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

Chronic Kidney Disease (CKD) Clinical Trial

Official title:

A Noninterventional Extension Study for Patients Treated in Study R5459-RT-1944 With REGN5459 or REGN5458 (BCMA x CD3 Bispecific Antibodies) Who Receive A Kidney Transplant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05106387
• Other study ID #: R5459-RT-1956
• Status: Recruiting
• Start date: October 19, 2023
• Est. completion date: May 21, 2026

Study information

• Verified date: November 2023
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of the study is to assess adverse events (AEs) and serious adverse events (SAEs) in kidney transplant recipients previously treated with REGN5459 or REGN5458 in the R5459-RT-1944 study.

The secondary objectives of the study are to evaluate each of the following in kidney transplant recipients previously treated with REGN5459 or REGN5458:

• Rates and classification of antibody-mediated and T-cell-mediated kidney allograft rejection

• Graft survival

• Allograft function

• Delayed allograft function

• Anti-human leukocyte antigen (HLA) alloantibody levels and calculated panel-reactive antibody (cPRA)

• Emergence of de novo donor-specific antibodies

• Circulating immunoglobulin (Ig) classes (isotypes)

• Pharmacokinetics (PK) of REGN5459 or REGN5458

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 21, 2026
• Est. primary completion date: May 21, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Received at least 1 dose of treatment with REGN5459 or REGN5458 in study R5459-RT-1944

• Received, or scheduled to receive 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:

• There are no exclusion criteria for this study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Noninterventional
No investigational treatment will be given in this noninterventional extension study

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Northwestern University Comprehensive Transplant Center	Chicago	Illinois
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Yale University School of Medicine Transplant Surgery	New Haven	Connecticut
United States	New York University Langone Health - Transplant Institute	New York	New York
United States	University of California Irvine	Orange	California
United States	University of Pennsylvania-Penn Transplant Institute	Philadelphia	Pennsylvania
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events		Up to 12 months post-kidney transplant
Primary	Incidence of Serious Adverse Events		Up to 12 months post-kidney transplant
Secondary	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)	Up to 12 Months
Secondary	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)	Up to 12 Months
Secondary	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)	Up to 12 Months
Secondary	Incidence of graft loss	Incidence of graft loss (defined as becoming dialysis-dependent) by 12 months	Up to 12 Months
Secondary	Time to graft loss	Time to graft loss (defined as becoming dialysis-dependent) by 12 months	Up to 12 Months
Secondary	Change in estimated glomerular filtration rate (eGFR) over time		Up to 12 Months
Secondary	Incidence of delayed graft function	Incidence of delayed graft function (defined as the use of dialysis within 7 days posttransplant)	Up to Day 7
Secondary	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	Up to 12 months
Secondary	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	Up to 12 months
Secondary	Change in Calculated panel-reactive antibody (cPRA) over time		Up to 12 Months
Secondary	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	Up to 12 Months
Secondary	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	Up to 12 Months
Secondary	Incidence of de novo anti-HLA alloantibody development	Cumulative incidence of de novo anti-HLA alloantibody development by SAB assay by 12 months	Up to 12 Months
Secondary	Serum Concentrations of Ig classes (IgG, IgA, and IgM) over time		Up to 12 Months
Secondary	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)	Up to 12 Months
Secondary	Serum Concentration of R5458		Up to 12 Months
Secondary	Serum Concentration of R5459		Up to 12 Months