NCT05379829

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Ziltivekimab	Participants will be administered 3 doses subcutaneously (s.c.) every four weeks (Q4W).
DRUG	Placebo	Participants will be administered 3 doses s.c. Q4W.

Timeline

• Start date: 2022-05-30
• Primary completion: 2024-06-12
• Completion: 2024-09-02
• First posted: 2022-05-18
• Last updated: 2025-12-31

Locations

7 sites across 1 country: China

Regulatory

• FDA-regulated drug study