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

Primary Purpose

IgA Nephropathy, IgAN

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AT-1501
Sponsored by
Eledon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring IgA Nephropathy, IgAN, AT-1501, CD40L, Monoclonal antibody, Proteinuria, eGFR, UPCR

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Liverpool HospitalRecruiting
  • Monash Medical CentreRecruiting
  • Western HealthRecruiting
  • University Hospital Centre Sisters of CharityRecruiting
  • University Hospital Dubrava ZagrebRecruiting
  • University Malaya Medical Centre (UMMC)Recruiting
  • Hospital Tengku Ampuan Afzan (HTAA)Recruiting
  • Hospital Queen ElizabethRecruiting
  • Hospital SerdangRecruiting
  • Hospital KajangRecruiting
  • Waikato HospitalRecruiting
  • Hawke's Bay HospitalRecruiting
  • University of Santo Tomas HospitalRecruiting
  • Medical University of Bialystok UIRecruiting
  • Specjalistyczne Centrum Medyczne, SCM SpółkaRecruiting
  • Hospital de SaguntoRecruiting
  • Hospital Clinico San CarlosRecruiting
  • Hospital Virgen de la MacarenaRecruiting
  • Hospital Universitario Miguel ServetRecruiting
  • National Hospital of Sri LankaRecruiting
  • Sri Jayawardanepura General HospitalRecruiting
  • Prince of Songkla UniversityRecruiting
  • Chulalongkorn UniversityRecruiting
  • Phramongkutklao HospitalRecruiting
  • Chiang Mai UniversityRecruiting
  • Kings College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in eGFR slope
The change in eGFR slope from baseline to 96 weeks
Change in urine protein excretion (mg/mg)
The change in urine protein excretion over time
Development of Anti drug Antibodies (ADAs)
The percentage of participants who develop ADAs

Full Information

First Posted
November 8, 2021
Last Updated
August 17, 2023
Sponsor
Eledon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05125068
Brief Title
Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)
Official Title
A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eledon Pharmaceuticals

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy, IgAN
Keywords
IgA Nephropathy, IgAN, AT-1501, CD40L, Monoclonal antibody, Proteinuria, eGFR, UPCR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
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 Title
Arm B
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
AT-1501
Intervention Description
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Primary Outcome Measure Information:
Title
Efficacy - change in participants UPCR
Description
The change in 24-hour urine protein to creatinine ratio (UPCR) from baseline to 24 weeks
Time Frame
Up to 24 weeks
Title
Safety- Number of participants with treatment related adverse events
Description
Incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs of special interest (AEoSI)
Time Frame
Through study completion, an average of 100 weeks
Secondary Outcome Measure Information:
Title
Change in eGFR slope
Description
The change in eGFR slope from baseline to 96 weeks
Time Frame
Baseline- 96 weeks
Title
Change in urine protein excretion (mg/mg)
Description
The change in urine protein excretion over time
Time Frame
Up to 96 weeks
Title
Development of Anti drug Antibodies (ADAs)
Description
The percentage of participants who develop ADAs
Time Frame
Up to 96 weeks
Other Pre-specified Outcome Measures:
Title
Exploratory- Change in baseline serum biomarkers
Description
The change in serum biomarkers from baseline to completion of study
Time Frame
Through study completion, an average of 100 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eledon Pharmacueticals
Phone
949-238-8090
Email
clinicaltrials@eledon.com
Facility Information:
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
South Wales
ZIP/Postal Code
NSW 2170
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Research Staff
Facility Name
Western Health
City
St Albans
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
University Hospital Centre Sisters of Charity
City
Zagreb
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
University Hospital Dubrava Zagreb
City
Zagreb
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
University Malaya Medical Centre (UMMC)
City
Kuala Lumpur
State/Province
Kuala Lumpur WP
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Hospital Tengku Ampuan Afzan (HTAA)
City
Kuantan
State/Province
Pahang
ZIP/Postal Code
25100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Hospital Queen Elizabeth
City
Kota Kinabalu
State/Province
Sabah
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Hospital Serdang
City
Kajang,
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Hospital Kajang
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Hawke's Bay Hospital
City
Hastings
ZIP/Postal Code
4120
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
University of Santo Tomas Hospital
City
Sampaloc
State/Province
Manila
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Medical University of Bialystok UI
City
Białystok
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Specjalistyczne Centrum Medyczne, SCM Spółka
City
Krakow
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Hospital de Sagunto
City
Sagunto
State/Province
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Hospital Virgen de la Macarena
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
National Hospital of Sri Lanka
City
Colombo
ZIP/Postal Code
01000
Country
Sri Lanka
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Sri Jayawardanepura General Hospital
City
Nugegoda
ZIP/Postal Code
10250
Country
Sri Lanka
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Prince of Songkla University
City
Dusit
State/Province
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Chulalongkorn University
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Phramongkutklao Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Chiang Mai University
City
Chiang Mai
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff
Facility Name
Kings College Hospital
City
Camberwell
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Study Staff

12. IPD Sharing Statement

Learn more about this trial

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

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