Overview

Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)

Status:
Not yet recruiting
Trial end date:
2025-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eledon Pharmaceuticals
Criteria
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.