| Trial ID: | L0700 |
| Source ID: | NCT04626505
|
| Associated Drug: |
Ziltivekimab
|
| Title: |
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition in Japan.
|
| Acronym: |
RESCUE-2
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Inflammation|Cardiovascular Risk
|
| Interventions: |
DRUG: Ziltivekimab|DRUG: Placebo (ziltivekimab)
|
| Outcome Measures: |
Primary: The difference in the percent change in high-sensitivity C-reactive protein (hs-CRP) levels (average of all hs-CRP values prior to the administration of study drug) between each active group and placebo, Percent change, From baseline (week 0) to the end of treatment (week 12) | Secondary: Number of adverse events (AEs), Count of events, From randomisation (week 0) to week 20|Number of serious adverse events (SAEs), Count of events, From randomisation (week 0) to week 20|Participants with AEs leading to discontinuation, Count of participant, From randomisation (week 0) to week 20
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S | Collaborators: Sponsor: Corvidia Therapeutics Inc, a subsidiary of Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-10-22
|
| Completion Date: |
2021-09-28
|
| Results First Posted: |
|
| Last Update Posted: |
2021-10-27
|
| Locations: |
Novo Nordisk Investigational Site, Ehime, 791-0281, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT04626505
|
