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NCT Number: NCT05106387

An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant

The main purpose of this study is to continue to see how vonsetamig works in the body and to monitor the outcomes after kidney transplant for participants previously treated in the R5459-RT-1944 study (NCT05092347).

No study drug will be given during this study.

Recruiting

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Key information

Conditions

Chronic Kidney Disease (CKD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Received at least 1 dose of treatment with vonsetamig in study R5459-RT-1944 [NCT05092347].
  • Received after acceptable crossmatching, a kidney transplant while enrolled in study R5459-RT-1944
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide informed consent signed by study patient or legally acceptable representative

Exclusion criteria

1.There are no exclusion criteria for this study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

Noninterventional

Drug

No investigational treatment will be given in this noninterventional extension study

Other names: REGN5459

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: Up to 12 months post-kidney transplant

  2. Incidence of Serious Adverse Events

    Time frame: Up to 12 months post-kidney transplant

Secondary outcomes

  1. Incidence of biopsy-proven kidney allograft rejection

    Time frame: Up to 12 Months

    Responsiveness to therapy by 12 months of each of the following types of biopsy-proven kidney allograft rejection according to Banff classification:

    • Active antibody-mediated rejection (AMR) (Category 2)
    • Chronic active AMR (Category 2)
    • Acute t-cell-mediated rejection (TCMR) (Category 4)
    • Chronic active TCMR (Category 4)

  2. Time to diagnosis of biopsy-proven kidney allograft rejection

    Time frame: Up to 12 Months

    Responsiveness to therapy by 12 months of each of the following types of biopsy-proven kidney allograft rejection according to Banff classification:

    • Active antibody-mediated rejection (AMR) (Category 2)
    • Chronic active AMR (Category 2)
    • Acute t-cell-mediated rejection (TCMR) (Category 4)
    • Chronic active TCMR (Category 4)

  3. Responsiveness to therapy by 12 months of biopsy-proven kidney allograft rejection

    Time frame: Up to 12 Months

    Responsiveness to therapy by 12 months of each of the following types of biopsy-proven kidney allograft rejection according to Banff classification:

    • Active antibody-mediated rejection (AMR) (Category 2)
    • Chronic active AMR (Category 2)
    • Acute t-cell-mediated rejection (TCMR) (Category 4)
    • Chronic active TCMR (Category 4)

  4. Incidence of graft loss

    Time frame: Up to 12 Months

    Incidence of graft loss (defined as becoming dialysis-dependent) by 12 months

  5. Time to graft loss

    Time frame: Up to 12 Months

    Time to graft loss (defined as becoming dialysis-dependent) by 12 months

  6. Change in estimated glomerular filtration rate (eGFR) over time

    Time frame: Up to 12 Months

  7. Incidence of delayed graft function

    Time frame: Up to Day 7

    Incidence of delayed graft function (defined as the use of dialysis within 7 days posttransplant)

  8. Percent Change in anti-HLA alloantibodies

    Time frame: Up to 12 months

    Percent Change in anti-HLA alloantibodies (SAB assay) compared with pretransplant levels at 2, 3, 6, and 12 months, and at the time of suspected clinical episodes of allograft rejection

  9. Mean Fluorescence Intensity Change in anti-HLA alloantibodies

    Time frame: Up to 12 months

    Mean Fluorescence Intensity (MFI) Change in anti-HLA alloantibodies (SAB assay) compared with pretransplant levels at 2, 3, 6, and 12 months, and at the time of suspected clinical episodes of allograft rejection

  10. Change in Calculated panel-reactive antibody (cPRA) over time

    Time frame: Up to 12 Months

  11. Percent Change in donor-specific anti-HLA alloantibodies

    Time frame: Up to 12 Months

    Percent Change in donor-specific anti-HLA alloantibodies compared with recipient pre-transplant anti-HLA alloantibody levels

  12. Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies

    Time frame: Up to 12 Months

    Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies compared with recipient pre-transplant anti-HLA alloantibody levels

  13. Incidence of de novo anti-HLA alloantibody development

    Time frame: Up to 12 Months

    Cumulative incidence of de novo anti-HLA alloantibody development by SAB assay by 12 months

  14. Serum Concentrations of Ig classes (IgG, IgA, and IgM) over time

    Time frame: Up to 12 Months

  15. Percent change from baseline of circulating serum concentrations of Ig classes

    Time frame: Up to 12 Months

    Percent change from baseline of circulating serum concentrations of Ig classes (IgG, IgA, and IgM)

  16. Serum Concentration of vonsetamig

    Time frame: Up to 12 Months

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Noninterventional Extension Study for Patients Treated in Study R5459-RT-1944 With Vonsetamig (BCMA x CD3 Bispecific Antibody) Who Receive a Kidney Transplant

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Nov 3, 2021
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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