A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients with IgA Nephropathy

Phase 2

Conditions: IgA Nephropathy (IgAN)

Registration Number: SLCTR/2022/010

Lead Sponsor: Eledon Pharmaceuticals, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

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.Significant liver disease,;
7.Pregnancy or breastfeeding;
8.Concurrent participation in another interventional study or treatment with an investigational drug

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy:<br>Change in 24 hour urine protein to creatinine ratio (UPCR) participants [Time Frame: Up to 24 weeks ]<br> Safety:<br>Number of participants with treatment related serious adverse events, treatment emergent adverse events (TEAE’s) and AE’s of special interest (AEoSI) which include:<br>•Anaphylaxis<br>•Any thromboembolic (TE) event<br>•Bleeding<br>•Fungal and opportunistic infections<br>•Malignancy<br> [ Time Frame: Through study completion, an average of 100 weeks]<br> Safety:<br>Changes in vital signs, electrocardiogram changes (ECG) and clinical laboratory measures [ Time Frame: Through study completion, an average of 100 weeks]<br> []<br> []<br>

Secondary Outcome Measures

Name	Time	Method
Change in eGFR slope [Time Frame: Baseline- 96 weeks ]<br>Change in urine protein excretion (mg/mg) [ Time Frame: Up to 96 weeks ]<br>Development of Anti drug Antibodies (ADAs) [ Time Frame: Up to 96 weeks ]<br> []<br> []<br>