Computer Guided Doing of Tacrolimus in Renal Transplantation (OPTIMAL)
Prospective Testing of Pharmacokinetic Population Models for Dosing of Transplanted Patients
Dosing of tacrolimus is challenging due to the large inter-individual variation in its pharmacokinetics. The investigators have developed a pharmacokinetics population model that can be used to estimate individual doses of tacrolimus in renal transplant recipients. The model will be prospective tested in a randomized clinical trial.
The hypothesis is that the computer model is superior to experienced transplant physicians in reaching and keeping the patients in the target range of tacrolimus.
調査の概要
詳細な説明
Patients will be randomized to either computer or standard dosing strategies at time of transplantation or as early after transplantation as possible in case of deceased donor transplants.
For patients in the computer arm the model will calculate the dose with the highest probability to reach the specified concentration target.
For all concentrations a predictive error will be calculated and this will be the primary endpoint that the statistics will be calculated on.
All patients will be followed for between 8 to 12 weeks post-transplant, according to center praxis.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Oslo、ノルウェー、0424
- Olso university hospital - Rikshospitalet
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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:
- renal transplant recipients using tacrolimus as part of their immunosuppression
- above 18 years
- signed informed consent
Exclusion Criteria:
- no specific
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：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 |
|---|---|
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実験的：Computer dosed
Patients for which the computer model will calculate the individual doses
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Pharmacokinetic population model for individual dose estimations of tacrolimus based on concentrations measurements and inclusion of relevant covariates
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アクティブコンパレータ：Control
Patients which will get their tacrolimus doses determined by experience transplant physicians
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Tacrolimus dose determination according to trough concentrations and standard TDM at the clinic
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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 |
|---|---|---|
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Predictive error (Cpred-Cobs)
時間枠：8 to 12 weeks
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Predictive error will be calculated as the computer predicted concentration minus the measured concentration over the first 8 to 12 weeks post-transplant in the computer group.
The calculations will be binned into weekly assessments.
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8 to 12 weeks
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Reaching the target concentration
時間枠：8 to 12 weeks post-transplant
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In each arm the deviation of the observed concentration front he preset target concentration will be calculated for each measured concentration.
The deviations will be compared between the two arms.
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8 to 12 weeks post-transplant
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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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Influence of CYP3A5 genotyping
時間枠：8 to 12 weeks post-transplant
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The model will be run without any information about patients CYP3A5 genotype as this is not clinical praxis at our center yet.
All patients will however be genotyped after the study and a model including this covariate will be used to recalculate the data and see if this model is superior to the simple model, primary by comparing predictive errors in the computer arm.
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8 to 12 weeks post-transplant
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協力者と研究者
捜査官
- スタディチェア：Anders Åsberg, PhD、OUS-Rikshospitalet and University of Oslo
出版物と役立つリンク
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
本研究に関する用語
その他の研究ID番号
- OPTIMAL-13
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。
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