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

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05125068
• Other study ID #: AT-1501-N205
• Secondary ID: 2021-004795-34U1
• Status: Terminated
• Phase: Phase 2
• Start date: March 21, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2024
• Source: Eledon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• IgAN
• Kidney Diseases

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eledon Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Croatia,  Malaysia,  New Zealand,  Philippines,  Poland,  Spain,  Sri Lanka,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory- Change in baseline serum biomarkers	The change in serum biomarkers from baseline to completion of study	Through study completion, an average of 100 weeks
Primary	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
Primary	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	Change in eGFR slope	The change in eGFR slope from baseline to 96 weeks	Baseline- 96 weeks
Secondary	Change in urine protein excretion (mg/mg)	The change in urine protein excretion over time	Up to 96 weeks
Secondary	Development of Anti drug Antibodies (ADAs)	The percentage of participants who develop ADAs	Up to 96 weeks