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Monoclonal Antibodies

BIVV020 for Transplant Rejection

Phase 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohort B: Participants who are kidney transplant recipients diagnosed with active AMR
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to end of study, up to approximately 2 years
Awards & highlights

Study Summary

This trial will evaluate the efficacy of BIVV020 in the prevention and treatment of AMR in kidney transplant participants. Secondary objectives include assessing overall efficacy, safety and tolerability, PK profile, and immunogenicity of BIVV020.

Who is the study for?
This trial is for kidney transplant recipients aged 18-75 with active antibody-mediated rejection (Cohort B), or those about to receive a transplant and are at high risk of rejection (Cohort A). Participants must have a BMI ≤ 40 kg/m2, agree to use contraception, and not be infected with HIV/HCV/HBV or have lupus.Check my eligibility
What is being tested?
The study tests BIVV020's effectiveness in preventing and treating transplant rejection. It compares standard care treatments like Rituximab, IVIg, Tacrolimus, Corticosteroids, ATG, Mycophenolate with/without the addition of BIVV020.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as increased infection risk due to immunosuppression from medications like Tacrolimus and Corticosteroids. Specific side effects of BIVV020 will also be studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a kidney transplant recipient with active antibody-mediated rejection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to end of study, up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to end of study, up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort A: Treatment failure rate
Cohort B: AMR resolution rate
Secondary outcome measures
Assessment of adverse events (AEs)
Change in allograft histopathology Banff score
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)
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Standard of Care (SOC) Cohort BExperimental Treatment3 Interventions
SOC includes plasmapheresis, IVIg, corticosteroids, rituximab.
Group II: BIVV020 with Standard of Care (SOC) Cohort BExperimental Treatment4 Interventions
Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab.
Group III: BIVV020 with Standard of Care (SOC) Cohort AExperimental Treatment4 Interventions
Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Corticosteroids
2003
Completed Phase 4
~8270
Tacrolimus
2011
Completed Phase 4
~4740
Mycophenolate
2014
Completed Phase 4
~110

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,935 Total Patients Enrolled

Media Library

BIVV020 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05156710 — Phase 2
Transplant Rejection Research Study Groups: BIVV020 with Standard of Care (SOC) Cohort B, BIVV020 with Standard of Care (SOC) Cohort A, Standard of Care (SOC) Cohort B
Transplant Rejection Clinical Trial 2023: BIVV020 Highlights & Side Effects. Trial Name: NCT05156710 — Phase 2
BIVV020 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05156710 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must a participant have in order to join this scientific endeavor?

"Eligible candidates for this study must have received a rejection or transplant and be between 18-75 years old. The total number of accepted participants is 54."

Answered by AI

What is the upper limit for participants in this research endeavor?

"Affirmative. Clinicaltrials.gov details this medical study is actively seeking volunteers, which was initially published on June 9th 2022 and modified lastly in October 26th 2022. 54 individuals are needed to be enrolled from 3 distinct centers of care."

Answered by AI

Has recruitment for this trial already begun?

"According to clinicaltrials.gov, this medical trial is accepting applicants at present. The protocol was initially made public on June 9th 2022 and has been amended as recently as October 26th of the same year."

Answered by AI

Does this investigation accept elderly participants aged over 80 years?

"Applicants must fall within the 18-75 age bracket in order to fulfill the eligibility requirements of this clinical trial."

Answered by AI

Has the United States Food and Drug Administration given its endorsement to Rituximab?

"The safety of Rituximab was appraised at 2 due to the clinical data that supported its security, yet no evidence existed for its efficacy."

Answered by AI

What is the principal use of Rituximab?

"Rituximab is an effective therapeutic agent for dermatitis, atopic conditions, B-cell lymphomas and polyangium."

Answered by AI

Can you provide details of past experiments that have employed Rituximab?

"Rituximab was initially studied in 1993 at the NIH's Clinical Center. As of now, there are 1540 completed studies and 583 ongoing ones; numerous research sites located in Vancouver, British Columbia have been actively recruiting participants for these trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)
2022. "BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05156710.
~9 spots leftby Nov 2024
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