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

March 25, 2024 updated by: Eledon Pharmaceuticals

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Wales
      • Liverpool, South Wales, Australia, NSW 2170
        • Liverpool Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • St Albans, Victoria, Australia
        • Western Health
  • Croatia
      • Zagreb, Croatia
        • University Hospital Centre Sisters of Charity
      • Zagreb, Croatia
        • University Hospital Dubrava Zagreb
  • Malaysia
    • Kuala Lumpur WP
      • Kuala Lumpur, Kuala Lumpur WP, Malaysia, 59100
        • University Malaya Medical Centre (UMMC)
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Hospital Tengku Ampuan Afzan (HTAA)
    • Sabah
      • Kota Kinabalu, Sabah, Malaysia
        • Hospital Queen Elizabeth
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Hospital Kajang
      • Kajang,, Selangor, Malaysia, 43000
        • Hospital Serdang
  • New Zealand
      • Hamilton, New Zealand, 3204
        • Waikato Hospital
      • Hastings, New Zealand, 4120
        • Hawke's Bay Hospital
  • Philippines
    • Manila
      • Sampaloc, Manila, Philippines
        • University of Santo Tomas Hospital
  • Poland
      • Białystok, Poland
        • Medical University of Bialystok UI
      • Krakow, Poland
        • Specjalistyczne Centrum Medyczne, SCM Spółka
  • Spain
      • Madrid, Spain
        • Hospital Clínico San Carlos
      • Sevilla, Spain
        • Hospital Virgen de la Macarena
      • Zaragoza, Spain
        • Hospital Universitario Miguel Servet
    • Valencia
      • Sagunto, Valencia, Spain
        • Hospital de Sagunto
  • Sri Lanka
      • Colombo, Sri Lanka, 01000
        • National Hospital of Sri Lanka
      • Nugegoda, Sri Lanka, 10250
        • Sri Jayawardanepura General Hospital
  • Thailand
      • Bangkok, Thailand
        • Phramongkutklao Hospital
      • Chiang Mai, Thailand
        • Chiang Mai University
    • Bangkok
      • Dusit, Bangkok, Thailand
        • Prince of Songkla University
      • Pathum Wan, Bangkok, Thailand, 10330
        • Chulalongkorn University
  • United Kingdom
      • Camberwell, United Kingdom
        • Kings College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
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
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Experimental: Arm B
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
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - change in participants UPCR
Time Frame: Up to 24 weeks
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
Time Frame: 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)
Through study completion, an average of 100 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in eGFR slope
Time Frame: Baseline- 96 weeks
The change in eGFR slope from baseline to 96 weeks
Baseline- 96 weeks
Change in urine protein excretion (mg/mg)
Time Frame: Up to 96 weeks
The change in urine protein excretion over time
Up to 96 weeks
Development of Anti drug Antibodies (ADAs)
Time Frame: Up to 96 weeks
The percentage of participants who develop ADAs
Up to 96 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory- Change in baseline serum biomarkers
Time Frame: Through study completion, an average of 100 weeks
The change in serum biomarkers from baseline to completion of study
Through study completion, an average of 100 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eledon Pharmaceuticals

Investigators

  • Study Chair: Jeffrey Bornstein, MD, Eledon Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-1501-N205
  • 2021-004795-34 (EudraCT Number)
  • U1111-1269-7356 (Other Identifier: Universal Trial Number (UTN))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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