Clinical trial NCT05125068: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: IgA Nephropathy
IgAN
Keywords: IgA Nephropathy
IgAN
AT-1501
CD40L
Monoclonal antibody
Proteinuria
eGFR
UPCR
Lead sponsor: Eledon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-11-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy - change in participants UPCR
timeFrame: Up to 24 weeks
measure: Safety- Number of participants with treatment related adverse events
timeFrame: Through study completion, an average of 100 weeks
Secondary outcomes:
measure: Change in eGFR slope
timeFrame: Baseline- 96 weeks
measure: Change in urine protein excretion (mg/mg)
timeFrame: Up to 96 weeks
measure: Development of Anti drug Antibodies (ADAs)
timeFrame: Up to 96 weeks
Other outcomes:
measure: Exploratory- Change in baseline serum biomarkers
timeFrame: Through study completion, an average of 100 weeks
Locations:
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: South Wales
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: St Albans
country: Australia
facility: Western Health
state: Victoria
city: Zagreb
country: Croatia
facility: University Hospital Centre Sisters of Charity
city: Zagreb
country: Croatia
facility: University Hospital Dubrava Zagreb
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre (UMMC)
state: Kuala Lumpur WP
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan (HTAA)
state: Pahang
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth
state: Sabah
city: Kajang,
country: Malaysia
facility: Hospital Serdang
state: Selangor
city: Kajang
country: Malaysia
facility: Hospital Kajang
state: Selangor
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Hastings
country: New Zealand
facility: Hawke's Bay Hospital
city: Sampaloc
country: Philippines
facility: University of Santo Tomas Hospital
state: Manila
city: Białystok
country: Poland
facility: Medical University of Bialystok UI
city: Krakow
country: Poland
facility: Specjalistyczne Centrum Medyczne, SCM Spółka
city: Sagunto
country: Spain
facility: Hospital de Sagunto
state: Valencia
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Colombo
country: Sri Lanka
facility: National Hospital of Sri Lanka
city: Nugegoda
country: Sri Lanka
facility: Sri Jayawardanepura General Hospital
city: Dusit
country: Thailand
facility: Prince of Songkla University
state: Bangkok
city: Pathum Wan
country: Thailand
facility: Chulalongkorn University
state: Bangkok
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
city: Camberwell
country: United Kingdom
facility: Kings College Hospital
Study officials:
References: