A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
2026年6月2日 更新者：Takeda
A Double-Blind, Placebo-Controlled, Multicenter, Randomized, Phase 2 Trial to Evaluate the Safety and Efficacy of Mezagitamab (TAK-079) in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)
Antibody-mediated rejection (AMR) is a major cause of worsening kidney function after a kidney transplant (kidney allograft dysfunction) and can lead to kidney failure. AMR happens when the kidney recipient's immune system makes antibodies that attack the donor kidney. Antibodies are proteins made by the immune system to recognize foreign cells. Over time, this attack can damage kidney tissue and cause the transplant to fail. Because AMR can be serious, there is a need for treatments that are safe, work well, and are supported by good evidence.
The main aim of this study is to find out how safe mezagitamab is and how well adults with AMR tolerate it compared with placebo. A placebo looks like medicine but has no active ingredients. The study will also look at whether mezagitamab helps to control inflammation in the transplanted kidney and helps keep kidney function stable, compared with placebo.
Participants will be placed by chance in 1 of the 3 treatment groups in equal numbers. Two groups will receive mezagitamab in two different doses. One group will receive placebo. This means that out of every 3 participants, 2 will receive mezagitamab and 1 will receive placebo.
During the study, participants will visit their study clinic several times.
調査の概要
研究の種類
介入
入学 (推定)
36
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Takeda Contact
- 電話番号：+1-877-825-3327
- メール：medinfoUS@takeda.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Key inclusion criteria:
- The participant aged 18 to 80 years.
- The participant must have a biopsy-confirmed diagnosis of active or chronic active late AMR (defined as greater than [>] 6 month after kidney transplant) without concurrent definitive TCMR (Grade 1a and above) as defined by the 2022 Banff classification.
- Biopsy within 30 days prior to screening, or performed during screening period within protocol-defined window.
- If the participant has received treatment for rejection, then the repeat biopsy and donor specific antibody (DSA) testing must have been performed at least 6 weeks after stopping the treatment.
- The participant with either human leukocyte antigen (HLA) class I and/or II DSA.
- eGFR > 30 milliliters per minute per 1.73 square meters (mL/min/1.73m^2).
Key exclusion criteria:
- The participant has blood type A, B, AB, or O (ABO) incompatible transplant.
- The participant has a history of multiple organ transplants, including en bloc and dual kidney transplants.
- Participant likely to require renal replacement therapy within the subsequent 30 days.
- Participants who have received an anti-cluster of differentiation 38 (CD38) therapy in the last 1 year or have past history of failing to achieve AMR resolution despite treatment with an anti-CD38 therapy.
The participant has received any previous treatment with other immunosuppressant or immunomodulatory therapy:
a) Within 6 months of signing the informed consent form (ICF) as listed below:
- Complement system inhibitors (such as, eculizumab).
- Proteasome inhibitors (such as, bortezomib).
- Interleukin-6 (IL-6)/IL-6R antibody (such as, tocilizumab).
- Anti-cluster of differentiation 20 (CD20) antibody (such as, rituximab). b) Within 6 weeks of signing the ICF as listed below:
- Intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) or plasmapheresis
- The participant has active infection with hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Participant with serious infection within 2 weeks or with opportunistic infection within 2 months prior to signing ICF. Participant with active or untreated tuberculosis, or those with high suspicion of tuberculosis are also excluded.
- History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for adequately treated non-melanoma skin cancer, superficial bladder cancer, and curatively treated cervical carcinoma-in-situ.
Key Note: Other protocol specified inclusion and exclusion criteria apply.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm A: Mezagitamab + Placebo
Participants will receive mezagitamab up to Week 24, followed by placebo up to Week 48, followed by an observation period up to Week 70.
|
Mezagitamab subcutaneous (SC) injection.
他の名前：
Mezagitamab-matching placebo SC injection.
|
|
実験的：Arm B: Mezagitamab
Participants will receive mezagitamab up to Week 48, followed by an observation period up to Week 70.
|
Mezagitamab subcutaneous (SC) injection.
他の名前：
|
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アクティブコンパレータ：Arm C: Placebo
Participants will receive placebo up to Week 48, followed by an observation period up to Week 70.
|
Mezagitamab-matching placebo SC injection.
|
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 |
|---|---|---|
|
Arms A, B, and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
時間枠：Up to Week 70
|
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention.
TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational medicinal product (IMP).
|
Up to Week 70
|
|
Arms A, B, and C: Number of Participants With Related TEAEs
時間枠：Up to Week 70
|
A related AE is an AE that is considered related to the IMP.
