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Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

PHASE1PHASE2RECRUITING

This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.

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Study details:

This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation. Up to 24 de novo kidney transplant recipients will receive AT-1501 in combination with rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy.

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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, with the exception of 5 mg prednisone or equivalent daily;

Previous treatment with AT 1501 or any other anti CD40LG therapy

The patient has previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi organ or dual kidney transplant

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: • Donation after Cardiac Death (DCD) criteria; or Extended Criteria Donor (ECD) criteria, defined as: * Is blood group (ABO) incompatible; or * Age ≥ 60 years; or * Age 50-59 years with any 2 of the following criteria * Death due to cerebrovascular accident * History of hypertension * Terminal creatinine ≥ 133 μmol/L

Human leukocyte antigen identical (two haplotype match or zero HLA mismatch) donor

Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day

History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation: 1. Patients with a history of clotted venous access not requiring long term anticoagulation may be included at the Investigator's discretion if have no other history of TE events or known hypercoagulable state

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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: 2022-02-18

Primary completion: 2025-09-01

Study completion finish: 2025-09-01

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT05027906

Intervention or treatment

DRUG: AT-1501

Conditions

• Kidney Transplant

Condition: Kidney Transplant
DRUG: AT-1501
Adelaide, South Australia, Australia
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

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Royal Adelaide Hospital
Adelaide, South 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: AT-1501 Single Arm AT-1501 monoclonal antibody targeting CD40L given as an IV infusion	DRUG: AT-1501 Investigative Arm

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Safety Incidences	Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs)	Through study completion, an average up to 20 months
Pharmacokinetic- PK profile	PK profile of the first dose of AT 1501 and at steady state Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (Ct), calculated using noncompartmental analysis (AUC0-t)	Day 1 and at steady state Month 3
Pharmacokinetic- Area under the plasma concentration	Area under the plasma concentration versus time curve from time 0 extrapolated to infinity, calculated using noncompartmental analysis (AUC0-inf)	Day 1 and at steady state Month 3
Pharmacokinetic- Cmax	Maximum observed plasma concentration (Cmax)	Day 1 and at steady state Month 3
Pharmacokinetic- Tmax	Time to reach maximum observed plasma concentration (Tmax)	Day 1 and at steady state Month 3
Pharmacokinetic- Ke	Terminal elimination rate constant (Ke)	Day 1 and at steady state Month 3
Pharmacokinetic- (t1/2)	Terminal phase half-life (t1/2)	Day 1 and at steady state Month 3
Pharmacokinetic- CL	Clearance (CL)	Day 1 and at steady state Month 3
Pharmacokinetic- (Vdss)	Volume of distribution at steady state (Vdss)	Day 1 and at steady state Month 3

Secondary outcome

Frequently Asked Questions

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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, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant