Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
Launched by ALPINE IMMUNE SCIENCES INC, A SUBSIDIARY OF VERTEX · Aug 19, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called povetacicept for adults with Immunoglobulin A Nephropathy (IgAN), a condition that affects the kidneys and can lead to kidney damage. The main goal of the study is to see if povetacicept can help reduce protein in the urine and protect kidney function compared to a placebo, which is a substance with no active medicine. The trial is currently recruiting participants who are between the ages of 65 and 74 and have been diagnosed with IgAN within the last 10 years. To qualify, participants need to have a specific level of protein in their urine and a certain level of kidney function.
If you decide to participate, you'll be closely monitored throughout the study, and you'll receive either the study medication or a placebo. It's important to note that you should not have received certain treatments like immunosuppressive drugs or undergone specific procedures recently to be eligible. This trial could be an opportunity to help advance our understanding of IgAN and potentially find new ways to treat it.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Diagnosed IgAN, with biopsy confirmation
- • 24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g
- • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2
- • Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification
- Key Exclusion Criteria:
- • Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol
- • Rapidly progressive glomerulonephritis with eGFR reduction \>50% within 12 weeks of the start of screening
- • Other protocol defined Inclusion/Exclusion criteria may apply.
About Alpine Immune Sciences Inc, A Subsidiary Of Vertex
Alpine Immune Sciences Inc., a subsidiary of Vertex Pharmaceuticals, is a clinical-stage biotechnology company dedicated to advancing innovative immunotherapies for the treatment of cancer and autoimmune diseases. Leveraging its proprietary platform, Alpine focuses on the development of novel biologics that harness the immune system's potential to address unmet medical needs. With a commitment to scientific excellence and patient-centered research, Alpine collaborates with leading researchers and institutions to drive the discovery and development of transformative therapies that enhance patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Burlington, Vermont, United States
London, , United Kingdom
Jamaica, New York, United States
Hong Kong, , Hong Kong
Cork, , Ireland
Baltimore, Maryland, United States
Uppsala, , Sweden
Philadelphia, Pennsylvania, United States
New York, New York, United States
Woolloongabba, Queensland, Australia
Rochester, Minnesota, United States
Concord, , Australia
Ashkelon, , Israel
Goteborg, , Sweden
Paris, , France
Tel Hashomer, , Israel
Santiago De Compostela, , Spain
Vienna, , Austria
Seoul, , Korea, Republic Of
Valencia, , Spain
Taipei, , Taiwan
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Bergen, , Norway
Galway, , Ireland
Groningen, , Netherlands
Daegu, , Korea, Republic Of
Aalborg, , Denmark
Zagreb, , Croatia
Daegu, , Korea, Republic Of
Suwon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Nijmegen, , Netherlands
Madrid, , Spain
Guangzhou, , China
Seoul, , Korea, Republic Of
Tartu, , Estonia
Feldkirch, , Austria
Miami, Florida, United States
Camperdown, , Australia
Ankara, , Turkey
Osaka, , Japan
Fukuoka, , Japan
Kobe, , Japan
Tokyo, , Japan
Tokyo, , Japan
Sevilla, , Spain
Bristol, , United Kingdom
Kyoto, , Japan
Vilnius, , Lithuania
Murdoch, Western Australia, Australia
Seoul, , Korea, Republic Of
Osaka, , Japan
Madrid, , Spain
Seongnam Si, , Korea, Republic Of
Anyang, , Korea, Republic Of
Pecs, , Hungary
Seoul, , Korea, Republic Of
Daejeon, , Korea, Republic Of
Cheonan, , Korea, Republic Of
Nanchang, , China
Kanazawa, , Japan
Bendigo, , Australia
Yantai, , China
Jinan, , China
Tupelo, Mississippi, United States
Chongqing, , China
Sao Paulo, , Brazil
Baton Rouge, Louisiana, United States
Heidelberg, , Australia
Newcastle, , Australia
Foshan, , China
Tianjin, , China
London, , United Kingdom
Shenyang, , China
Lauderdale Lakes, Florida, United States
Taipei, , Taiwan
Sheung Wan, , Hong Kong
San Francisco, California, United States
Fuzhou, , China
Albuquerque, New Mexico, United States
Ningbo, , China
Istanbul, , Turkey
Sapporo Shi, , Japan
Shijiazhuang, , China
Valmiera, , Latvia
New Taipei City, , Taiwan
Yinchuan, , China
Kitakyushu Shi, , Japan
Hangzhou, , China
Madrid, , Spain
Doral, Florida, United States
Murdoch, , Australia
Itabashi Ku, , Japan
Koshigaya, , Japan
