Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)
NCT ID: NCT05125068
Last Updated: 2024-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
24 participants
INTERVENTIONAL
2022-03-21
2023-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
NCT06291376
A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy
NCT04663204
Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade
NCT02384317
Rituximab to Prevent Recurrence of Proteinuria
NCT01164098
Longterm Renal Oucomes of STOP-IgAN Trial Participants
NCT03488368
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
AT-1501
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
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
AT-1501
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AT-1501
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eledon Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Liverpool Hospital
Liverpool, South Wales, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Western Health
St Albans, Victoria, Australia
University Hospital Centre Sisters of Charity
Zagreb, , Croatia
University Hospital Dubrava Zagreb
Zagreb, , Croatia
University Malaya Medical Centre (UMMC)
Kuala Lumpur, Kuala Lumpur WP, Malaysia
Hospital Tengku Ampuan Afzan (HTAA)
Kuantan, Pahang, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, Malaysia
Hospital Kajang
Kajang, Selangor, Malaysia
Hospital Serdang
Kajang, Selangor, Malaysia
Waikato Hospital
Hamilton, , New Zealand
Hawke's Bay Hospital
Hastings, , New Zealand
University of Santo Tomas Hospital
Sampaloc, Manila, Philippines
Medical University of Bialystok UI
Bialystok, , Poland
Specjalistyczne Centrum Medyczne, SCM Spółka
Krakow, , Poland
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Virgen de la Macarena
Seville, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
National Hospital of Sri Lanka
Colombo, , Sri Lanka
Sri Jayawardanepura General Hospital
Nugegoda, , Sri Lanka
Prince of Songkla University
Dusit, Bangkok, Thailand
Chulalongkorn University
Pathum Wan, Bangkok, Thailand
Phramongkutklao Hospital
Bangkok, , Thailand
Chiang Mai University
Chiang Mai, , Thailand
Kings College Hospital
Camberwell, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-004795-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1269-7356
Identifier Type: OTHER
Identifier Source: secondary_id
AT-1501-N205
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.