Transplant RejectionPhase 2NCT05156710
BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
A Phase 2 study testing BIVV020 (SAR445088), Intravenous immunoglobulin (IVIg) and Rituximab or biosimilar in people with Transplant Rejection, run by Sanofi at 27 sites in 7 countries.
Trial summary
Primary Objectives: Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR Secondary Objectives: To assess the overall efficacy of BIVV020 in prevention or treatment of AMR To characterize the safety and tolerability of BIVV020 in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Rejection
- What is being tested?
- BIVV020 (SAR445088), Intravenous immunoglobulin (IVIg) and Rituximab or biosimilar
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 27 sitesin 7 countries
- Study dates
- 9 Jun 2022to 20 Oct 2026
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
- BMI ≤ 40 kg/m2.
- Contraceptive use by women during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).
- Contraceptive use by men during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).
Who cannot join
- Participants who are ABO incompatible with their donors.
- Participants with known active ongoing infection as per below:
- Positive HIV.
- Positive HBV.
- HCV with detectable HCV RNA.
- Within 4 weeks of first study intervention: any serious infection, or any active bacterial infection, or any other infection which is clinically significant in the option of the Investigator, unless it can be confirmed that infection was cleared at least 3 days prior to first study intervention.
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- History of active tuberculosis (TB) regardless of treatment.
- Participants with clinical diagnosis of systemic lupus erythematosus (SLE).
- Prior treatment with complement system inhibitor within 5 times the half-life.
- Current enrollment in any other clinical study where the last investigational study treatment administration was within 5 half-lives from study intervention initiation.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
27 sites in 7 countries.
27 sites in 7 countries
United States7 sites
Massachusetts General Hospital- Site Number : 8400007
Boston, Massachusetts, 02114
Brigham & Women's Hospital- Site Number : 8400004
Boston, Massachusetts, 02115
Cedars-Sinai Medical Center- Site Number : 8400100
Los Angeles, California, 90048
University of California Los Angeles Medical Center- Site Number : 8400103
Los Angeles, California, 90095
University of Wisconsin Hospitals and Clinics- Site Number : 8400003
Madison, Wisconsin, 53792
NYU Langone Medical Center- Site Number : 8400102
New York, New York, 10016
University of California San Francisco - Parnassus Heights- Site Number : 8400001
San Francisco, California, 94143
Canada4 sites
Investigational Site Number : 1240002
London, Ontario, N6A 5A5
Investigational Site Number : 1240003
Montreal, Quebec, H4A 3J1
Investigational Site Number : 1240101
Vancouver, British Columbia, V5Z 1M9
Investigational Site Number : 1240001
Vancouver, British Columbia, V6Z 1Y6
France4 sites
Investigational Site Number : 2500007
Bordeaux, 33076
Investigational Site Number : 2500002
Créteil, 94010
Investigational Site Number : 2500001
Paris, 75010
Investigational Site Number : 2500005
Toulouse, 31059
Italy4 sites
Investigational Site Number : 3800004
Bologna, Emilia-Romagna, 40138
Investigational Site Number : 3800001
Brescia, Lombardy, 25123
Investigational Site Number : 3800003
Milan, Milano, 20162
Investigational Site Number : 3800002
Rome, Lazio, 00168
Germany3 sites
Investigational Site Number : 2760002
Berlin, 13353
Investigational Site Number : 2760004
Essen, 45147
Investigational Site Number : 2760001
Munich, 81675
Spain3 sites
Investigational Site Number : 7240004
Barcelona, Barcelona [Barcelona], 08035
Investigational Site Number : 7240003
Madrid, Madrid, Comunidad de, 28041
Investigational Site Number : 7240002
Madrid, Madrid, Comunidad de, 28046
Sweden2 sites
Investigational Site Number : 7520001
Huddinge, 141 57
Investigational Site Number : 7520002
Uppsala, 751 85
About this study
Official title: A Multi-cohort, Randomized, Phase 2, Open-label Study to Assess the Preliminary Efficacy, Safety, and Pharmacokinetics of BIVV020 for Prevention and Treatment of Antibody-mediated Rejection in Adult Kidney Transplant Recipients.
Primary Objectives:
- Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR
- Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR
Secondary Objectives:
- To assess the overall efficacy of BIVV020 in prevention or treatment of AMR
- To characterize the safety and tolerability of BIVV020 in kidney transplant participants
- To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants
- To evaluate the immunogenicity of BIVV020
Read the detailed description
Up to approximately 2 years
- Conditions
- Transplant Rejection
- Being tested
- BIVV020 (SAR445088), Intravenous immunoglobulin (IVIg), Rituximab or biosimilar, Antithymocyte globulin (ATG), Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIVV020 (SAR445088)Drug
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Intravenous immunoglobulin (IVIg)Drug
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Rituximab or biosimilarDrug
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Antithymocyte globulin (ATG)Drug
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
TacrolimusDrug
Pharmaceutical Form: Tablet Route of Administration: Oral
MycophenolateDrug
Pharmaceutical Form: Tablet Route of Administration: Oral
CorticosteroidsDrug
Pharmaceutical Form: Vary Route of Administration: Vary
| Study group | Role | What they receive |
|---|---|---|
| BIVV020 with Standard of Care (SOC) Cohort A | Experimental | Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate. Receives: Drug: BIVV020 (SAR445088); Drug: Antithymocyte globulin (ATG); Drug: Tacrolimus; Drug: Mycophenolate |
| BIVV020 with Standard of Care (SOC) Cohort B | Experimental | Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab. Receives: Drug: BIVV020 (SAR445088); Drug: Intravenous immunoglobulin (IVIg); Drug: Rituximab or biosimilar; Drug: Corticosteroids |
| Standard of Care (SOC) Cohort B | Other | SOC includes plasmapheresis, IVIg, corticosteroids, rituximab. Receives: Drug: Intravenous immunoglobulin (IVIg); Drug: Rituximab or biosimilar; Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to Week 49
Secondary outcomes (11)
Cohort A: Treatment failure rate per local assessment using Banff criteria 2019
Measured: Up to Week 49
Cohort B: AMR resolution rate per local assessment using Banff criteria 2019
Measured: 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)
Measured: Up to 22 weeks after end of treatment period
Change in renal function from baseline per central laboratory assessment using protein: creatinine ratio
Measured: Up to 22 weeks after end of treatment period
Change in allograft histopathology Banff score
Measured: Up to Week 49
Graft survival as predicted by iBOX
Measured: Up to Week 49
Assessment of adverse events (AEs)
Number of participants with treatment emergent adverse events (TEAEs)/ serious adverse events (SAES), laboratory abnormalities
Measured: Up to end of study, up to approximately 2 years
Change in systemic lupus erythematosus (SLE) panel
Measured: 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
Measured: 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
Measured: Up to 22 weeks after end of treatment period
Number of participants with anti-BIVV020 antibodies
Number of participants developed drug-induced ADAs
Measured: Up to 22 weeks after end of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start9 Jun 2022
- Primary completion21 Oct 2025
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transplant RejectionStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156710
- Sponsor's protocol ID
- ACT17012
- Other IDs
- U1111-1267-2612, 2023-509936-25, 2021-000010-41, 2023
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2021
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Karpman D, Bekassy Z, Grunenwald A, Roumenina LT. A role for complement blockade in kidney transplantation. Cell Mol Immunol. 2022 Jul;19(7):755-757. doi: 10.1038/s41423-022-00854-5. Epub 2022 Mar 24. No abstract available.
PubMed 35332298
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-cohort, Randomized, Phase 2, Open-label Study to Assess the Preliminary Efficacy, Safety, and Pharmacokinetics of BIVV020 for Prevention and Treatment of Antibody-mediated Rejection in Adult Kidney Transplant Recipients.
- ClinicalTrials.gov ID
- NCT05156710
- Acronym / sponsor ID
- ACT17012
- Conditions
- Transplant Rejection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 14 Dec 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.
