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
Study ID
NCT04626505
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ziltivekimab — DRUG
    Administered subcutaneously (s.c., under skin) once every 4 weeks for 12 weeks
  • Placebo (ziltivekimab) — DRUG
    Administered s.c. once every 4 weeks for 12 weeks

Study Details

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.

Key Dates

Start date
Oct 22, 2020
Status verified
May 2026
Primary completion
Aug 3, 2021
Completion
Sep 28, 2021

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ziltivekimab 15 mg
    Participants will receive ziltivekimab 15 mg for 12 weeks.
  • Experimental: Ziltivekimab 30 mg
    Participants will receive ziltivekimab 30 mg for 12 weeks.
  • Placebo Comparator: Placebo (ziltivekimab)
    Participants will receive placebo (ziltivekimab) for 12 weeks.

Primary Outcome Measure

Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) Levels From Baseline (Average of All Hs-CRP Values Prior to the Administration of Study Drug) to the End of Treatment (Average of Week 10 and Week 12) [ Time Frame: Baseline (day 1), end of treatment (average of week 10 and week 12) ]

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