CS
- Positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV) antibody (HCV Ab)
- Subjects who have had primary focal segmental glomerulosclerosis
- Donor parameters must not include any of the following known conditions:
Donor with positive serological test result for HIV-1, HBV or HCV Donor with history of malignant disease (current or historical) Cold ischemia time >30 hours Non-heart-beating donor
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：LCP-Tacro
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
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Tacrolimus
他の名前：
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アクティブコンパレータ：Prograf
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
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Tacrolimus
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
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
時間枠：1 days
|
The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
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1 days
|
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Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
時間枠：14 days
|
The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
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14 days
|
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Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
時間枠：28 days
|
The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients.
Samples were collected from 0 to 24 hours post dose.
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28 days
|
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Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
時間枠：1 days
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The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.
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1 days
|
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Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
時間枠：14 days
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The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.
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14 days
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Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
時間枠：28 days
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The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.
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28 days
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Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
時間枠：1 days
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The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.
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1 days
|
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Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
時間枠：14 days
|
The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.
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14 days
|
|
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
時間枠：28 days
|
The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.
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28 days
|
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Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
時間枠：14 days
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The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.
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14 days
|
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Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
時間枠：28 days
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The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.
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28 days
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.
時間枠：14 days
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At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
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14 days
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Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.
時間枠：28 days
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At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Day 28.
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28 days
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Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.
時間枠：14 days
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At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
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14 days
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Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.
時間枠：28 days
|
At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 28.
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28 days
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Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.
時間枠：30 days
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The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.
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30 days
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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。
スポンサー
捜査官
- スタディディレクター：William Polvino, MD、Veloxis Pharmaceuticals
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
2012年11月1日
一次修了 (実際)
2013年3月1日
研究の完了 (実際)
2013年5月1日
試験登録日
最初に提出
2012年8月14日
QC基準を満たした最初の提出物
2012年8月14日
最初の投稿 (見積もり)
2012年8月16日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年7月7日
QC基準を満たした最後の更新が送信されました
2015年6月30日
最終確認日
2015年6月1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。