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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

May 30, 2022

Status verified

Dec 2025

Primary completion

Jun 12, 2024

Completion

Sep 2, 2024

Study Design

Enrollment

24 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ziltivekimab 15 mg
  Participants will receive ziltivekimab at weeks 0, 4 and 8.
• Placebo Comparator: Placebo
  Participants will receive placebo at weeks 0, 4 and 8.

Primary Outcome Measure

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) ]