A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
2026년 6월 2일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
36
단계
- 2 단계
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연구 연락처
- 이름: Takeda Contact
- 전화번호: +1-877-825-3327
- 이메일: medinfoUS@takeda.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
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설명
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.
공부 계획
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연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
Mezagitamab-matching placebo SC injection.
|
|
실험적: Arm B: Mezagitamab
Participants will receive mezagitamab up to Week 48, followed by an observation period up to Week 70.
|
Mezagitamab subcutaneous (SC) injection.
다른 이름들:
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Arms A, B, and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
기간: 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
|
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Arms A, B, and C: Number of Participants With Related TEAEs
기간: 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)
기간: 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
|
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Arms A, B, and C: Number of Participants With AEs of Special Interest
기간: Up to Week 70
|
AEs of special interest are AEs that are considered specific to the IMP.
|
Up to Week 70
|
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Arms A, B, and C: Number of Participants With AE Leading to Treatment Discontinuation
기간: Up to Week 70
|
Up to Week 70
|
|
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Arms A, B, and C: Number of Participants With Clinically Significant Abnormal Laboratory Test Results and Vital Signs
기간: Up to Week 70
|
Up to Week 70
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Arms A, B, and C: Percentage of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Weeks 24 and 48
기간: 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.
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Weeks 24 and 48
|
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Arms A, B, and C: Microvascular Inflammation (MVI) Score in Biopsy Samples at Weeks 24 and 48
기간: 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.
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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
기간: Weeks 24 and 48
|
Weeks 24 and 48
|
|
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Arms A, B, and C: Change From Baseline in MVI score at Weeks 24 and 48
기간: Baseline, Weeks 24 and 48
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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
기간: 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.
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Baseline, Weeks 24, 48 and 70
|
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Arms A, B, and C: Change From Baseline in Donor-Derived Cell-Free DNA (dd-cfDNA) at Weeks 24, 48 and 70
기간: 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.
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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
기간: 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
기간: Week 70
|
Week 70
|
|
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Arm B: MVI Score in Biopsy Samples at Week 70
기간: Week 70
|
Week 70
|
|
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Arm B: Percentage of Participants Who Achieve a MVI Score of 0 at Week 70
기간: Week 70
|
Week 70
|
|
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Arm B: Change From Baseline in MVI score at Week 70
기간: Week 70
|
Week 70
|
|
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Arms A, B, and C: Percentage of Participants With T-Cell Mediated Rejection (TCMR) by Biopsy at Weeks 24 and 48
기간: Weeks 24 and 48
|
Weeks 24 and 48
|
|
|
Arm B: Percentage of Participants With TCMR by Biopsy at Week 70
기간: Week 70
|
Week 70
|
|
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Arms A and B: Serum Concentration of Mezagitamab
기간: 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
기간: 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
기간: 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
|
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연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2029년 1월 15일
연구 완료 (추정된)
2029년 1월 15일
연구 등록 날짜
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2026년 5월 22일
QC 기준을 충족하는 최초 제출
2026년 5월 22일
처음 게시됨 (실제)
2026년 5월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 4일
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2026년 6월 2일
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2026년 6월 1일
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