Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation (NEWHOPE)
A Single-center, Non-randomized, Uncontrolled Pilot Study on Hypothermic Machine Perfusion With Omnisol Preservation Solution of Deceased Donor Kidneys Prior to Transplantation
Insufficient availability of organs from brain dead (DBD) and living donors has necessitated increased use of less than optimal organs from donation after cardiac death (DCD) or from extended criteria donors. Preservation of DCD organs using the current clinically applied preservation solutions is associated with up to 73% incidence of delayed graft function, highlighting the need for new preservation solutions designed to improve early graft function.
Omnisol is expected to result in equivalent or improved kidney preservation as compared to currently marketed organ preservation solutions used for HMP.
調査の概要
状態
詳細な説明
Omnisol organ preservation solution was developed to improve kidney transplant outcomes. It is an extracellular-type solution containing the synthetic colloid polyethylene glycol (PEG) and several impermeants for optimal osmotic pressure. It further contains multiple buffering agents for the prevention of intracellular acidosis, antioxidants for the minimization of ROS-induced injury and amino acids and other substrates for supporting the cell metabolism during hypothermic machine perfusion (HMP) as well as the provision of substrates for regeneration of high-energy phosphate compounds during graft reperfusion.
Continuous HMP using the XVIVO Kidney Assist Transport is routinely used for deceased donor kidney preservation in the Netherlands.
This is a single-center, non-randomized, uncontrolled, open-label first-in-human clinical investigation evaluating Omnisol as an organ preservation solution for continuous HMP of deceased donor kidneys before transplantation.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Benedict Doorschodt, MD
- 電話番号：+31 6 54658420
- メール：bd@vivalyx.com
研究場所
-
-
-
Rotterdam、オランダ、3015
- 募集
- Erasmus Medical Center
-
コンタクト：
- Robert Minnee, MD PhD
- 電話番号：+31-10-70 31149
- メール：r.minnee@erasmusmc.nl
-
主任研究者：
- Robert Minee
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion for donor:
- Donor age > 18 years
- Brain Death (DBD) or Circulatory Death < 50 years (DCD<50)
- Accepted for transplantation according to local criteria
Inclusion for recipient:
- Male or female, age > 18 years
- Able and willing to comply with all study requirements (in opinion of investigator or deputy)
General inclusion criteria applicable to kidney transplantation:
- Listed for renal transplantation due to end stage renal disease on the Eurotransplant (ET) list
- Fit to proceed with kidney transplantation (in opinion of investigator or deputy)
Exclusion for donor:
- Donor kidneys accepted as a pair for dual transplant
- Circulatory Death ≥ 50 years (DCD 50+)
- Participation in an investigational study likely to affect interpretation of the trial data
Exclusion for recipient:
- General exclusion criteria applicable to kidney transplantation
- Breast-feeding or pregnant, as confirmed by pregnancy test or blood test, or plans to become pregnant over the study period
- Participation in an investigational study likely to affect interpretation of the trial data
- Mental disabilities that may affect the understanding of the study requirements including the ability to adhere to medication regime (in opinion of investigator or deputy)
- Undergoing living donor kidney transplantation
- Undergoing dual kidney transplantation
- Undergoing transplantation of other organ(s) in addition to the kidney
- Highly immunized patients with vPRA > 85% (as confirmed by routine cross-matching test)
- Other substantial risk of transplant not proceeding (in opinion of investigator or deputy)
- Other significant disease or disorder which, in the opinion of the Investigator, may: (i) put the participant at risk by participating in the study; (ii) influence the result of the study; (iii) affect the participant's ability to participate in the study
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：なし
- 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：Hypothermic machine perfusion with Omnisol
Prior to transplantation, kidneys from deceased donors will undergo continuous nonoxygenated HMP with Omnisol using the XVIVO Kidney Assist Transport.
|
Omnisol for HMP of deceased donor kidneys
|
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 |
|---|---|---|
|
Incidence of Delayed Graft Function
時間枠：Within 7 days post-transplantation.
|
Incidence of delayed graft function, defined as the need for dialysis within the first week after transplantation, excluding one-time dialysis for hyperkalemia or volume overload.
|
Within 7 days post-transplantation.
|
|
Graft Survival
時間枠：30 days post-transplantation.
|
30-day graft survival (censored and uncensored for recipient death).
|
30 days post-transplantation.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Graft Survival
時間枠：3, 6 and 12 months post-transplantation.
|
Graft survival (censored and uncensored for recipient death).
|
3, 6 and 12 months post-transplantation.
|
|
Recipient survival
時間枠：30 days, 3, 6 and 12 months post-transplantation.
|
Rate of recipient survival.
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30 days, 3, 6 and 12 months post-transplantation.
|
|
Kidney Graft Function Assessed by eGFR
時間枠：30 days, 3, 6 and 12 months post-transplantation.
|
Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula.
|
30 days, 3, 6 and 12 months post-transplantation.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- OMNISOL_HMP_NL
- NL-OMON57467 (その他の識別子：Overview of Medical Research in the Netherlands (OMON))
- NL87460.000.24 (その他の識別子：The Central Committee on Research Involving Human Subjects (CCMO))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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