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Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

Primary Purpose

Kidney Transplant Rejection

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AT-1501
Tacrolimus
Sponsored by
Eledon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Transplant Rejection focused on measuring AT-1501, Kidney Transplant, Renal Allograft Rejection, Prophylaxis, CD40L Inhibitor, Humanized blocking antibody to CD40L, Monoclonal Antibody, Renal, Transplant, ESRD, Tegoprubart

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 6. Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants 7. History of a thromboembolic event, known hypercoagulable state, or condition requiring long term anticoagulation 8. Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening

Sites / Locations

  • Washington University in St. LouisRecruiting
  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigative

Comparator

Arm Description

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

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

Outcomes

Primary Outcome Measures

eGFR at 12 months
Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant

Secondary Outcome Measures

NODAT at 12 months post-transplant
The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant
The proportion of patient and graft survival at 12 months post-transplant
Patient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysis
BPAR-free patient and graft survival at 12 months post-transplant
Assessed from date of transplant through Day 364 (Month 12)
BPAR at 12 months
The proportion of BPAR at 12 months

Full Information

First Posted
August 2, 2023
Last Updated
August 2, 2023
Sponsor
Eledon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05983770
Brief Title
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eledon Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
Detailed Description
This study is a randomized, multicenter, open-label, active control study to evaluate the safety and efficacy of AT-1501 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1 to receive either AT-1501 or tacrolimus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant Rejection
Keywords
AT-1501, Kidney Transplant, Renal Allograft Rejection, Prophylaxis, CD40L Inhibitor, Humanized blocking antibody to CD40L, Monoclonal Antibody, Renal, Transplant, ESRD, Tegoprubart

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigative
Arm Type
Experimental
Arm Description
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter
Intervention Type
Drug
Intervention Name(s)
AT-1501
Other Intervention Name(s)
Tegoprubart
Intervention Description
IV infusions of AT-1501 20 mg/kg over 1 hour.
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Intervention Description
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.
Primary Outcome Measure Information:
Title
eGFR at 12 months
Description
Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant
Time Frame
Assessed from date of transplant through Day 364 (Month 12)
Secondary Outcome Measure Information:
Title
NODAT at 12 months post-transplant
Description
The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant
Time Frame
Assessed from date of transplant through Day 364 (Month 12
Title
The proportion of patient and graft survival at 12 months post-transplant
Description
Patient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysis
Time Frame
Assessed from date of transplant through Day 364 (Month 12)
Title
BPAR-free patient and graft survival at 12 months post-transplant
Description
Assessed from date of transplant through Day 364 (Month 12)
Time Frame
The proportion of BPAR-free patient and graft survival at 12 months post-transplant
Title
BPAR at 12 months
Description
The proportion of BPAR at 12 months
Time Frame
Assessed from date of transplant through Day 364 (Month 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 6. Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants 7. History of a thromboembolic event, known hypercoagulable state, or condition requiring long term anticoagulation 8. Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eledon Pharmaceuticals
Phone
949-238-8090
Email
clinicaltrials@eledon.com
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

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