Clinical trial NCT05027906: Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
Official title: A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Kidney Transplant
Keywords: Kidney Transplant
Renal Allograft Rejection
Prophylaxis
AT-1501
CD40L inhibitor
Humanized blocking antibody to CD40L
Monoclonal Antibody
Renal
Transplant
ESRD
tegoprubart
Lead sponsor: Eledon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase 1b, open label, single-arm study
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female ≥ 18 years of age
2. Recipient of their first kidney transplant from a living or deceased donor
3. Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug

Exclusion Criteria:

1. Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen
2. Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies, with the exception of 5 mg prednisone or equivalent daily;
3. Previous treatment with AT 1501 or any other anti CD40LG therapy
4. 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
5. Will receive a kidney with an anticipated cold ischemia time of \> 30 hours;
6. 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
7. Human leukocyte antigen identical (two haplotype match or zero HLA mismatch) donor
8. Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day
9. 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

Primary outcomes:
measure: Safety Incidences
timeFrame: Through study completion, an average up to 20 months
measure: Pharmacokinetic- PK profile
timeFrame: Day 1 and at steady state Month 3
measure: Pharmacokinetic- Area under the plasma concentration
timeFrame: Day 1 and at steady state Month 3
measure: Pharmacokinetic- Cmax
timeFrame: Day 1 and at steady state Month 3
measure: Pharmacokinetic- Tmax
timeFrame: Day 1 and at steady state Month 3
measure: Pharmacokinetic- Ke
timeFrame: Day 1 and at steady state Month 3
measure: Pharmacokinetic- (t1/2)
timeFrame: Day 1 and at steady state Month 3
measure: Pharmacokinetic- CL
timeFrame: Day 1 and at steady state Month 3
measure: Pharmacokinetic- (Vdss)
timeFrame: Day 1 and at steady state Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: São Paulo
country: Brazil
facility: Fundação Oswaldo Ramos - Hospital do Rim
city: Vancouver
country: Canada
facility: Providence Health Care - St. Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Montréal
country: Canada
facility: McGill University Health Care Centre
state: Quebec
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital
Study officials:
References: