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Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

PHASE2RECRUITING

This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-08-30

Primary completion: 2025-03-01

Study completion finish: 2025-03-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05983770

Intervention or treatment

DRUG: AT-1501

DRUG: Tacrolimus

Conditions

• Kidney Transplant Rejection

Image related to Kidney Transplant Rejection

Condition: Kidney Transplant Rejection
DRUG: AT-1501 and other drugs
Adelaide, South Australia, Australia and more
Sponsor: Eledon Pharmaceuticals

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Adelaide Hospital

Research sites nearby

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, South Australia, Australia
Fiona Stanley Hospital
Perth, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Investigative AT-1501 monoclonal antibody targeting CD40L given as an IV infusion	DRUG: AT-1501 IV infusions of AT-1501 20 mg/kg over 1 hour.
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	DRUG: 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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
eGFR at 12 months	Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant	Assessed from date of transplant through Day 364 (Month 12)

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
NODAT at 12 months post-transplant	The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant	Assessed from date of transplant through Day 364 (Month 12
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	Assessed from date of transplant through Day 364 (Month 12)
BPAR-free patient and graft survival at 12 months post-transplant	Assessed from date of transplant through Day 364 (Month 12)	The proportion of BPAR-free patient and graft survival at 12 months post-transplant
BPAR at 12 months	The proportion of BPAR at 12 months	Assessed from date of transplant through Day 364 (Month 12)

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation