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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease and Systemic Inflammation
• Intervention / Treatment: Drug: Ziltivekimab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Hospital
    • Beijing, Beijing Municipality, China, 100853
      • Chinses People's Liberation Army General Hospital-Nephrology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University-Neurology
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University-Nephrology
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University-Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ziltivekimab 15 mg; Participants will receive ziltivekimab at weeks 0, 4 and 8.	Drug: Ziltivekimab; Participants will be administered 3 doses subcutaneously (s.c.) every four weeks (Q4W).
Placebo Comparator: Placebo; Participants will receive placebo at weeks 0, 4 and 8.	Drug: Placebo; Participants will be administered 3 doses s.c. Q4W.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, multiple doses [MD] (AUCτ,MD)	Nanograms per millilitre*days (ng/mL*days)	During 3rd dosing interval (week 8 to week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hs-CRP (high-sensitivity C-reactive protein	Milligrams per millilitre (mg/L)	From baseline (week 0) to end of treatment (week 12)
Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, single dose [SD]	ng/mL*days	During 1st dosing interval (day 0 to week 4)
Maximum plasma concentration of ziltivekimab after 3rd dose (Cmax,MD)	ng/mL	After last dose (week 8) to end of study (week 20)
Elimination half-life (t½)	Days	After last dose (week 8) to end of study (week 20)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): September 2, 2024

Study Registration Dates

• First Submitted: May 15, 2022
• First Submitted That Met QC Criteria: May 15, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; ziltivekimab
• Other Study ID Numbers: NN6018-4889; U1111-1266-5585 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes