A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation
NCT ID: NCT05379829
Last Updated: 2025-12-31
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
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2022-05-30
2024-09-02
Brief Summary
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Participants will get their study medicine in a pre-filled syringe. The study doctor or staff will do 3 injections of study medicine during clinical visits.
The study is expected to last for about 6 months. Participants will have blood and urine samples taken at all of the clinic visits. Participants will have their heart examined using electrodes (electrocardiogram).
Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ziltivekimab 15 mg
Participants will receive ziltivekimab at weeks 0, 4 and 8.
Ziltivekimab
Participants will be administered 3 doses subcutaneously (s.c.) every four weeks (Q4W).
Placebo
Participants will receive placebo at weeks 0, 4 and 8.
Placebo
Participants will be administered 3 doses s.c. Q4W.
Interventions
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Ziltivekimab
Participants will be administered 3 doses subcutaneously (s.c.) every four weeks (Q4W).
Placebo
Participants will be administered 3 doses s.c. Q4W.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Chinses People's Liberation Army General Hospital-Nephrology
Beijing, Beijing Municipality, China
Zhongda Hospital Southeast University-Nephrology
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University-Neurology
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University-Endocrinology
Suzhou, Jiangsu, China
The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, China
Countries
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Other Identifiers
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U1111-1266-5585
Identifier Type: OTHER
Identifier Source: secondary_id
NN6018-4889
Identifier Type: -
Identifier Source: org_study_id