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

Last updated: March 25, 2024
Sponsor: Eledon Pharmaceuticals
Overall Status: Terminated

Phase

2

Condition

Nephropathy

Kidney Disease

Glomerulonephritis

Treatment

AT-1501

Clinical Study ID

NCT05125068
AT-1501-N205
U1111-1269-7356
2021-004795-34
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 inhibitorsor 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 1.73m2 with a kidney biopsy within 2 years of Screening showing < 50% tubulointerstitialfibrosis
  5. Agree to comply with contraception requirements during and for 90 days after studycompletion.

Exclusion

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 ScreeningVisit. Patients must be on a stable dose and regimen of an ACE inhibitor or ARB for atleast 90 days
  6. Pregnancy or breastfeeding.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: AT-1501
Phase: 2
Study Start date:
March 21, 2022
Estimated Completion Date:
July 31, 2023

Study 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.

Connect with a study center

  • Liverpool Hospital

    Liverpool, South Wales NSW 2170
    Australia

    Site Not Available

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Western Health

    St Albans, Victoria
    Australia

    Site Not Available

  • University Hospital Centre Sisters of Charity

    Zagreb,
    Croatia

    Site Not Available

  • University Hospital Dubrava Zagreb

    Zagreb,
    Croatia

    Site Not Available

  • University Malaya Medical Centre (UMMC)

    Kuala Lumpur, Kuala Lumpur WP 59100
    Malaysia

    Site Not Available

  • Hospital Tengku Ampuan Afzan (HTAA)

    Kuantan, Pahang 25100
    Malaysia

    Site Not Available

  • Hospital Queen Elizabeth

    Kota Kinabalu, Sabah
    Malaysia

    Site Not Available

  • Hospital Kajang

    Kajang, Selangor 43000
    Malaysia

    Site Not Available

  • Hospital Serdang

    Kajang,, Selangor 43000
    Malaysia

    Site Not Available

  • Waikato Hospital

    Hamilton, 3204
    New Zealand

    Site Not Available

  • Hawke's Bay Hospital

    Hastings, 4120
    New Zealand

    Site Not Available

  • University of Santo Tomas Hospital

    Sampaloc, Manila
    Philippines

    Site Not Available

  • Medical University of Bialystok UI

    Białystok,
    Poland

    Site Not Available

  • Specjalistyczne Centrum Medyczne, SCM Spółka

    Krakow,
    Poland

    Site Not Available

  • Hospital Público da Mariña

    Burela De Cabo, Lugo
    Spain

    Site Not Available

  • Hospital de Sagunto

    Sagunto, Valencia
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid,
    Spain

    Site Not Available

  • Hospital Virgen de la Macarena

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza,
    Spain

    Site Not Available

  • National Hospital of Sri Lanka

    Colombo, 01000
    Sri Lanka

    Site Not Available

  • Sri Jayawardanepura General Hospital

    Nugegoda, 10250
    Sri Lanka

    Site Not Available

  • Prince of Songkla University

    Dusit, Bangkok
    Thailand

    Site Not Available

  • Chulalongkorn University

    Pathum Wan, Bangkok 10330
    Thailand

    Site Not Available

  • Phramongkutklao Hospital

    Bangkok,
    Thailand

    Site Not Available

  • Chiang Mai University

    Chiang Mai,
    Thailand

    Site Not Available

  • Kings College Hospital

    Camberwell,
    United Kingdom

    Site Not Available

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