腎移植を受けた成人の抗体媒介性拒絶反応（AMR）患者におけるフェルザルタマブ点滴の長期安全性と効果に関する研究
299AR301フェルザルタマブ試験からの参加者を対象とした非盲検長期延長試験
In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and then developed antibody-mediated rejection (AMR) or microvascular inflammation (MVI). AMR happens when the body's immune system creates donor-specific antibodies (DSAs) that attack the transplanted kidney. In late AMR, this typically happens more than 6 months after the kidney transplant. MVI is a condition where the small blood vessels in the transplanted kidney become inflamed. MVI can happen with or without DSAs. Both AMR and MVI can cause the transplanted kidney to stop working properly.
Two earlier studies looked at felzartamab in kidney transplant recipients. Study 299AR301 (TRANSCEND) (NCT06685757) included participants with AMR. Study 299AR201 (TRANSPIRE) (NCT07219043) included participants with MVI.
This study, 299AR302-299AR301 LTE, is a long-term extension of both of these "parent" studies. Participants who join this study will have the opportunity to receive felzartamab for up to 4 more years after completing their parent study.
The goal of this study is to learn more about the long-term safety and effects of felzartamab in people with kidney transplants. This study is part of a group of studies looking at long-term felzartamab use in people with organ transplants. This study is a substudy of the main study 299AR302.
The main question researchers will answer relate to safety. Namely, how many participants have adverse events during the study and how lab test results change over time. Adverse events are health problems that may or may not be caused by the study drug.
Researchers will perform kidney biopsies to track kidney health. Researchers will also study how felzartamab affects kidney inflammation, kidney function, immune activity, and overall health.
The study will be done as follows:
- Participants who complete the final visit of the treatment period in one of the parent studies can enroll in this study. This includes participants who stopped receiving felzartamab early but still attended their final visits.
- Participants who did not stop receiving felzartamab in their parent study will continue to receive felzartamab for up to 4 more years in this study. Participants may also stop felzartamab during this study at any time.
- Participants who stopped receiving felzartamab in their parent study will only attend study visits for health monitoring- they will not receive felzartamab.
- Felzartamab will be given as an intravenous (IV) infusion, which is a slow injection into a vein using a needle.
- Participants receiving felzartamab may have up to 27 study visits over 200 weeks with an additional safety follow-up visit after their final dose.
- Participants who are not receiving felzartamab may have up to 9 study visits over 200 weeks.
調査の概要
詳細な説明
The primary objective of this study is to evaluate the long-term safety of felzartamab. The secondary objectives of this study are to describe the ongoing efficacy of felzartamab on biopsy-proven histologic response (BPHR), microvascular inflammation (MVI) and graft function; and to evaluate pharmacokinetics (PK) and immunogenicity of felzartamab.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90048
- Cedars-Sinai Medical Center
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Los Angeles、California、アメリカ、90033
- Keck Medical Center of USC
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Los Angeles、California、アメリカ、90095
- UCLA College of Medicine
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San Francisco、California、アメリカ、94115
- California Pacific Medical Center (Sutter Health)
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
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Missouri
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St Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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Nebraska
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Omaha、Nebraska、アメリカ、68198-3040
- University of Nebraska Medical Center (UNMC) - Nebraska Medicine - Nebraska Medical Center
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New Jersey
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West Orange、New Jersey、アメリカ、07039
- Cooperman Barnabas Medical Center
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic
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Columbus、Ohio、アメリカ、43210
- The Ohio State University
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Penn Medicine - Hospital of the University of Pennsylvania
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Virginia
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Richmond、Virginia、アメリカ、23298
- Virginia Commonwealth University
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Washington
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Seattle、Washington、アメリカ、98195
- University of Washington Medical Center
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin
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British Columbia
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Vancouver、British Columbia、カナダ、V6Z1Y6
- Providence Health Care - St. Paul's Hospital
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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
Key Inclusion Criteria:
-
Have completed the parent study Week 52 visit or will be completing Week 52 visit procedures (for participants who sign consent before reaching the Week 52 visit).
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Have received at least one dose of felzartamab in the parent studies, and had the following disposition status in the parent study:
- Ongoing Treatment: Did not discontinue felzartamab treatment in the parent study and received a dose at the Week 44 visit.
- Treatment Interrupted: Did not discontinue felzartamab treatment in the parent study and did not receive a dose at the Week 44 visit.
- Off Treatment, On Study: Discontinued felzartamab treatment in the parent study and were not withdrawn from the study.
Participants who discontinued study treatment prior to receiving any doses of felzartamab in the parent study (i.e., those in the placebo group who discontinued before receiving felzartamab) are not eligible for enrollment in this substudy.
- For participants enrolling into this study who have not discontinued felzartamab treatment in the parent study only: The Investigator has determined that the participant could benefit from continued felzartamab treatment.
Key Exclusion Criteria:
- Met a treatment discontinuation criterion in the parent study but treatment was not discontinued (for example, because the criterion was met after the last dose of felzartamab in the parent study).
Note: Other protocol-defined inclusion/exclusion criteria apply.
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：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 |
|---|---|
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実験的：Felzartamab: Long-Term Extension Treatment
Participants will receive multiple IV doses of felzartamab. |
Administered IV
他の名前：
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実験的：Felzartamab: Off-Treatment Observation
Participants who were off treatment but still continued participating in the respective parent study at the time of enrollment into the LTE or who have discontinued felzatamab treatment after receiving one or more doses in this substudy will be encouraged to continue being followed off-treatment. |
Administered IV
他の名前：
|
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 |
|---|---|
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有害事象（AE）、重篤な有害事象（SAE）、および特別関心事象（AESI）を経験した参加者の数
時間枠：研究薬の初回投与から研究追跡終了まで（最長204週間）
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研究薬の初回投与から研究追跡終了まで（最長204週間）
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有害事象により治療を中止した参加者数
時間枠：研究薬の初回投与から研究フォローアップ終了まで（最大204週間）
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研究薬の初回投与から研究フォローアップ終了まで（最大204週間）
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臨床的に有意な臨床検査、バイタルサイン、心電図（ECG）異常を有する参加者数
時間枠：試験薬の初回投与から試験終了時点まで（最大200週間）
|
試験薬の初回投与から試験終了時点まで（最大200週間）
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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生検で証明された組織学的寛解（BPHR）を達成した参加者の割合
時間枠：最大200週間
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最大200週間
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微小血管炎症（MVI）スコア
時間枠：最大200週間
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最大200週間
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推定糸球体濾過率（eGFR）のベースラインからの変化
時間枠：ベースライン、200週目
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ベースライン、200週目
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全原因同種移植片喪失までの時間
時間枠：最長200週間
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最長200週間
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死亡または移植片喪失までの時間
時間枠：最長204週間
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最長204週間
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フェルザルタマブ血清濃度
時間枠：200週目に
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200週目に
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フェルザルタマブに対する抗薬物抗体（ADA）陽性参加者数
時間枠：200週目で
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200週目で
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Percentage of Participants Achieving an MVI Score of 0 by Each Biopsy Timepoint
時間枠：Up to Week 200
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Up to Week 200
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Change From Baseline in Proteinuria
時間枠：Baseline, Week 200
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Baseline, Week 200
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Medical Director、Biogen
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
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?
IPD プランの説明
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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
米国で製造され、米国から輸出された製品。
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。