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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05027906




Registration number
NCT05027906
Ethics application status
Date submitted
19/08/2021
Date registered
30/08/2021
Date last updated
12/11/2024

Titles & IDs
Public title
Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
Scientific title
A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
Secondary ID [1] 0 0
2021-003830-36
Secondary ID [2] 0 0
AT-1501-K102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplant 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AT-1501

Experimental: AT-1501 Single Arm - AT-1501 monoclonal antibody targeting CD40L given as an IV infusion


Treatment: Drugs: AT-1501
Investigative Arm
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety Incidences
Timepoint [1] 0 0
Through study completion, an average up to 20 months
Primary outcome [2] 0 0
Pharmacokinetic- PK profile
Timepoint [2] 0 0
Day 1 and at steady state Month 3
Primary outcome [3] 0 0
Pharmacokinetic- Area under the plasma concentration
Timepoint [3] 0 0
Day 1 and at steady state Month 3
Primary outcome [4] 0 0
Pharmacokinetic- Cmax
Timepoint [4] 0 0
Day 1 and at steady state Month 3
Primary outcome [5] 0 0
Pharmacokinetic- Tmax
Timepoint [5] 0 0
Day 1 and at steady state Month 3
Primary outcome [6] 0 0
Pharmacokinetic- Ke
Timepoint [6] 0 0
Day 1 and at steady state Month 3
Primary outcome [7] 0 0
Pharmacokinetic- (t1/2)
Timepoint [7] 0 0
Day 1 and at steady state Month 3
Primary outcome [8] 0 0
Pharmacokinetic- CL
Timepoint [8] 0 0
Day 1 and at steady state Month 3
Primary outcome [9] 0 0
Pharmacokinetic- (Vdss)
Timepoint [9] 0 0
Day 1 and at steady state Month 3

Eligibility
Key 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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
SA 5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eledon Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
Trial website
https://clinicaltrials.gov/study/NCT05027906
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Eledon Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
949-238-8090
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05027906