Chronic Kidney Disease (CKD)NCT05106387
An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant
An observational study of Chronic Kidney Disease (CKD), run by Regeneron Pharmaceuticals at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- What is being tested?
- Noninterventional
- How many people
- 20 participants
- Where
- 9 sitesUnited States
- Study dates
- 19 Oct 2023to 23 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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].
Who may be able to join
- 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
Who cannot join
- 1.There are no exclusion criteria for this study.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 8 recruiting
- Recruiting
John Hopkins Hospital
Baltimore, Maryland, 21224
- Recruiting
Comprehensive Transplant Center
Chicago, Illinois, 60611
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Completed
Yale University of Medicine
New Haven, Connecticut, 06520
- Recruiting
New York University Langone Health
New York, New York, 10016
- Recruiting
University of California Irvine
Orange, California, 92868
- Recruiting
Penn Transplant Institute
Philadelphia, Pennsylvania, 19104
- Recruiting
Connie Frank Transplant Center at UCSF
San Francisco, California, 94143
About this study
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
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.
- Conditions
- Chronic Kidney Disease (CKD)
- Being tested
- Noninterventional
- Keywords
- Kidney Transplant
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoninterventionalDrug
Also called REGN5459
No investigational treatment will be given in this noninterventional extension study
| Study group | Role | What they receive |
|---|---|---|
| Vonsetamig in study R5459-RT-1944 | Received a kidney transplant and were administered vonsetamig in study R5459-RT-1944 [NCT05092347]. Receives: Drug: Noninterventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Measured: Up to 12 months post-kidney transplant
Incidence of Serious Adverse Events
Measured: Up to 12 months post-kidney transplant
Secondary outcomes (16)
Incidence of biopsy-proven kidney allograft rejection
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)
Measured: Up to 12 Months
Time to diagnosis of biopsy-proven kidney allograft rejection
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)
Measured: Up to 12 Months
Responsiveness to therapy by 12 months of biopsy-proven kidney allograft rejection
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)
Measured: Up to 12 Months
Incidence of graft loss
Incidence of graft loss (defined as becoming dialysis-dependent) by 12 months
Measured: Up to 12 Months
Time to graft loss
Time to graft loss (defined as becoming dialysis-dependent) by 12 months
Measured: Up to 12 Months
Change in estimated glomerular filtration rate (eGFR) over time
Measured: Up to 12 Months
Incidence of delayed graft function
Incidence of delayed graft function (defined as the use of dialysis within 7 days posttransplant)
Measured: Up to Day 7
Percent Change in anti-HLA alloantibodies
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
Measured: Up to 12 months
Mean Fluorescence Intensity Change in anti-HLA alloantibodies
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
Measured: Up to 12 months
Change in Calculated panel-reactive antibody (cPRA) over time
Measured: Up to 12 Months
Percent Change in donor-specific anti-HLA alloantibodies
Percent Change in donor-specific anti-HLA alloantibodies compared with recipient pre-transplant anti-HLA alloantibody levels
Measured: Up to 12 Months
Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies
Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies compared with recipient pre-transplant anti-HLA alloantibody levels
Measured: Up to 12 Months
Incidence of de novo anti-HLA alloantibody development
Cumulative incidence of de novo anti-HLA alloantibody development by SAB assay by 12 months
Measured: Up to 12 Months
Serum Concentrations of Ig classes (IgG, IgA, and IgM) over time
Measured: Up to 12 Months
Percent change from baseline of circulating serum concentrations of Ig classes
Percent change from baseline of circulating serum concentrations of Ig classes (IgG, IgA, and IgM)
Measured: Up to 12 Months
Serum Concentration of vonsetamig
Measured: Up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start19 Oct 2023
- Primary completion14 Jun 2027 (estimated)
- Study completion23 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106387
- Sponsor's protocol ID
- R5459-RT-1956
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05106387
- Acronym / sponsor ID
- R5459-RT-1956
- Conditions
- Chronic Kidney Disease (CKD)
- Keywords
- Kidney Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 14 Jun 2027 (estimated)
- Study completion
- 23 Feb 2028 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vonsetamig in study R5459-RT-1944 | – | Drug: NoninterventionalReceived a kidney transplant and were administered vonsetamig in study R5459-RT-1944 [NCT05092347]. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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].
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 1.There are no exclusion criteria for this study.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NoninterventionalAlso: REGN5459No investigational treatment will be given in this noninterventional extension study | Drug | Vonsetamig in study R5459-RT-1944 |
Primary outcome
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
16 secondary outcomes
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
Incidence of de novo anti-HLA alloantibody development
Time frame: Up to 12 Months
Serum Concentrations of Ig classes (IgG, IgA, and IgM) over time
Time frame: Up to 12 Months
Percent change from baseline of circulating serum concentrations of Ig classes
Time frame: Up to 12 Months
Serum Concentration of vonsetamig
Time frame: Up to 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease (CKD), run by Regeneron Pharmaceuticals at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: Up to 12 months post-kidney transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.