Ziltivekimab
DrugParticipants will be administered 3 doses subcutaneously (s.c.) every four weeks (Q4W).
NCT Number: NCT05379829
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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Notify Me18 year and older
All sexes
Interventional
Phase 1
Beijing Hospital, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laboratory values
Medical conditions
Participants will be administered 3 doses subcutaneously (s.c.) every four weeks (Q4W).
Participants will be administered 3 doses s.c. Q4W.
Time frame: During 3rd dosing interval (week 8 to week 12)
Nanograms per millilitre*days (ng/mL*days)
Time frame: From baseline (week 0) to end of treatment (week 12)
Milligrams per millilitre (mg/L)
Time frame: During 1st dosing interval (day 0 to week 4)
ng/mL*days
Time frame: After last dose (week 8) to end of study (week 20)
ng/mL
Time frame: After last dose (week 8) to end of study (week 20)
Days
Novo Nordisk A/S
Industry
Pharmacokinetics, Pharmacodynamics and Safety of Ziltivekimab Versus Placebo in Chinese Participants With Chronic Kidney Disease and Systemic Inflammation
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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