A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation

NCT05379829 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN6018-4889U1111-1266-5585
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Chronic Kidney Disease and Systemic Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in hs-CRP (high-sensitivity C-reactive protein

  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]

  During 1st dosing interval (day 0 to week 4)

• Maximum plasma concentration of ziltivekimab after 3rd dose (Cmax,MD)

  After last dose (week 8) to end of study (week 20)

• Elimination half-life (t½)

  After last dose (week 8) to end of study (week 20)

Study Arms (2)

Ziltivekimab 15 mg

EXPERIMENTAL

Participants will receive ziltivekimab at weeks 0, 4 and 8.

Drug: Ziltivekimab

Placebo

PLACEBO COMPARATOR

Participants will receive placebo at weeks 0, 4 and 8.

Drug: Placebo

Interventions

Ziltivekimab DRUG

Participants will be administered 3 doses subcutaneously (s.c.) every four weeks (Q4W).

Ziltivekimab 15 mg

Placebo DRUG

Participants will be administered 3 doses s.c. Q4W.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
• 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).
• Planned coronary, carotid or peripheral artery revascularization known on the day of screening (visit 1).
• 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
• \. 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).

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (7)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Chinses People's Liberation Army General Hospital-Nephrology

Beijing, Beijing Municipality, 100853, China

Location

Zhongda Hospital Southeast University-Nephrology

Nanjing, Jiangsu, 210009, China

Location

Zhongda Hospital Southeast University-Neurology

Nanjing, Jiangsu, 210009, China

Location

The First Affiliated Hospital of Soochow University-Endocrinology

Suzhou, Jiangsu, 215006, China

Location

The First Affiliated Hospital Of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

ziltivekimab

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: May 18, 2022
• Study Start: May 30, 2022
• Primary Completion: June 12, 2024
• Study Completion: September 2, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (7)