Clinical trial NCT05106387: An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease (CKD)
Keywords: Kidney Transplant
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is designed to collect safety and outcomes data in patients aged 18 through 70 years who receive a kidney transplant and were administered vosentamig in study R5459-RT-1944 \[NCT05092347\].

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Received at least 1 dose of treatment with vonsetamig in study R5459-RT-1944 \[NCT05092347\].
2. Received after acceptable crossmatching, a kidney transplant while enrolled in study R5459-RT-1944
3. Willing and able to comply with clinic visits and study-related procedures
4. 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

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: Up to 12 months post-kidney transplant
measure: Incidence of Serious Adverse Events
timeFrame: Up to 12 months post-kidney transplant
Secondary outcomes:
measure: Incidence of biopsy-proven kidney allograft rejection
timeFrame: Up to 12 Months
measure: Time to diagnosis of biopsy-proven kidney allograft rejection
timeFrame: Up to 12 Months
measure: Responsiveness to therapy by 12 months of biopsy-proven kidney allograft rejection
timeFrame: Up to 12 Months
measure: Incidence of graft loss
timeFrame: Up to 12 Months
measure: Time to graft loss
timeFrame: Up to 12 Months
measure: Change in estimated glomerular filtration rate (eGFR) over time
timeFrame: Up to 12 Months
measure: Incidence of delayed graft function
timeFrame: Up to Day 7
measure: Percent Change in anti-HLA alloantibodies
timeFrame: Up to 12 months
measure: Mean Fluorescence Intensity Change in anti-HLA alloantibodies
timeFrame: Up to 12 months
measure: Change in Calculated panel-reactive antibody (cPRA) over time
timeFrame: Up to 12 Months
measure: Percent Change in donor-specific anti-HLA alloantibodies
timeFrame: Up to 12 Months
measure: Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies
timeFrame: Up to 12 Months
measure: Incidence of de novo anti-HLA alloantibody development
timeFrame: Up to 12 Months
measure: Serum Concentrations of Ig classes (IgG, IgA, and IgM) over time
timeFrame: Up to 12 Months
measure: Percent change from baseline of circulating serum concentrations of Ig classes
timeFrame: Up to 12 Months
measure: Serum Concentration of vonsetamig
timeFrame: Up to 12 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: San Francisco
country: United States
facility: Connie Frank Transplant Center at UCSF
state: California
city: New Haven
country: United States
facility: Yale University of Medicine
state: Connecticut
city: Chicago
country: United States
facility: Comprehensive Transplant Center
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins Hospital
state: Maryland
city: New York
country: United States
facility: New York University Langone Health
state: New York
city: Philadelphia
country: United States
facility: Penn Transplant Institute
state: Pennsylvania
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: