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Clinical Trials/2023-503336-41-00
2023-503336-41-00
Recruiting
Phase 2

BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

Eledon Pharmaceuticals Inc.14 sites in 3 countries101 target enrollmentStarted: October 30, 2023Last updated:
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Overview

Phase
Phase 2
Status
Recruiting
Enrollment
101
Locations
14
Primary Endpoint
The mean estimated glomerular filtration rate (eGFR) at 12 months.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To assess the graft function at 12 months post-transplant in tegoprubart treated participants compared to tacrolimus treated participants.

Study Design

Allocation
Randomized
Primary Purpose
Post-transplant Treatment (Day 1 through Month 12, or Month 13)
Masking
None

Eligibility Criteria

Ages
18 years to 64 years (18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Participants meeting all of the following criteria at the time of Screening will be considered for admission to the study: Able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent;
  • •Male or female ≥ 18 years of age;
  • •Recipient of their first kidney transplant from a living or deceased donor;
  • •Willing and able to comply with the study requirements including prohibited concomitant medication restrictions;
  • •Agree not to participate in another interventional study while on treatment;
  • •If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a serum pregnancy test is negative at screening/baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from Screening, through 120 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table
  • •If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 120 days after last administration of the study drug and agree to not donate sperm for 120 days after last administration of the study drug;

Exclusion Criteria

  • •A patient who meets any of the following criteria will be excluded from this study: Induction therapy, other than study-assigned rATG, planned as part of initial immunosuppressive regimen;
  • •Known hypersensitivity to tegoprubart, tacrolimus, mycophenolate, rATG, corticosteroids, or any of their components;
  • •Active substance abuse within 1 year prior to Screening;
  • •Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies;
  • •Clinically significant abnormal ECG at Screening;
  • •Recipient is seronegative for EBV at Screening;
  • •Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening;
  • •Thrombocytopenia (platelets < 75,000 per mm 3), leukopenia (white blood cells [WBC] < 3,000 per mm 3), or anemia (hemoglobin < 8 g/dL) at Screening;
  • •Desensitization therapy within 6 months of transplant;
  • •Pregnancy or breastfeeding;

Outcomes

Primary Outcomes

The mean estimated glomerular filtration rate (eGFR) at 12 months.

The mean estimated glomerular filtration rate (eGFR) at 12 months.

Secondary Outcomes

  • The rate of graft functional impairment at 12 months. A participant is considered to have graft functional impairment if they either: A) Have an eGFR <60 mL/min/1.73m2 or B) Have a decrease in eGFR ≥ 10 mL/min/1.73m2 from Month 1 to Month 12;
  • The rate of NODAT at 12 months post-transplant;
  • The rate 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;
  • Rate of BPAR-free patient and graft survival at 12 months post-transplant;
  • Rate of BPAR at 12 months.

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Chief Regulatory Officer

Scientific

Eledon Pharmaceuticals Inc.

Study Sites (14)

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