Could an antibody tame inflammation in kidney patients?
NCT ID NCT03926117
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a drug called ziltivekimab in 264 people with advanced chronic kidney disease and high inflammation. Participants received monthly injections of either a placebo or one of three doses of ziltivekimab for six months. The goal was to see if the drug could safely lower inflammation markers, which might reduce the risk of heart problems in these patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ziltivekimab (an antibody that blocks IL-6, a protein involved in inflammation)
- What this could lead to
- If successful, this could lead to a new treatment to lower inflammation and potentially reduce heart problems in people with advanced kidney disease.
- What could go wrong
- This is an early-phase trial with only 264 participants, so results may not apply to everyone. The drug may not work as hoped or could cause side effects like infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
264 people
The number who actually took part.
- Started
-
Jun 2019
- Finished
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Jun 2020
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 18 years of age * Stage 3-5 CKD * hs-CRP \> 2.0 mg/L * Comply with contraception Exclusion Criteria: * Low neutrophil count * Low platelet count * Spot urine protein to creatinine ration \> 4000 mg/g * ALT/AST \>2.5x ULN * TSAT \< 10% * Positive TB test * Evidence of HIV, hepatitis B * Blind or illiterate * Expected to require blood transfusion * Thromboembolic event within 12-weeks * Evidence of active infection * Peptic ulcer disease, diverticulitis, inflammatory bowel disease * Uncontrolled hypertension * Planned coronary revascularization * Major cardiac surgery, CHF * Active malignancy, bone marrow or organ transplant * Allergy to study drug * Treatment with investigational drug, treatment with HIF stabilizer or ESA * Use of immunosuppressive drugs, systemic antibiotics * Breastfeeding, any other significant medical history
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AMPM Research Clinic
Miami, Florida, 33169, United States
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Apex Research of Riverside
Riverside, California, 92505, United States
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Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, 85016, United States
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Aventiv Research
Mesa, Arizona, 85210, United States
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Biopharma Informatick Inc. Research Center
Houston, Texas, 77043, United States
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Capital Nephrology
Greenbelt, Maryland, 20770, United States
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Central Alabama Research
Birmingham, Alabama, 35205, United States
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Clinical Advancement Center, PLLC
San Antonio, Texas, 78212, United States
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Clinical Investigation Specialist, Inc
Kenosha, Wisconsin, 53142, United States
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Clinical Trials of America, LLC - West Monroe
Monroe, Louisiana, 71201, United States
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Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
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DaVita Clinical Research
Minneapolis, Minnesota, 55404, United States
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DaVita Clinical Research
The Bronx, New York, 10461, United States
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Elite Clinical Studies
Phoenix, Arizona, 85018, United States
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Florida Premier Research Institue, LLC
Winter Park, Florida, 32789, United States
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Henry Ford Health System
Detroit, Michigan, 48202, United States
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Investigator Research by Design, LLC
Chicago, Illinois, 60643, United States
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Julia and Israel Waldbaum Dialysis Center
Great Neck, New York, 11021, United States
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Juno Research, LLC - Northwest
Houston, Texas, 77070, United States
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Knoxville Kidney Center, PLLC
Knoxville, Tennessee, 37923, United States
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Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
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Metrolina Nephrology Associates
Charlotte, North Carolina, 28277, United States
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Metrolina Nephrology Associates, PA
Charlotte, North Carolina, 28207, United States
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Mountain Kidney and Hypertension Associates
Asheville, North Carolina, 28801, United States
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Mountain View CLinical Research - Greer
Greer, South Carolina, 29651, United States
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Nephrology Associates, PC
Nashville, Tennessee, 37205, United States
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Nephrology Research of Michigan
Saint Clair Shores, Michigan, 48081, United States
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North America Research Institute
Lynwood, California, 90262, United States
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North America Research Institute
Riverside, California, 92503, United States
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North America Research Institute
San Dimas, California, 91773, United States
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North Hills Medical Research, Inc
North Richland Hills, Texas, 76180, United States
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Northeast Clinical Research Center
Allentown, Pennsylvania, 18104, United States
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Northport VAMC
Northport, New York, 11768, United States
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Ocala Cardiovascular Research
Ocala, Florida, 34474, United States
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Onyx Clinical Research
Caro, Michigan, 48723, United States
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Piedmont Research Partners, LLC
Fort Mill, South Carolina, 29707, United States
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Renal Disease Research Institute
Dallas, Texas, 75246, United States
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Rhode Island Hospital
Providence, Rhode Island, 02903, United States
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San Antonio Kidney Disease Center Physicians Group, PLLC
San Antonio, Texas, 78229, United States
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Southeastern Clinical Research Institute, LLC
Augusta, Georgia, 30901, United States
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Southeastern Nephrology - Whiteville
Whiteville, North Carolina, 28472, United States
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Southeastern Nephrology Associates - Wilmington
Wilmington, North Carolina, 28401, United States
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Southside Urology and Nephrology
Danville, Virginia, 25241, United States
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St. Clair Nephrology Research
Roseville, Michigan, 48066, United States
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Summit Research Group, LLC
Stow, Ohio, 44224, United States
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University of Iowa
Iowa City, Iowa, 52242, United States
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University of Vermont
Burlington, Vermont, 05401, United States
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Vilo Research Group, Inc
Houston, Texas, 77017, United States
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Western Nephrology and Metabolic Bone Disease, PC
Arvada, Colorado, 80002, United States
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