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NCT Number: NCT05379829

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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 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).
  • 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).
  • 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).

Treatment and study plan

Ziltivekimab

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, multiple doses [MD] (AUCτ,MD)

    Time frame: During 3rd dosing interval (week 8 to week 12)

    Nanograms per millilitre*days (ng/mL*days)

Secondary outcomes

  1. Change in hs-CRP (high-sensitivity C-reactive protein

    Time frame: From baseline (week 0) to end of treatment (week 12)

    Milligrams per millilitre (mg/L)

  2. Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, single dose [SD]

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

    ng/mL*days

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

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

    ng/mL

  4. Elimination half-life (t½)

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

    Days

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Pharmacokinetics, Pharmacodynamics and Safety of Ziltivekimab Versus Placebo in Chinese Participants With Chronic Kidney Disease and Systemic Inflammation

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 18, 2022
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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