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SLCTR Registration Number
SLCTR/2022/010
Date of Registration
The date of last modification
Oct 04, 2024
View original TRDS
Scientific Title of Trial
A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients with IgA Nephropathy
Public Title of Trial
A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients with IgA Nephropathy
Disease or Health Condition(s) Studied
IgA Nephropathy (IgAN)
Scientific Acronym
AT-1501-N205
Public Acronym
AT-1501-N205
Brief title
Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)
Universal Trial Number
U1111-1269-7356
Any other number(s) assigned to the trial and issuing authority
Clinicaltrials.gov. Identifier: NCT05125068 EudraCT Number: 2021-004795-34
What is the research question being addressed?
What is the safety and efficacy of AT-1501 in Patients with IgA Nephropathy?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Sequential
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
Study setting: Sri Jayewardenepura General Hospital, National Hospital of Sri Lanka, The National Institute of Nephrology, Dialysis and Transplantation and Colombo North Teaching Hospital.
Study drug - AT-1501 for injection is lyophilized at 20 mg/mL in 25 mM histidine-HCl, pH 6.5, 225 mM sucrose, 0.02% (w/v) polysorbate 20, and appears as a white to off-white cake. Unit strength is 190 mg / vial. Globally, up to 42 eligible patients will receive AT-1501 and be treated in a 2-stage design to evaluate 2 independent dose cohorts of 21 patients each at 5 and 10 mg/kg. The cohorts will be dosed sequentially with the 10 mg/kg cohort being dosed first. In Cohort 1, 21 patients will receive AT-1501 10 mg/kg every 3 weeks for up to 93 weeks for a total of 32 infusions. The treatment period is defined as Day1 through Week 96, with the last infusion being administered on Week 93 and a 3-week follow-up visit at Week 96. After enrolment to Cohort 1 has been completed, enrolment to Cohort 2, 5 mg/kg, will be initiated. Cohort 2 will follow the same dosing regimen and assessment schedule as Cohort 1
Inclusion criteria
Exclusion criteria
Primary outcome(s)
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1.
Efficacy: Change in 24 hour urine protein to creatinine ratio (UPCR) participants |
[ Time Frame: Up to 24 weeks ] |
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2.
Safety: Number of participants with treatment related serious adverse events, treatment emergent adverse events (TEAE’s) and AE’s of special interest (AEoSI) which include: • Anaphylaxis • Any thromboembolic (TE) event • Bleeding • Fungal and opportunistic infections • Malignancy |
[ Time Frame: Through study completion, an average of 100 weeks ] |
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3.
Safety: Changes in vital signs, electrocardiogram changes (ECG) and clinical laboratory measures |
[ Time Frame: Through study completion, an average of 100 weeks ] |
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4.
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5.
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Secondary outcome(s)
|
1.
Change in eGFR slope |
[ Time Frame: Baseline- 96 weeks ] |
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2.
Change in urine protein excretion (mg/mg) |
[ Time Frame: Up to 96 weeks ] |
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3.
Development of Anti drug Antibodies (ADAs) |
[ Time Frame: Up to 96 weeks ] |
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4.
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5.
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Target number/sample size
Total of 42 in two 21 dose cohorts; Global: 42, Sri Lanka: 4
Countries of recruitment
Australia, China, Croatia, Malaysia, New Zealand, Philippines, Poland, Spain, Sri Lanka, Thailand, United Kingdom, United States
Anticipated start date
2022-05-25
Anticipated end date
2025-04-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Eledon Pharmaceuticals, Inc. 19900 MacArthur Blvd., Suite 550 Irvine, California 92612, USA
Regulatory approvals
National Medicine Regulatory Authority (NMRA) Sri Lanka- Approval Pending
Status
Approved
Date of Approval
2022-03-08
Approval number
P/04/01/2022
Details of Ethics Review Committee
| Name: | Ethics Review Committee Faculty of Medicine University of Kelaniya |
| Institutional Address: | Ethics Review Committee University of Kelaniya, P.O Box 6, Thalagolla Road, Ragama, Sri Lanka |
| Telephone: | +94 11 2961267 |
| Email: | ercmed@kln.ac.lk |
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
N/A
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
