| Trial ID: | L0875 |
| Source ID: | NCT05379829
|
| Associated Drug: |
Ziltivekimab
|
| Title: |
A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease and Systemic Inflammation
|
| Interventions: |
DRUG: Ziltivekimab|DRUG: Placebo
|
| Outcome Measures: |
Primary: Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, multiple doses [MD] (AUCτ,MD), Nanograms per millilitre\*days (ng/mL\*days), During 3rd dosing interval (week 8 to week 12) | Secondary: Change in hs-CRP (high-sensitivity C-reactive protein, Milligrams per millilitre (mg/L), From baseline (week 0) to end of treatment (week 12)|Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, single dose [SD], ng/mL\*days, During 1st dosing interval (day 0 to week 4)|Maximum plasma concentration of ziltivekimab after 3rd dose (Cmax,MD), ng/mL, After last dose (week 8) to end of study (week 20)|Elimination half-life (t½), Days, After last dose (week 8) to end of study (week 20)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-05-30
|
| Completion Date: |
2024-09-02
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-04
|
| Locations: |
Peking University Third Hospital, Beijing, Beijing, 100191, China|Beijing Hospital, Beijing, Beijing, 100730, China|Zhongda Hospital Southeast University-Nephrology, Nanjing, Jiangsu, 210009, China|Zhongda Hospital Southeast University-Neurology, Nanjing, Jiangsu, 210009, China|The First Affiliated Hospital of Soochow University-Endocrinology, Suzhou, Jiangsu, 215006, China|The First Affiliated Hospital Of Soochow University, Suzhou, Jiangsu, 215006, China
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| URL: |
https://clinicaltrials.gov/show/NCT05379829
|
