Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
Launched by CSL BEHRING · Aug 1, 2022
Trial Information
Current as of May 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called CSL300 (Clazakizumab) to see if it can help improve heart health for adults with end-stage kidney disease (ESKD) who are undergoing dialysis. The trial is divided into two parts: the first part will help determine the best dose of CSL300, and the second part will look at how well it works in preventing heart problems and keeping patients safe. Participants in this study must be at least 18 years old, have been on dialysis for at least 12 weeks, and have certain health conditions like diabetes or heart disease.
If you join this trial, you will be randomly assigned to receive either the study medication or a placebo (a harmless version that looks like the real medication but has no active ingredients). Throughout the study, your health will be closely monitored to check for any side effects and to see how well the medication is working. It's important to know that if you have certain medical conditions or have taken specific medications recently, you may not be eligible to participate. This trial is currently recruiting participants, so if you think you might qualify, it could be a great opportunity to contribute to research that aims to improve treatment options for people with ESKD and heart disease.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male or female at least 18 years of age
- • A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks
- • Serum hs-CRP ≥ 2.0 mg/L
- • A diagnosis of diabetes mellitus OR ASCVD
- Exclusion Criteria:
- • Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3)
- • Concomitant use of systemic immunosuppressant drugs
- • Abnormal LFTs
- • Any life-threatening disease expected to result in death within 12 months
- • A history of GI perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease
- • Clinically significant active infection or history of opportunistic or invasive fungal infection
About Csl Behring
CSL Behring is a global biotechnology leader focused on developing innovative therapies for patients with serious and rare diseases. As a subsidiary of CSL Limited, the company specializes in the research, development, and manufacture of life-saving biotherapies derived from human plasma. With a strong commitment to scientific excellence and patient care, CSL Behring conducts rigorous clinical trials to advance its portfolio of immunoglobulins, clotting factors, and other biopharmaceuticals. The organization aims to enhance the quality of life for patients worldwide while maintaining the highest standards of safety and efficacy in its products.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hampton, Virginia, United States
Huntsville, Alabama, United States
Bakersfield, California, United States
Bakersfield, California, United States
Los Angeles, California, United States
Lynwood, California, United States
San Diego, California, United States
Victorville, California, United States
Lauderdale Lakes, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Columbus, Georgia, United States
Roseville, Michigan, United States
Minneapolis, Minnesota, United States
Tupelo, Mississippi, United States
Kansas City, Missouri, United States
Portsmouth, New Hampshire, United States
Bronx, New York, United States
Durham, North Carolina, United States
Knoxville, Tennessee, United States
Hampton, Virginia, United States
Glendale, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Beverly Hills, California, United States
Chula Vista, California, United States
Glendale, California, United States
La Mesa, California, United States
La Palma, California, United States
Northridge, California, United States
San Diego, California, United States
San Jose, California, United States
Vacaville, California, United States
Denver, Colorado, United States
Bloomfield, Connecticut, United States
Middlebury, Connecticut, United States
Coral Gables, Florida, United States
Statesboro, Georgia, United States
Saint Clair Shores, Michigan, United States
Brookhaven, Mississippi, United States
North Platte, Nebraska, United States
College Point, New York, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Bethlehem, Pennsylvania, United States
Columbia, South Carolina, United States
Spartanburg, South Carolina, United States
Norfolk, Virginia, United States
Sydney, New South Wales, Australia
Nambour, Queensland, Australia
Woolloongabba, Queensland, Australia
Clayton, Victoria, Australia
St Albans, Victoria, Australia
Aalst, , Belgium
Bonheiden, , Belgium
Gent, , Belgium
Leuven, , Belgium
Liège, , Belgium
Edmonton, Alberta, Canada
Kiel, , Germany
Villingen Schwenningen, , Germany
Montgomery, Alabama, United States
Garden Grove, California, United States
Riverside, California, United States
San Dimas, California, United States
Victorville, California, United States
Las Vegas, Nevada, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Shenandoah, Texas, United States
Granada Hills, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Dimas, California, United States
