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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05983770




Registration number
NCT05983770
Ethics application status
Date submitted
2/08/2023
Date registered
9/08/2023

Titles & IDs
Public title
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
Scientific title
AT-1501-K207: BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
Secondary ID [1] 0 0
2023-503336-41-00
Secondary ID [2] 0 0
AT-1501-K207
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AT-1501
Treatment: Drugs - Tacrolimus

Experimental: Investigative - AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

Active comparator: Comparator - Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter


Treatment: Drugs: AT-1501
IV infusions of AT-1501 20 mg/kg over 1 hour.

Treatment: Drugs: Tacrolimus
Tacrolimus will be administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
eGFR at 12 months
Timepoint [1] 0 0
Assessed from date of transplant through Day 364 (Month 12)
Secondary outcome [1] 0 0
NODAT at 12 months post-transplant
Timepoint [1] 0 0
Assessed from date of transplant through Day 364 (Month 12
Secondary outcome [2] 0 0
The proportion of patient and graft survival at 12 months post-transplant
Timepoint [2] 0 0
Assessed from date of transplant through Day 364 (Month 12)
Secondary outcome [3] 0 0
BPAR-free patient and graft survival at 12 months post-transplant
Timepoint [3] 0 0
The proportion of BPAR-free patient and graft survival at 12 months post-transplant
Secondary outcome [4] 0 0
BPAR at 12 months
Timepoint [4] 0 0
Assessed from date of transplant through Day 364 (Month 12)

Eligibility
Key inclusion criteria
* Male or female = 18 years of age
* Recipient of their first kidney transplant from a living or deceased donor
* Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen
* Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies
* Currently treated with corticosteroids other than topical or inhaled corticosteroids
* Will receive a kidney with an anticipated cold ischemia time of > 30 hours
* Will receive a kidney from a donor that meets any of the following:

* 5a. Donation after Cardiac Death (DCD) criteria; Or
* 5b. Kidney Donor Profile Index (KDPI) of > 85%; Or
* 5c. Is blood group (ABO) incompatible
* Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants
* History of a thromboembolic event, known hypercoagulable state, or condition requiring long term anticoagulation
* Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening

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
30/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6150 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Texas
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Virginia
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Washington
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United States of America
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Wisconsin
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Brazil
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São Paulo
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Canada
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Alberta
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Canada
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British Columbia
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France
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Bois-Guillaume
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France
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Bordeaux
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France
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Créteil
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France
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Grenoble
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France
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Limoges
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France
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Toulouse
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France
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Tours
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Germany
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Berlin
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Spain
State/province [37] 0 0
Barcelona

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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
Eledon Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
949-238-8090
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05983770