IgAN, IgA Nephropathy
Conditions
Keywords
IgA Nephropathy, IgAN, AT-1501, CD40L, Monoclonal antibody, Proteinuria, eGFR, UPCR
Brief summary
This is a phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening.
Detailed description
Phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of Screening. Up to 42 eligible patients will receive one of 2 doses of AT-1501. All patients are scheduled to receive AT-1501 by intravenous infusion every 3 weeks for approximately 2 years.
Interventions
DRUGAT-1501
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Sponsors
Eledon Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female ≥ 18 years of age 2. Biopsy proven IgAN 3. Urine protein ≥ 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB) 4. eGFR ≥ 45 mL/min per 1.73 m2 or eGFR \< 45 mL/min per 1.73 m2 and ≥ 30 mL/min per 1.73 m2 with a kidney biopsy within 2 years of Screening showing \< 50% tubulointerstitial fibrosis 5. Agree to comply with contraception requirements during and for 90 days after study completion.
Exclusion criteria
1. Any secondary IgAN as defined by the investigator 2. Patients who have undergone a kidney transplant 3. Any history of kidney disease other than IgAN 4. Any history of diabetes (Type 1 or Type 2) 5. Seated blood pressure \> 140 mmHg (systolic) or \> 90 mmHg (diastolic) at the Screening Visit. Patients must be on a stable dose and regimen of an ACE inhibitor or ARB for at least 90 days 6. Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - change in participants UPCR | Up to 24 weeks | The change in 24-hour urine protein to creatinine ratio (UPCR) from baseline to 24 weeks |
| Safety- Number of participants with treatment related adverse events | Through study completion, an average of 100 weeks | Incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs of special interest (AEoSI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in eGFR slope | Baseline- 96 weeks | The change in eGFR slope from baseline to 96 weeks |
| Change in urine protein excretion (mg/mg) | Up to 96 weeks | The change in urine protein excretion over time |
| Development of Anti drug Antibodies (ADAs) | Up to 96 weeks | The percentage of participants who develop ADAs |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory- Change in baseline serum biomarkers | Through study completion, an average of 100 weeks | The change in serum biomarkers from baseline to completion of study |
Countries
Australia, Croatia, Malaysia, New Zealand, Philippines, Poland, Spain, Sri Lanka, Thailand, United Kingdom
Outcome results
None listed