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COMPLETED
NCT04626505
PHASE2

Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition in Japan.

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

The purpose of this research study is to compare the safety and effectiveness of 2 different doses of a study drug called ziltivekimab to placebo (an inactive substance) in reducing inflammation and improving some of the bad effects of inflammation on heart disease. Participants will be randomly (by chance) assigned to receive either ziltivekimab or placebo. The chance that participants will be assigned into one of the three study arms of ziltivekimab (either 15 mg or 30 mg) or placebo is the same (approximately 33%). This is a double-blind study, which means neither participants nor the study doctor will know which group the participants are in. In case of an emergency, however, the study doctor can get this information. The study drug will be injected under the skin once every 4 weeks. In this study participants will receive 3 injections of study drug. The total study duration for each participant will be approximately 6 months.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody-Mediated Interleukin-6 Inhibition in Japan

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2020-10-22

Completion Date

2021-09-28

Last Updated

2026-05-06

Healthy Volunteers

No

Interventions

DRUG

Ziltivekimab

Administered subcutaneously (s.c., under skin) once every 4 weeks for 12 weeks

DRUG

Placebo (ziltivekimab)

Administered s.c. once every 4 weeks for 12 weeks

Locations (1)

Ehime Medical Center

Ehime, Japan