Primary Objectives:
- Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR
- Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR
Secondary Objectives:
- To assess the overall efficacy of BIVV020 in prevention or treatment of AMR
- To characterize the safety and tolerability of BIVV020 in kidney transplant participants
- To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants
- To evaluate the immunogenicity of BIVV020
Detailed description
Up to approximately 2 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIVV020 with Standard of Care (SOC) Cohort A | Experimental | Drug: BIVV020 (SAR445088), Drug: Antithymocyte globulin (ATG), Drug: Tacrolimus, Drug: MycophenolateEligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate. |
| BIVV020 with Standard of Care (SOC) Cohort B | Experimental | Drug: BIVV020 (SAR445088), Drug: Intravenous immunoglobulin (IVIg), Drug: Rituximab or biosimilar, Drug: CorticosteroidsEligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab. |
| Standard of Care (SOC) Cohort B | Other | Drug: Intravenous immunoglobulin (IVIg), Drug: Rituximab or biosimilar, Drug: CorticosteroidsSOC includes plasmapheresis, IVIg, corticosteroids, rituximab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- -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.
- BMI ≤ 40 kg/m2.
- Contraceptive use by women during the treatment period, and for at least 49 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant).
Key exclusion criteria (11 listed)
- Participants who are ABO incompatible with their donors.
- Participants with known active ongoing infection as per below:
- History of active tuberculosis (TB) regardless of treatment.
- Participants with clinical diagnosis of systemic lupus erythematosus (SLE).
- Prior treatment with complement system inhibitor within 5 times the half-life.
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 |
|---|---|---|
| BIVV020 (SAR445088)Pharmaceutical Form: Solution for injection Route of Administration: Intravenous | Drug | BIVV020 with Standard of Care (SOC) Cohort A, BIVV020 with Standard of Care (SOC) Cohort B |
| Intravenous immunoglobulin (IVIg)Pharmaceutical Form: Solution for injection Route of Administration: Intravenous | Drug | BIVV020 with Standard of Care (SOC) Cohort B, Standard of Care (SOC) Cohort B |
| Rituximab or biosimilarPharmaceutical Form: Solution for injection Route of Administration: Intravenous | Drug | BIVV020 with Standard of Care (SOC) Cohort B, Standard of Care (SOC) Cohort B |
| Antithymocyte globulin (ATG)Pharmaceutical Form: Solution for injection Route of Administration: Intravenous | Drug | BIVV020 with Standard of Care (SOC) Cohort A |
| TacrolimusPharmaceutical Form: Tablet Route of Administration: Oral | Drug | BIVV020 with Standard of Care (SOC) Cohort A |
| MycophenolatePharmaceutical Form: Tablet Route of Administration: Oral | Drug | BIVV020 with Standard of Care (SOC) Cohort A |
| CorticosteroidsPharmaceutical Form: Vary Route of Administration: Vary | Drug | BIVV020 with Standard of Care (SOC) Cohort B, Standard of Care (SOC) Cohort B |
Primary outcome
Cohort A: Treatment failure rate
Time frame: Up to Week 49
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.
Cohort B: AMR resolution rate
Time frame: Up to Week 49
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.
11 secondary outcomes
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)
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
Time frame: Up to 22 weeks after end of treatment period
Plasma exposure of BIVV020 assessing pharmacokinetic parameter AUC
Time frame: Up to 22 weeks after end of treatment period
Number of participants with anti-BIVV020 antibodies
Time frame: Up to 22 weeks after end of treatment period
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 21 Aug 2026.
- Derived from this study: PubMed 35332298Karpman D, Bekassy Z, Grunenwald A, Roumenina LT. A role for complement blockade in kidney transplantation. Cell Mol Immunol. 2022 Jul;19(7):755-757. doi: 10.1038/s41423-022-00854-5. Epub 2022 Mar 24. No abstract available.
- ACT17012 kidney transplant - antibody-mediated rejection websiteLink provided by the sponsor.
- ACT17012 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIVV020 (SAR445088), Intravenous immunoglobulin (IVIg) and Rituximab or biosimilar in people with Transplant Rejection, run by Sanofi at 27 sites in 7 countries.
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 6 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Canada, France, Italy, Germany and 2 more countries. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort A: Treatment failure rate (time frame: Up to Week 49). 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?
On the ClinicalTrials.gov record for NCT05156710, which also lists 1 linked publication.
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 21 Aug 2026.