A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation
- Conditions
- Chronic Kidney Disease and Systemic Inflammation
- Interventions
- Drug: Placebo
- Registration Number
- NCT05379829
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo at weeks 0, 4 and 8. Ziltivekimab 15 mg Ziltivekimab Participants will receive ziltivekimab at weeks 0, 4 and 8.
- Primary Outcome Measures
Name Time Method Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, multiple doses [MD] (AUCτ,MD) During 3rd dosing interval (week 8 to week 12) Nanograms per millilitre\*days (ng/mL\*days)
- Secondary Outcome Measures
Name Time Method Maximum plasma concentration of ziltivekimab after 3rd dose (Cmax,MD) After last dose (week 8) to end of study (week 20) ng/mL
Change in hs-CRP (high-sensitivity C-reactive protein From baseline (week 0) to end of treatment (week 12) Milligrams per millilitre (mg/L)
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) ng/mL\*days
Elimination half-life (t½) After last dose (week 8) to end of study (week 20) Days
Trial Locations
- Locations (6)
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Zhongda Hospital Southeast University-Nephrology
🇨🇳Nanjing, Jiangsu, China
Zhongda Hospital Southeast University-Neurology
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University-Endocrinology
🇨🇳Suzhou, Jiangsu, China
The First Affiliated Hospital Of Soochow University
🇨🇳Suzhou, Jiangsu, China