Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients
A 12-month, Multicenter, Randomized, Open-label Non-inferiority Study of Renal Function and Efficacy Comparing Concentration-controlled Certican (1.5 mg/Day Starting Dose) With Reduced Neoral Dose Versus MMF With Standard Neoral Dose in de Novo Heart Transplant Recipients
This study will test the safety and efficacy of everolimus on heart transplant recipients.
This study is not recruiting in the United States.
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
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:
- Male or female cardiac recipients 18-65 years of age undergoing primary heart transplantation. The graft must be functional at the time of randomization.
- Calculated creatinine clearance (Cockroft-Gault) ≥ 50 mL/min at screening.
- Patients who have given written informed consent to participate in the study.
Exclusion Criteria:
Patients who are recipients of multiple solid organ transplants or have previously received organ transplants.
Patients who received any investigational drug or who have been treated with an immunosuppressive drug or treatment within 1 month prior to randomization Patients receiving induction therapy which is not standard per local practice Patients with donor greater than 60 years and/or with known donor coronary or heart disease at the time of transplant.
Donor heart cold ischemic time >6 hours. Patients with Panel Reactive Antibodies >20%. Patients who are recipients of ABO incompatible transplants Patients with platelet count <50,000/mm3 at the evaluation before randomization.
Presence of severe hypercholesterolemia (≥350 mg/dL; ≥9 mmol/L) or hypertriglyceridemia (≥750 mg/dL; ≥8.5 mmol/L) Patients with an absolute neutrophil count of ≤1,500/mm3 or white blood cell count of ≤4000/mm3 at baseline before surgery Patients with a history of significant coagulopathy or medical condition requiring long term anti-coagulation after transplantation (low dose aspirin treatment is allowed) Patients who are HIV-positive or Hepatitis C (PCR+ only) or B surface antigen positive. Laboratory results obtained within 6 months prior to study entry are acceptable.
Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C (PCR+ only) are excluded Patients with a known hypersensitivity to similar drugs and to the components of the formulations Patients being treated with terfenadine, astemizole, or cisapride. Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450 3A4.
Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma) Patients with clinically significant systemic infection Patients who are unable to take oral medication Existence of any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication, and/or the presence of severe diarrhea or active peptic ulcer Abnormal physical or laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the objectives of the study Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
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:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
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 |
---|
compare renal function
|
二次結果の測定
結果測定 |
---|
compare rates of acute rejection, efficacy and safety
|
協力者と研究者
スポンサー
捜査官
- スタディチェア:Basel Novartis Pharma AG、Basel Novartis Pharma AG
出版物と役立つリンク
一般刊行物
- Lehmkuhl et al., Transplantation, Volume 88, Number 1, July 15, 2009
- Vigano M, Dengler T, Mattei MF, Poncelet A, Vanhaecke J, Vermes E, Kleinloog R, Li Y, Gezahegen Y, Delgado JF; RAD A2411 Study Investigators. Lower incidence of cytomegalovirus infection with everolimus versus mycophenolate mofetil in de novo cardiac transplant recipients: a randomized, multicenter study. Transpl Infect Dis. 2010 Feb;12(1):23-30. doi: 10.1111/j.1399-3062.2009.00448.x. Epub 2009 Sep 9.
研究記録日
主要日程の研究
研究開始
一次修了 (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 (実際)
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。
心臓移植の臨床試験
-
Novartis Pharmaceuticals完了EC-MPS による治療に関心があり、コア研究の 12 か月の治療期間を無事に完了した患者 (de novo Heart Recipients)
エベロリムスの臨床試験
-
Concept Medical Inc.積極的、募集していない冠動脈疾患 | 糖尿病 | 急性冠症候群スイス, オーストラリア, 大韓民国, フランス, ベルギー, オランダ, イギリス, インド, オーストリア, バングラデシュ, ブラジル, チェコ, ドイツ, アイルランド, イタリア, マレーシア, メキシコ, ポーランド, シンガポール, スウェーデン, 台湾
-
National Taiwan University Hospitalわからない