Related TEAEs are defined as related AEs with start dates at the time of or following the first exposure to IMP.
|
Up to Week 70
|
|
Arms A, B, and C: Number of Participants With Serious Adverse Events (SAEs)
時間枠：Up to Week 70
|
An SAE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
|
Up to Week 70
|
|
Arms A, B, and C: Number of Participants With AEs of Special Interest
時間枠：Up to Week 70
|
AEs of special interest are AEs that are considered specific to the IMP.
|
Up to Week 70
|
|
Arms A, B, and C: Number of Participants With AE Leading to Treatment Discontinuation
時間枠：Up to Week 70
|
Up to Week 70
|
|
|
Arms A, B, and C: Number of Participants With Clinically Significant Abnormal Laboratory Test Results and Vital Signs
時間枠：Up to Week 70
|
Up to Week 70
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Arms A, B, and C: Percentage of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Weeks 24 and 48
時間枠：Weeks 24 and 48
|
Achievement of biopsy-proven histological resolution of AMR activity will be assessed by the 2022 Banff classification criteria.
The Banff 2022 Classification provides a standardized framework for evaluating kidney transplant biopsies using lesion scoring.
|
Weeks 24 and 48
|
|
Arms A, B, and C: Microvascular Inflammation (MVI) Score in Biopsy Samples at Weeks 24 and 48
時間枠：Weeks 24 and 48
|
MVI is an important marker of allograft loss and is defined as the sum of glomerulitis and peritubular capillaritis scores (g+ptc) on kidney histology.
|
Weeks 24 and 48
|
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Arms A, B, and C: Percentage of Participants Who Achieve a MVI Score of 0 at Weeks 24 and 48
時間枠：Weeks 24 and 48
|
Weeks 24 and 48
|
|
|
Arms A, B, and C: Change From Baseline in MVI score at Weeks 24 and 48
時間枠：Baseline, Weeks 24 and 48
|
Baseline, Weeks 24 and 48
|
|
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Arms A, B, and C: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Weeks 24, 48 and 70
時間枠：Baseline, Weeks 24, 48 and 70
|
eGFR is a measure of kidney function calculated from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
|
Baseline, Weeks 24, 48 and 70
|
|
Arms A, B, and C: Change From Baseline in Donor-Derived Cell-Free DNA (dd-cfDNA) at Weeks 24, 48 and 70
時間枠：Baseline, Weeks 24, 48 and 70
|
dd-cfDNA are DNA fragments released from injured donor cells.
It serves as a noninvasive, quantitative method that reflects allograft injury and is associated with AMR activity in kidney transplant recipients.
|
Baseline, Weeks 24, 48 and 70
|
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Arms A, B, and C: Change From Baseline in Urine Protein Creatinine Ratio (UPCR) at Weeks 24, 48 and 70
時間枠：Baseline, Weeks 24, 48 and 70
|
UPCR is a measure of protein excretion calculated from a urine sample, as the ratio of urine protein to creatinine, and used to assess kidney function.
|
Baseline, Weeks 24, 48 and 70
|
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Arm B: Percentage of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 70
時間枠：Week 70
|
Week 70
|
|
|
Arm B: MVI Score in Biopsy Samples at Week 70
時間枠：Week 70
|
Week 70
|
|
|
Arm B: Percentage of Participants Who Achieve a MVI Score of 0 at Week 70
時間枠：Week 70
|
Week 70
|
|
|
Arm B: Change From Baseline in MVI score at Week 70
時間枠：Week 70
|
Week 70
|
|
|
Arms A, B, and C: Percentage of Participants With T-Cell Mediated Rejection (TCMR) by Biopsy at Weeks 24 and 48
時間枠：Weeks 24 and 48
|
Weeks 24 and 48
|
|
|
Arm B: Percentage of Participants With TCMR by Biopsy at Week 70
時間枠：Week 70
|
Week 70
|
|
|
Arms A and B: Serum Concentration of Mezagitamab
時間枠：Pre-dose and at multiple time points post-dose up to Week 70
|
Pre-dose and at multiple time points post-dose up to Week 70
|
|
|
Arms A, B and C: Number of Participants With Anti-Drug Antibody
時間枠：Pre-dose and at multiple time points post-dose up to Week 70
|
Pre-dose and at multiple time points post-dose up to Week 70
|
|
|
Arms A, B and C: Number of Participants With Neutralizing Antibody
時間枠：Pre-dose and at multiple time points post-dose up to Week 70
|
Pre-dose and at multiple time points post-dose up to Week 70
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Study Director、Takeda
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2029年1月15日
研究の完了 (推定)
2029年1月15日
試験登録日
最初に提出
2026年5月22日
QC基準を満たした最初の提出物
2026年5月22日
最初の投稿 (実際)
2026年5月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年6月2日
最終確認日
2026年6月1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?
はい
IPD プランの説明
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5).
These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD 共有アクセス基準
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/.
For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
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