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

NCT05379829 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 2834) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-30
Primary Completion
2024-06-12
Completion
2024-09-02
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05379829 on ClinicalTrials.gov