Hefei, Anhui, China
Orlando, Florida, United States
Clayton, , Australia
Shanghai, , China
Guiyang, Guizhou, China
Taichung, , Taiwan
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
London, , United Kingdom
Beijing, , China
Changzhi, , China
Salt Lake City, Utah, United States
Guangzhou, , China
Hefei, , China
Lufkin, Texas, United States
Linz, , Austria
Arvada, Colorado, United States
Charlotte, North Carolina, United States
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Houston, Texas, United States
Taiyuan, , China
Nantes, , France
Dallas, Texas, United States
Cangzhou, , China
Le Puy En Velay, , France
Denver, Colorado, United States
Genova, , Italy
Birtinya, , Australia
Seoul, , Korea, Republic Of
Glasgow, , United Kingdom
Dresden, , Germany
Hohhot, , China
Kita Ku, , Japan
Linköping, , Sweden
Zerifin, , Israel
Lincoln, Nebraska, United States
Orangeburg, South Carolina, United States
Huddinge, , Sweden
Guangzhou, , China
Fukuoka, , Japan
Coral Springs, Florida, United States
El Paso, Texas, United States
Huntsville, Alabama, United States
Madrid, , Spain
Pamplona, , Spain
Yongin Si, , Korea, Republic Of
Miami, Florida, United States
Garran, , Australia
Ningbo, , China
Miami, Florida, United States
Pasadena, Texas, United States
Glasgow, , United Kingdom
Lewisville, Texas, United States
East Providence, Rhode Island, United States
Changchun, , China
Shenzhen, , China
Juiz De Fora, , Brazil
Chongqing, , China
Guangzhou, Guangdong, China
Pompano Beach, Florida, United States
Los Angeles, California, United States
Hollywood, Florida, United States
Lawrenceville, Georgia, United States
Chubbuck, Idaho, United States
Idaho Falls, Idaho, United States
Meridian, Idaho, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Albany, New York, United States
Katy, Texas, United States
Hollywood, Florida, United States
Melbourne, Florida, United States
Atlanta, Georgia, United States
Rockford, Illinois, United States
Edina, Minnesota, United States
Tokyo, , Japan
Metairie, Louisiana, United States
Shatin, , Hong Kong
Jinan, , China
Las Vegas, Nevada, United States
Manassas, Virginia, United States
Fremont, California, United States
Pembroke Pines, Florida, United States
Sweetwater, Florida, United States
Newnan, Georgia, United States
Naperville, Illinois, United States
Indianapolis, Indiana, United States
Hamilton, New Jersey, United States
Providence, Rhode Island, United States
Fairfax, Virginia, United States
Gosford, , Australia
Birmingham, , United Kingdom
Tallin, , Estonia
Orange, California, United States
Dallas, Texas, United States
Hamilton, , Canada
Louisville, Kentucky, United States
Newark, Delaware, United States
Miami, Florida, United States
Shelby, Michigan, United States
Knoxville, Tennessee, United States
Abilene, Texas, United States
Bellaire, Texas, United States
Ballarat, , Australia
Brisbane, , Australia
Reservoir, , Australia
Wels Grieskirchen, , Austria
Beijing, , China
Chengdu, , China
Dongguan, , China
Guilin, , China
Taian, , China
Wuxi, , China
Xuancheng, , China
Yichang, , China
Nový Jičín, , Czechia
Copenhagen, , Denmark
Bordeaux, , France
Creteil, , France
Marseille, , France
St Priest En Jarez, , France
Valenciennes, , France
Berlin, , Germany
Aichi, , Japan
Amagasaki, , Japan
Kahoku, , Japan
Kashihara, , Japan
Kasugai, , Japan
Kyoto Shi, , Japan
Miyazaki, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tomigusuku, , Japan
Toyama Shi, , Japan
Urayasu Shi, , Japan
Cheonan, , Korea, Republic Of
Gangwon Do, , Korea, Republic Of
Gangwon Do, , Korea, Republic Of
Goyang Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Riga, , Latvia
Kaunas, , Lithuania
Oslo, , Norway
Krakow, , Poland
Warszawa, , Poland
Danderyd, , Sweden
Kocaeli, , Turkey
Newcastle Upon Tyne, , United Kingdom
Stockton On Tees, , United Kingdom
Wirral (Liverpool), , United Kingdom
Houston, Texas, United States
Fuyang City, , China
Pavia, , Italy
Lleida, , Spain
Mishawaka, Indiana, United States
Jersey City, New Jersey, United States
Nantong City, , China
Yangzhou City, , China
Sendai Shi, , Japan
Tokyo, , Japan
Yancheng City, , China
Lin Yi City, , China
Zamosc, , Poland
Melbourne, , Australia
Belo Horizonte, , Brazil
Shaanxi, , China
Veracruz, , Mexico
Nove Mesto, , Czechia
Petah Tivka, , Israel
Taipei, , Taiwan
Zagreb, , Croatia
Kolding, , Denmark
Aachen, , Germany
Fresno, California, United States
Belo Horizonte, , Brazil
Brasilia, , Brazil
Rio De Janeiro, , Brazil
Sao Paolo, , Brazil
Luoyang, , China
Hillerod, , Denmark
Barcelona, , Spain
Cambridge, , United Kingdom
Goiania, , Brazil
Recife, , Brazil
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported