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.