New drug ziltivekimab tested for kidney disease inflammation
NCT ID NCT05379829
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial studied how ziltivekimab works in the body of 24 Chinese adults with chronic kidney disease and signs of inflammation. Participants received either the drug or a placebo as three injections over several weeks. The study measured drug levels and safety, with results expected to guide future research.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ziltivekimab
- What this could lead to
- If successful, this could point toward a treatment that reduces inflammation in people with chronic kidney disease.
- What could go wrong
- This is a very early Phase 1 trial with only 24 participants, so results may not apply to larger populations. The drug may not show meaningful benefits or could have side effects.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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24 people
The number who actually took part.
- Started
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May 2022
- Finished
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Sep 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: 1. Estimated glomerular filtration rate (eGFR) greater than or equal 15 and less than 60 mL/min/1.73 m\^2 \[Millilitre/minute\] (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation) 2. Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 mg/L \[Milligram Per Litre\] at screening (visit 1). Exclusion criteria: Laboratory values 1. Absolute neutrophil count less than 2×10\^9/Litre at screening (visit 1). 2. Platelet count less than 120×10\^9/Litre at screening (visit 1). 3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 × upper limit of normal at screening (visit 1). Medical conditions 1. Clinical evidence of, or suspicion of, active infection at the discretion of the investigator. 2. History of gastrointestinal perforation. (Note: History of perforated appendicitis more than 5 years prior to screening (visit 1) is not exclusionary). 3. History of active diverticulitis in the 5 years prior to randomization (visit 2). 4. History of inflammatory bowel disease that has been clinically active during the 12 months prior to randomization (visit 2). 5. Myocardial infarction, stroke, hospitalization for unstable angina pectoris, or transient ischemic attack within 60 days prior to randomization (visit 2). 6. Planned coronary, carotid or peripheral artery revascularization known on the day of screening (visit 1). 7. Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomization (visit 2) or any major surgical procedure planned at the time of randomization (visit 2). Prior or current medication 1\. Use of preventive systemic antibiotics, systemic antivirals, or systemic antifungals at screening (visit 1). (Note: "Systemic" is defined as oral or intravenous (i.v.) administered drugs that are absorbed into the circulation). 2\. Use of systemic immunosuppressive drugs (both small molecules and biologics) or biologic disease modifying anti-rheumatic drugs (DMARDs including both biologic DMARDs like anti-TNF-alpha and conventional DMARDs like methotrexate) at screening (visit 1) or anticipated chronic use of such drugs any time during the study. (Note: Use of otic, ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections are not exclusionary).
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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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Beijing Hospital
Beijing, Beijing Municipality, 100730, China
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Chinses People's Liberation Army General Hospital-Nephrology
Beijing, Beijing Municipality, 100853, China
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Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
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The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, 215006, China
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The First Affiliated Hospital of Soochow University-Endocrinology
Suzhou, Jiangsu, 215006, China
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Zhongda Hospital Southeast University-Nephrology
Nanjing, Jiangsu, 210009, China
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Zhongda Hospital Southeast University-Neurology
Nanjing, Jiangsu, 210009, China