NCT04626505

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease
• Inflammation
• Cardiovascular Risk

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-10-22
• Primary completion: 2021-08-03
• Completion: 2021-09-28
• First posted: 2020-11-12
• Last updated: 2021-10-27

Locations

1 site across 1 country: Japan