An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Noninterventional.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease (CKD). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug Noninterventional
No investigational treatment will be given in this noninterventional extension study
Primary outcome measures
- Incidence of Adverse Events [Time frame: Up to 12 months post-kidney transplant]
- Incidence of Serious Adverse Events [Time frame: Up to 12 months post-kidney transplant]
Secondary outcome measures (12)
- Incidence of biopsy-proven kidney allograft rejection [Time frame: Up to 12 Months]
- Time to diagnosis of biopsy-proven kidney allograft rejection [Time frame: Up to 12 Months]
- Responsiveness to therapy by 12 months of biopsy-proven kidney allograft rejection [Time frame: Up to 12 Months]
- Incidence of graft loss [Time frame: Up to 12 Months]
- Time to graft loss [Time frame: Up to 12 Months]
- Change in estimated glomerular filtration rate (eGFR) over time [Time frame: Up to 12 Months]
- Incidence of delayed graft function [Time frame: Up to Day 7]
- Percent Change in anti-HLA alloantibodies [Time frame: Up to 12 months]
- Mean Fluorescence Intensity Change in anti-HLA alloantibodies [Time frame: Up to 12 months]
- Change in Calculated panel-reactive antibody (cPRA) over time [Time frame: Up to 12 Months]
- Percent Change in donor-specific anti-HLA alloantibodies [Time frame: Up to 12 Months]
- Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies [Time frame: Up to 12 Months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- Cedars-Sinai Medical Center — Los Angeles
- University of California Irvine — Orange
- Connie Frank Transplant Center at UCSF — San Francisco
- Yale University of Medicine — New Haven
- Comprehensive Transplant Center — Chicago
- John Hopkins Hospital — Baltimore
- University of Minnesota — Minneapolis
- New York University Langone Health — New York
- … and 1 more center
Identifiers
NCT: NCT05106387 · R5459-RT-1956