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

NCT05125068 | Terminated Phase 2 DMC

• 3 other identifiers: AT-1501-N2052021-004795-34U1111-1269-7356
• Study Type: interventional
• Target: 24
• Locations: 10 countries
• Sites: 26

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.

Conditions

IgA Nephropathy; IgAN

Keywords

IgA Nephropathy; IgAN; AT-1501; CD40L; Monoclonal antibody; Proteinuria; eGFR; UPCR

Outcome Measures

Primary Outcomes (2)

• Efficacy - change in participants UPCR

  The change in 24-hour urine protein to creatinine ratio (UPCR) from baseline to 24 weeks

  Up to 24 weeks

• Safety- Number of participants with treatment related adverse events

  Incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs of special interest (AEoSI)

  Through study completion, an average of 100 weeks

Secondary Outcomes (3)

• Change in eGFR slope

  Baseline- 96 weeks

• Change in urine protein excretion (mg/mg)

  Up to 96 weeks

• Development of Anti drug Antibodies (ADAs)

  Up to 96 weeks

Other Outcomes (1)

• Exploratory- Change in baseline serum biomarkers

  Through study completion, an average of 100 weeks

Study Arms (2)

Arm A

EXPERIMENTAL

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.

Drug: AT-1501

Arm B

EXPERIMENTAL

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

Drug: AT-1501

Interventions

AT-1501 DRUG

AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age
• Biopsy proven IgAN
• Urine protein ≥ 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB)
• 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
• Agree to comply with contraception requirements during and for 90 days after study completion.

You may not qualify if:

• Any secondary IgAN as defined by the investigator
• Patients who have undergone a kidney transplant
• Any history of kidney disease other than IgAN
• Any history of diabetes (Type 1 or Type 2)
• 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
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Eledon Pharmaceuticals: lead

Study Sites (26)

Liverpool Hospital

Liverpool, South Wales, NSW 2170, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Western Health

St Albans, Victoria, Australia

Location

University Hospital Centre Sisters of Charity

Zagreb, Croatia

Location

University Hospital Dubrava Zagreb

Zagreb, Croatia

Location

University Malaya Medical Centre (UMMC)

Kuala Lumpur, Kuala Lumpur WP, 59100, Malaysia

Location

Hospital Tengku Ampuan Afzan (HTAA)

Kuantan, Pahang, 25100, Malaysia

Location

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, Malaysia

Location

Hospital Kajang

Kajang, Selangor, 43000, Malaysia

Location

Hospital Serdang

Kajang, Selangor, 43000, Malaysia

Location

Waikato Hospital

Hamilton, 3204, New Zealand

Location

Hawke's Bay Hospital

Hastings, 4120, New Zealand

Location

University of Santo Tomas Hospital

Sampaloc, Manila, Philippines

Location

Medical University of Bialystok UI

Bialystok, Poland

Location

Specjalistyczne Centrum Medyczne, SCM Spółka

Krakow, Poland

Location

Hospital de Sagunto

Sagunto, Valencia, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Virgen de la Macarena

Seville, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

National Hospital of Sri Lanka

Colombo, 01000, Sri Lanka

Location

Sri Jayawardanepura General Hospital

Nugegoda, 10250, Sri Lanka

Location

Prince of Songkla University

Dusit, Bangkok, Thailand

Location

Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

Phramongkutklao Hospital

Bangkok, Thailand

Location

Chiang Mai University

Chiang Mai, Thailand

Location

Kings College Hospital

Camberwell, United Kingdom

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA; Proteinuria

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start: March 21, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

AU (3); MY (5); SR (2); CR (2); PH (1); GB (1); PL (2); TH (4); NZ (2); ES (4)