Pilot Trial on Immunosuppression Modulation to Increase SARS-CoV-2 Vaccine Response in Kidney Transplant Recipients (BOOST_TX_SubA)
Pilot Trial on Immunosuppression Modulation in Kidney Transplant Recipients Without SARS-CoV-2 Spike Protein Antibodies Following Full Vaccination
Mycophenolate has been identified as risk factor for non-response to SARS-CoV-2 vaccination in kidney transplant recipients. Safety and efficacy of temporarily stopping of mycophenolate (or azathioprine) to increase vaccine response has not been established.
This is a non-randomized, controlled pilot study including up to 40 kidney transplant recipients not responding to at least three previous SARS-CoV-2 vaccine doses. Mycophenolate or azathioprine will be stopped for two weeks peri-vaccination starting one week before vaccination until one week after vaccination. Allocation to mycophenoalte or azathioprine discontinuation arm will be based on an overall risk assessment by the transplant physician and patient preference. Patients not stopping mycophenolate or azathioprine will serve as control group.
調査の概要
状態
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
-
-
-
Vienna、オーストリア、1090
- Medical University of Vienna
-
-
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:
- Patient has received a kidney transplantation
- > 18 years of age
- No SARS-CoV-2 spike protein antibodies four weeks after at least three previous vaccine doses
- Maintenance immunosuppression with mycophenolate or azathioprine
Exclusion Criteria:
- acute illness with fever
- Prior documented infection with SARS-CoV-2
- triple anticoagulation therapy
- Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
- Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures
- Subject is pregnant or breast feeding
- SARS-CoV-2 spike protein antibodies four weeks after the 3rd last vaccination > 0.8 BAU/mL
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：並列代入
- 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：Immunosuppression reduction
Participants stop mycophenolate or azathioprine for two weeks peri-vaccination.
Treatment is stopped on week before vaccination and only restarted one week after vaccination
|
participants stop mycophenolate or azathioprine one week before additional vaccine dose.
Overall medication is stopped for two weeks.
|
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アクティブコンパレータ：No immunosuppression reduction
no alterations to immunosuppression
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participants do not alter immunosuppresion
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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 |
|---|---|---|
|
Seroconversion at 4 weeks
時間枠：4 weeks
|
Number of patients developing SARS-CoV-2 antibodies at 4 weeks after vaccination
|
4 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Seroconversion at 7 days
時間枠：7 days
|
Number of patients developing SARS-CoV-2 antibodies at 7 days after vaccination
|
7 days
|
|
Antibody levels at 4 weeks
時間枠：4 weeks
|
SARS-CoV-2 antibody levels at 4 weeks after vaccination
|
4 weeks
|
|
Donor specific antibodies
時間枠：4 weeks
|
Donor specific antibodies at 4 weeks after mycophenolate / azathioprine pausing
|
4 weeks
|
|
Donor-derived cell free DNA
時間枠：4 weeks
|
Donor-derived at 4 weeks after mycophenolate / azathioprine pausing
|
4 weeks
|
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Creatinine levels
時間枠：4 weeks
|
Creatinine levels at 4 weeks after mycophenolate / azathioprine pausing
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4 weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (予想される)
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
その他の研究ID番号
- BOOST_TX_SubA
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
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。