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A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation

Primary Purpose

Chronic Kidney Disease and Systemic Inflammation

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Ziltivekimab
Placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease and Systemic Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Estimated glomerular filtration rate (eGFR) greater than or equal 15 and less than 60 mL/min/1.73 m^2 [Millilitre/minute] (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)
  2. Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 mg/L [Milligram Per Litre] at screening (visit 1).

Exclusion criteria:

Laboratory values

  1. Absolute neutrophil count less than 2×10^9/Litre at screening (visit 1).
  2. Platelet count less than 120×10^9/Litre at screening (visit 1).
  3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 × upper limit of normal at screening (visit 1).

Medical conditions

  1. Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
  2. History of gastrointestinal perforation. (Note: History of perforated appendicitis more than 5 years prior to screening (visit 1) is not exclusionary).
  3. History of active diverticulitis in the 5 years prior to randomization (visit 2).
  4. History of inflammatory bowel disease that has been clinically active during the 12 months prior to randomization (visit 2).
  5. Myocardial infarction, stroke, hospitalization for unstable angina pectoris, or transient ischemic attack within 60 days prior to randomization (visit 2).
  6. Planned coronary, carotid or peripheral artery revascularization known on the day of screening (visit 1).
  7. Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomization (visit 2) or any major surgical procedure planned at the time of randomization (visit 2). Prior or current medication

1. Use of preventive systemic antibiotics, systemic antivirals, or systemic antifungals at screening (visit 1). (Note: "Systemic" is defined as oral or intravenous (i.v.) administered drugs that are absorbed into the circulation).

2. Use of systemic immunosuppressive drugs (both small molecules and biologics) or biologic disease modifying anti-rheumatic drugs (DMARDs including both biologic DMARDs like anti-TNF-alpha and conventional DMARDs like methotrexate) at screening (visit 1) or anticipated chronic use of such drugs any time during the study. (Note: Use of otic, ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections are not exclusionary).

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ziltivekimab 15 mg

Placebo

Arm Description

Participants will receive ziltivekimab at weeks 0, 4 and 8.

Participants will receive placebo at weeks 0, 4 and 8.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in hs-CRP (high-sensitivity C-reactive protein
Milligrams per millilitre (mg/L)
Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, single dose [SD]
ng/mL*days
Maximum plasma concentration of ziltivekimab after 3rd dose (Cmax,MD)
ng/mL
Elimination half-life (t½)
Days

Full Information

First Posted
May 15, 2022
Last Updated
June 9, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05379829
Brief Title
A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation
Official Title
Pharmacokinetics, Pharmacodynamics and Safety of Ziltivekimab Versus Placebo in Chinese Participants With Chronic Kidney Disease and Systemic Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
July 27, 2023 (Anticipated)
Study Completion Date
May 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is conducted to see how the ziltivekimab works in the body of Chinese people with chronic kidney disease and systemic inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body. Participants' chance of getting ziltivekimab or placebo is the same. Participants will get their study medicine in a pre-filled syringe. The study doctor or staff will do 3 injections of study medicine during clinical visits. The study is expected to last for about 6 months. Participants will have blood and urine samples taken at all of the clinic visits. Participants will have their heart examined using electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease and Systemic Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ziltivekimab 15 mg
Arm Type
Experimental
Arm Description
Participants will receive ziltivekimab at weeks 0, 4 and 8.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo at weeks 0, 4 and 8.
Intervention Type
Drug
Intervention Name(s)
Ziltivekimab
Intervention Description
Participants will be administered 3 doses subcutaneously (s.c.) every four weeks (Q4W).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will be administered 3 doses s.c. Q4W.
Primary Outcome Measure Information:
Title
Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, multiple doses [MD] (AUCτ,MD)
Description
Nanograms per millilitre*days (ng/mL*days)
Time Frame
During 3rd dosing interval (week 8 to week 12)
Secondary Outcome Measure Information:
Title
Change in hs-CRP (high-sensitivity C-reactive protein
Description
Milligrams per millilitre (mg/L)
Time Frame
From baseline (week 0) to end of treatment (week 12)
Title
Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, single dose [SD]
Description
ng/mL*days
Time Frame
During 1st dosing interval (day 0 to week 4)
Title
Maximum plasma concentration of ziltivekimab after 3rd dose (Cmax,MD)
Description
ng/mL
Time Frame
After last dose (week 8) to end of study (week 20)
Title
Elimination half-life (t½)
Description
Days
Time Frame
After last dose (week 8) to end of study (week 20)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Estimated glomerular filtration rate (eGFR) greater than or equal 15 and less than 60 mL/min/1.73 m^2 [Millilitre/minute] (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation) Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 mg/L [Milligram Per Litre] at screening (visit 1). Exclusion criteria: Laboratory values Absolute neutrophil count less than 2×10^9/Litre at screening (visit 1). Platelet count less than 120×10^9/Litre at screening (visit 1). Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 × upper limit of normal at screening (visit 1). Medical conditions Clinical evidence of, or suspicion of, active infection at the discretion of the investigator. History of gastrointestinal perforation. (Note: History of perforated appendicitis more than 5 years prior to screening (visit 1) is not exclusionary). History of active diverticulitis in the 5 years prior to randomization (visit 2). History of inflammatory bowel disease that has been clinically active during the 12 months prior to randomization (visit 2). Myocardial infarction, stroke, hospitalization for unstable angina pectoris, or transient ischemic attack within 60 days prior to randomization (visit 2). Planned coronary, carotid or peripheral artery revascularization known on the day of screening (visit 1). Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomization (visit 2) or any major surgical procedure planned at the time of randomization (visit 2). Prior or current medication 1. Use of preventive systemic antibiotics, systemic antivirals, or systemic antifungals at screening (visit 1). (Note: "Systemic" is defined as oral or intravenous (i.v.) administered drugs that are absorbed into the circulation). 2. Use of systemic immunosuppressive drugs (both small molecules and biologics) or biologic disease modifying anti-rheumatic drugs (DMARDs including both biologic DMARDs like anti-TNF-alpha and conventional DMARDs like methotrexate) at screening (visit 1) or anticipated chronic use of such drugs any time during the study. (Note: Use of otic, ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections are not exclusionary).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation

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