NCT05379829CompletedPhase 1
A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation
Pharmacokinetics, Pharmacodynamics and Safety of Ziltivekimab Versus Placebo in Chinese Participants With Chronic Kidney Disease and Systemic Inflammation
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
This study is conducted to see how the ziltivekimab works in the body of Chinese people with chronic kidney disease and systemic inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body. Participants' chance of getting ziltivekimab or placebo is the same. 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 15 May 2022
- Start date
- 30 May 2022
- Primary completion date
- 12 Jun 2024
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Chronic kidney disease
- NCT number
- NCT05379829
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 24
- From 30 May 2022 to the primary completion date, 12 Jun 2024
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of gastrointestinal perforation. (Note: History of perforated appendicitis more than 5 years prior to screening (visit 1) is not exclusionary).
- History of active diverticulitis in the 5 years prior to randomization (visit 2).
- History of inflammatory bowel disease that has been clinically active during the 12 months prior to randomization (visit 2).
- Myocardial infarction, stroke, hospitalization for unstable angina pectoris, or transient ischemic attack within 60 days prior to randomization (visit 2).
- 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).
Other illness
- Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
Lab values
- Laboratory values
- Absolute neutrophil count less than 2×10\^9/Litre at screening (visit 1).
- Platelet count less than 120×10\^9/Litre at screening (visit 1).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 × upper limit of normal at screening (visit 1).
- Medical conditions
Other
- Planned coronary, carotid or peripheral artery revascularization known on the day of screening (visit 1).
Who the study is looking for
- 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)
- Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 mg/L \[Milligram Per Litre\] at screening (visit 1).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Chinses People's Liberation Army General Hospital-Nephrology Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Zhongda Hospital Southeast University-Nephrology Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Zhongda Hospital Southeast University-Neurology Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| The First Affiliated Hospital of Soochow University-Endocrinology Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.