Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05156710




Registration number
NCT05156710
Ethics application status
Date submitted
18/11/2021
Date registered
14/12/2021
Date last updated
1/11/2024

Titles & IDs
Public title
BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)
Scientific 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.
Secondary ID [1] 0 0
U1111-1267-2612
Secondary ID [2] 0 0
ACT17012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transplant Rejection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: BIVV020 with Standard of Care (SOC) Cohort A - Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate.
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
-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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who are ABO incompatible with their donors.
* Participants with known active ongoing infection as per below:

1. Positive HIV.
2. Positive HBV.
3. HCV with detectable HCV RNA.
4. 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.
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/12/2026
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 kidney transplant participants
* To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants
* To evaluate the immunogenicity of BIVV020
Trial website
https://clinicaltrials.gov/study/NCT05156710
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free number for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05156710