Coral Springs, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Winter Park, Florida, United States
Brunswick, Georgia, United States
Sioux City, Iowa, United States
Wichita, Kansas, United States
Pontiac, Michigan, United States
Minneapolis, Minnesota, United States
Lincoln, Nebraska, United States
Henderson, Nevada, United States
Austin, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
El Paso, Texas, United States
San Antonio, Texas, United States
Chesapeake, Virginia, United States
Glendale, Arizona, United States
La Mesa, California, United States
Oxnard, California, United States
Denver, Colorado, United States
Newark, Delaware, United States
Boca Raton, Florida, United States
Miami Lakes, Florida, United States
Temple Terrace, Florida, United States
Douglasville, Georgia, United States
Kalamazoo, Michigan, United States
Reno, Nevada, United States
Jersey City, New Jersey, United States
Raleigh, North Carolina, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Mcallen, Texas, United States
Fairfax, Virginia, United States
Bluefield, West Virginia, United States
Halifax, Nova Scotia, Canada
Kingston, Ontario, Canada
Kagoshima Shi, , Japan
Nagaoka Shi, , Japan
Oyama Shi, , Japan
Tsukuba Shi, , Japan
Ube Shi, , Japan
Yonago Shi, , Japan
Fullerton, California, United States
Fullerton, California, United States
Garden Grove, California, United States
Garden Grove, California, United States
Glendale, California, United States
La Palma, California, United States
Miami, Florida, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Columbus, Mississippi, United States
Columbus, Ohio, United States
Houston, Texas, United States
San Antonio, Texas, United States
Ioánnina, , Greece
Thessaloniki, , Greece
Thessaloníki, , Greece
Thessaloníki, , Greece
Caserta, , Italy
Foggia, , Italy
Ichinomiya Shi, Aichi, Japan
Maebashi Shi, Gunma, Japan
Maebashi Shi, Gunma, Japan
Sapporo Shi, Hokkaido, Japan
Kusatsu Shi, Shiga, Japan
Hashima Gun, , Japan
Higashiosaka Shi, , Japan
Inashiki Gun, , Japan
Kurume Shi, , Japan
Kyoto Shi, , Japan
Nagoya Shi, , Japan
Nagoya, , Japan
Omihachiman, , Japan
Sakaimachi, , Japan
Takasaki Shi, , Japan
Braga, , Portugal
Oeiras, , Portugal
Uppsala, , Sweden
Tarzana, California, United States
Bronx, New York, United States
Urayasu Shi, Chiba Ken, Japan
Riverside, California, United States
Mishawaka, Indiana, United States
Eatontown, New Jersey, United States
Houston, Texas, United States
Saint Leonards, New South Wales, Australia
Wollongong, , Australia
Herlev, , Denmark
Kaiserslautern, , Germany
Ioánnina, , Greece
Rio, , Greece
Thessaloníki, , Greece
árta, , Greece
Ramat Gan, , Israel
Florence, , Italy
Pavia, , Italy
Rimini, , Italy
Kitakyushu Shi, Fukuoka, Japan
Shinjuku Ku, Tokyo, Japan
Kurume, , Japan
Yokohama Shi, , Japan
Constanta, , Romania
Bradford, , United Kingdom
Hamilton, Ontario, Canada
Oshawa, Ontario, Canada
Montreal, Quebec, Canada
Aalborg, , Denmark
Hillerød, , Denmark
Mainz, , Germany
Larissa, , Greece
H̱olon, , Israel
Petah Tikva, , Israel
Tel Aviv, , Israel
Brescia, , Italy
Peschiera Del Garda, , Italy
San Giovanni Rotondo, , Italy
Verona, , Italy
Hokkaido, , Japan
Hialeah Gardens, Florida, United States
Medley, Florida, United States
Cairns, Queensland, Australia
Murdoch, , Australia
Stara Zagora, , Bulgaria
London, Ontario, Canada
Amiens, , France
Caen, , France
Paris, , France
Toulouse, , France
Berlin, , Germany
Hessen, , Germany
Kistarcsa, , Hungary
Haifa, , Israel
Zefat, , Israel
Messina, , Italy
Prato, , Italy
Ilsan Gu, Seoul, Korea, Republic Of
Goyang Si, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Bucuresti, , Romania
Satu Mare, , Romania
Londonderry, , United Kingdom
Stoke On Trent, , United Kingdom
Beaumont, Texas, United States
Lom, , Bulgaria
Toronto, , Canada
Strasbourg, , France
Heraklion, , Greece
Milano, , Italy
Seoul, , Korea, Republic Of
Bucharest, , Romania
Salinas, California, United States
Houston, Texas, United States
Southport, , Australia
Westmead, , Australia
Roeselare, , Belgium
Smolyan, , Bulgaria
Herning, , Denmark
Brest, , France
Saint Ouen, , France
Crete, , Greece
Thessaloníki, , Greece
Tiberias, , Israel
Anyang Si, , Korea, Republic Of
Daegu, , Korea, Republic Of
Gangnam Gu, , Korea, Republic Of
Wonju Si, , Korea, Republic Of
Porto, , Portugal
Coventry, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Tarzana, California, United States
Hollywood, Florida, United States
Miami, Florida, United States
Albany, Georgia, United States
Kansas City, Missouri, United States
Mineola, New York, United States
Knoxville, Tennessee, United States
Mansfield, Texas, United States
La Louvière, , Belgium
Montréal, Quebec, Canada
Montréal, , Canada
Montréal, , Canada
Beijing, , China
Zhenjiang City, , China
Aura, , France
Limoges Cedex, , France
Montpellier, , France
Alexandroupolis, , Greece
Lecco, , Italy
Novara, , Italy
Loures, , Portugal
Lleida, , Spain
Derby, , United Kingdom
Salford, , United Kingdom
Wolverhampton, , United Kingdom
Patients applied
Trial Officials
Study Director
Study Director
CSL Behring LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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