A Phase 2 interventional study of BIVV020 (SAR445088) and Intravenous immunoglobulin (IVIg) in Transplant Rejection, sponsored by Sanofi. Active, not recruiting at 27 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
Primary Objectives:
Secondary Objectives:
Up to approximately 2 years
Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
-Participant intended to receive SOC therapy per Investigator's judgment and local practice.
Cohort A: Participants with chronic kidney disease who will receive a kidney transplant from a living or deceased donor.
Cohort B: Participants who are kidney transplant recipients diagnosed with active AMR.
Exclusion Criteria:
Participants with known active ongoing infection as per below:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate.
Drug: BIVV020 (SAR445088) · Drug: Antithymocyte globulin (ATG) · Drug: Tacrolimus · Drug: Mycophenolate
Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab.
Drug: BIVV020 (SAR445088) · Drug: Intravenous immunoglobulin (IVIg) · Drug: Rituximab or biosimilar · Drug: Corticosteroids
SOC includes plasmapheresis, IVIg, corticosteroids, rituximab.
Drug: Intravenous immunoglobulin (IVIg) · Drug: Rituximab or biosimilar · Drug: Corticosteroids
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Pharmaceutical Form: Tablet Route of Administration: Oral
Pharmaceutical Form: Tablet Route of Administration: Oral
Pharmaceutical Form: Vary Route of Administration: Vary
Cohort A: Treatment failure rate
Defined as the proportion of participants meeting at least one of the following criteria: * Biopsy-proven active AMR as per Banff Criteria 2019 as per central pathology assessment, * Graft loss.
Time frame: Up to Week 49
Cohort B: AMR resolution rate
Defined as the proportion of participants with post-treatment biopsy not fulfilling active AMR diagnosis criteria as per Banff Criteria 2019 as per central pathology assessment.
Time frame: Up to Week 49
Cohort A: Treatment failure rate per local assessment using Banff criteria 2019
Time frame: Up to Week 49
Cohort B: AMR resolution rate per local assessment using Banff criteria 2019
Time frame: Up to Week 49
Change in renal function from baseline per central laboratory assessment of estimated glomerular filtration rate (eGFR) from serum creatinine using Modification of Diet in Renal Disease equation (MDRD)
Time frame: Up to 22 weeks after end of treatment period
Change in renal function from baseline per central laboratory assessment using protein: creatinine ratio
Time frame: Up to 22 weeks after end of treatment period
Change in allograft histopathology Banff score
Time frame: Up to Week 49
Graft survival as predicted by iBOX
Time frame: Up to Week 49
Assessment of adverse events (AEs)
Number of participants with treatment emergent adverse events (TEAEs)/ serious adverse events (SAES), laboratory abnormalities
Time frame: Up to end of study, up to approximately 2 years
Change in systemic lupus erythematosus (SLE) panel
Time frame: Up to 22 weeks after end of treatment period
Plasma exposure of BIVV020 assessing pharmacokinetic parameter Cmin
Cmin is defined as the minimum concentration after injection
Time frame: Up to 22 weeks after end of treatment period
Plasma exposure of BIVV020 assessing pharmacokinetic parameter AUC
AUC is defined as the area under plasma concentration versus time curve
Time frame: Up to 22 weeks after end of treatment period
Number of participants with anti-BIVV020 antibodies
Number of participants developed drug-induced ADAs
Time frame: Up to 22 weeks after end of treatment period
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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