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

Phase 2

Terminated

• Conditions: IgA Nephropathy; IgAN
• Interventions: Drug: AT-1501

• Registration Number: NCT05125068
• Lead Sponsor: Eledon Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-11-18
• Study Start: 2022-03-21
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm A	AT-1501	AT-1501 10mg/kg Arm A will receive 10 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions.
Arm B	AT-1501	AT-1501 5mg/kg Arm B will receive 5 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (26)

Chulalongkorn University; 🇹🇭 Pathum Wan, Bangkok, Thailand

Prince of Songkla University; 🇹🇭 Dusit, Bangkok, Thailand

Monash Medical Centre; 🇦🇺 Clayton, Victoria, Australia

University of Santo Tomas Hospital; 🇵🇭 Sampaloc, Manila, Philippines

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand

University Hospital Dubrava Zagreb; 🇭🇷 Zagreb, Croatia

Hospital Serdang; 🇲🇾 Kajang,, Selangor, Malaysia

Western Health; 🇦🇺 St Albans, Victoria, Australia

University Hospital Centre Sisters of Charity; 🇭🇷 Zagreb, Croatia

University Malaya Medical Centre (UMMC); 🇲🇾 Kuala Lumpur, Kuala Lumpur WP, Malaysia

Chiang Mai University; 🇹🇭 Chiang Mai, Thailand

Hospital Tengku Ampuan Afzan (HTAA); 🇲🇾 Kuantan, Pahang, Malaysia

Specjalistyczne Centrum Medyczne, SCM Spółka; 🇵🇱 Krakow, Poland

Hawke's Bay Hospital; 🇳🇿 Hastings, New Zealand

Liverpool Hospital; 🇦🇺 Liverpool, South Wales, Australia

Hospital Queen Elizabeth; 🇲🇾 Kota Kinabalu, Sabah, Malaysia

Hospital Kajang; 🇲🇾 Kajang, Selangor, Malaysia

Waikato Hospital; 🇳🇿 Hamilton, New Zealand

Medical University of Bialystok UI; 🇵🇱 Białystok, Poland

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital de Sagunto; 🇪🇸 Sagunto, Valencia, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Virgen de la Macarena; 🇪🇸 Sevilla, Spain

National Hospital of Sri Lanka; 🇱🇰 Colombo, Sri Lanka

Sri Jayawardanepura General Hospital; 🇱🇰 Nugegoda, Sri Lanka

Kings College Hospital; 🇬🇧 Camberwell, United Kingdom