Safety of Immunosuppression Minimization in Children and Adolescents After Kidney Transplantation
Immunosuppression Minimization to Single Drug Therapy With Sirolimus (Rapamune) in Pediatric Transplantation
調査の概要
詳細な説明
Improvements in surgical techniques, donor selection, immunosuppression practices, and the enhanced experience of specialized pediatric transplant teams have all led to marked improvements in patient and kidney graft survival in infants and young children Long-term graft survival rates decrease in adolescents 11 to 17 years of age. Several studies have suggested this decrease may be the result of noncompliance with immunosuppressive medications in this age group. Therefore, protocols that minimize the use of immunosuppressive medications, while retaining kidney function are necessary for improving graft and patient survival in children. The purpose of this study is to determine the safety of sirolimus monotherapy for long-term immunosuppression in children and adolescents after kidney transplantation.
This study will enroll 10 participants who previously completed the CCTPT-PC01 study. The accrual period is scheduled for 12 months. The study follow-up period will last 96 weeks. Patients from the CCTPT-PC01 study have been maintained on sirolimus and mycophenolate mofetil (MMF) since 2-3 months post transplant. Enrolled participants receiving (MMF) or Azathioprine at study entry will have their doses withdrawn gradually over a period of 6 months. Dosage will be reduced by 25% initially and by 25% every 2 months resulting in complete withdrawal by 6 months.
This study will consist of 11 study visits after screening and study entry. Study visits will occur at weeks 1, 8, 16, 24, 32, 40, 48, 60, 72, 84, and 96. A physical exam, vital signs, sirolimus levels, as well as blood and urine collection will occur at all visits. A renal biopsy will be performed at week 96.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
California
-
Madera、California、アメリカ
- Children's Hospital of Central California
-
San Francisco、California、アメリカ
- UCSF Children's Hospital
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ
- Children's Hospital, Boston
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ
- Children's Hospital, Philadelphia
-
-
Washington
-
Seattle、Washington、アメリカ
- Children's Hospital and Regional Medical Center, Seattle
-
-
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:
- Participant and/or parent guardian able to understand and willing to provide informed consent
- Previously enrolled and completed the CCTPT-PC01 study and within the 36 months post-completion timeframe prior to study entry
- Currently receiving sirolimus and MMF or azathioprine therapy
- No history of acute rejection episodes
- No evidence of acute or chronic rejection on the 24 month CCTPT-PC01 protocol biopsy or any subsequent biopsy obtained after that time prior to study entry
- PRA (Class I and II) less than 5% at study entry
- No evidence of donor specific antibody at study entry
- Stable renal function with GFR greater than 60 cc/min 1.73M^2 using the Schwartz calculated method
- A negative pregnancy test for female participants of childbearing potential at study entry
- Agreement by female and male participants to use FDA approved methods of contraception.
Exclusion Criteria:
- Total lymphocyte count less than 400 mm^3
- Acute or chronic infection at study entry
- Treatment with investigational drug within 1 month prior to study entry
- Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the study
- History of allergic reaction to Iodine GFR assay
- History of malignancy within the past 12 months
- Inability or unwillingness to give informed consent or comply with the study protocol
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：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：1
Participants who have been maintained on MMF at study entry will start the study on 600 mg/m2 MMF orally daily. Participants who have been maintained on Azathioprine due to MMF intolerance will receive 1 mg/kg Azathioprine orally daily. Participants will continue receiving sirolimus throughout the study. However, MMF or Azathioprine will be withdrawn gradually over a period of at least 6 months. Dosage will be reduced by 25% initially and by 25% every subsequent 2 months resulting in complete withdrawal by 6 months. |
Oral tablets or liquid taken every 12 hours.
Dosage adjusted to attain target trough levels of 8-12 ng/mL.
Participants who have maintained such levels at study entry on once daily dosage will be permitted to continue on once daily dosing.
他の名前：
600 mg/m2 MMF taken orally daily or Azathioprine orally daily.
Dosage of Azathioprine is dependent on weight.
MMF or Azathioprine will be reduced by 25% initially and by 25% every 2 months resulting in complete withdrawal by 6 months.
|
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 |
|---|---|
|
Per-person incidence of acute rejection episodes and death or graft loss
時間枠：Throughout study
|
Throughout study
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Incidence of chronic allograft dysfunction
時間枠：Throughout study
|
Throughout study
|
|
Incidence of sub-clinical rejection
時間枠：Throughout study
|
Throughout study
|
|
Incidence of hospitalizations
時間枠：Throughout study
|
Throughout study
|
|
Incidence of surgical complications
時間枠：Throughout study
|
Throughout study
|
|
Resumption of MMF or other therapy
時間枠：Throughout study
|
Throughout study
|
|
Incidence, severity, and treatment of anemia, hypertension, hyperlipidemia, proteinuria, thrombocytopenia, and leukopenia
時間枠：Throughout study
|
Throughout study
|
|
Incidence, severity, and treatment of opportunistic infections
時間枠：Throughout study
|
Throughout study
|
|
Incidence of biopsy proven PTLD
時間枠：Throughout study
|
Throughout study
|
|
Renal function assessed by measured GFR
時間枠：At baseline, week 48 and week 96
|
At baseline, week 48 and week 96
|
|
Development of donor-specific or non-specific anti-HLA antibodies
時間枠：Throughout study
|
Throughout study
|
|
Evolution of immune response in cellular, humoral, and molecular assays from baseline through week 96
時間枠：Throughout study
|
Throughout study
|
協力者と研究者
捜査官
- スタディチェア：William H. Harmon, MD、Boston Children's Hospital
出版物と役立つリンク
一般刊行物
- Watson CJ, Bradley JA, Friend PJ, Firth J, Taylor CJ, Bradley JR, Smith KG, Thiru S, Jamieson NV, Hale G, Waldmann H, Calne R. Alemtuzumab (CAMPATH 1H) induction therapy in cadaveric kidney transplantation--efficacy and safety at five years. Am J Transplant. 2005 Jun;5(6):1347-53. doi: 10.1111/j.1600-6143.2005.00822.x.
- McDonald RA, Smith JM, Ho M, Lindblad R, Ikle D, Grimm P, Wyatt R, Arar M, Liereman D, Bridges N, Harmon W; CCTPT Study Group. Incidence of PTLD in pediatric renal transplant recipients receiving basiliximab, calcineurin inhibitor, sirolimus and steroids. Am J Transplant. 2008 May;8(5):984-9. doi: 10.1111/j.1600-6143.2008.02167.x.
便利なリンク
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。
Sirolimusの臨床試験
-
Instituto Nacional de Cardiologia Ignacio Chavez募集
-
Scitech Produtos Medicos Ltdaわからない
-
Robbert J de Winterわからない
-
Biotronik (Beijing) Medical Device Ltd.Biotronik AG招待による登録
-
Meril Life Sciences Pvt. Ltd.Lifecare Institute of Medical Sciences and Research Ahmedabad Gujarat India完了
-
Biotronik, Inc.積極的、募集していない心筋虚血 | 冠動脈疾患 | 狭心症 | 急性冠症候群 | 虚血性心疾患 | 動脈硬化、冠動脈アメリカ
-
Biotronik, Inc.Medstar Health Research Institute; Biotronik AG; Baim Institute for Clinical Research完了心筋虚血 | 冠動脈疾患 | 狭心症 | 急性冠症候群 | 虚血性心疾患 | 動脈硬化、冠動脈ベルギー, イスラエル, スペイン, 大韓民国, アメリカ, スイス, ドイツ, カナダ, オランダ, ハンガリー, デンマーク, ニュージーランド, オーストラリア