A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
2. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
36
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Takeda Contact
- Telefonnummer: +1-877-825-3327
- E-post: medinfoUS@takeda.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
Mezagitamab-matching placebo SC injection.
|
|
Eksperimentell: Arm B: Mezagitamab
Participants will receive mezagitamab up to Week 48, followed by an observation period up to Week 70.
|
Mezagitamab subcutaneous (SC) injection.
Andre navn:
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Arms A, B, and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to Week 70
|
Up to Week 70
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Arms A, B, and C: Percentage of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Weeks 24 and 48
Tidsramme: 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
Tidsramme: 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
|
|
Arms A, B, and C: Percentage of Participants Who Achieve a MVI Score of 0 at Weeks 24 and 48
Tidsramme: Weeks 24 and 48
|
Weeks 24 and 48
|
|
|
Arms A, B, and C: Change From Baseline in MVI score at Weeks 24 and 48
Tidsramme: Baseline, Weeks 24 and 48
|
Baseline, Weeks 24 and 48
|
|
|
Arms A, B, and C: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Weeks 24, 48 and 70
Tidsramme: 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
Tidsramme: 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
|
|
Arms A, B, and C: Change From Baseline in Urine Protein Creatinine Ratio (UPCR) at Weeks 24, 48 and 70
Tidsramme: 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
|
|
Arm B: Percentage of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 70
Tidsramme: Week 70
|
Week 70
|
|
|
Arm B: MVI Score in Biopsy Samples at Week 70
Tidsramme: Week 70
|
Week 70
|
|
|
Arm B: Percentage of Participants Who Achieve a MVI Score of 0 at Week 70
Tidsramme: Week 70
|
Week 70
|
|
|
Arm B: Change From Baseline in MVI score at Week 70
Tidsramme: 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
Tidsramme: Weeks 24 and 48
|
Weeks 24 and 48
|
|
|
Arm B: Percentage of Participants With TCMR by Biopsy at Week 70
Tidsramme: Week 70
|
Week 70
|
|
|
Arms A and B: Serum Concentration of Mezagitamab
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Study Director, Takeda
Publikasjoner og nyttige lenker
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Hjelpsomme linker
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- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
15. januar 2029
Studiet fullført (Antatt)
15. januar 2029
Datoer for studieregistrering
Først innsendt
22. mai 2026
Først innsendt som oppfylte QC-kriteriene
22. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- TAK-079-2002
- 2026-526239-20-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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