Chronic Kidney Disease and Systemic InflammationPhase 1NCT05379829
A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation
A Phase 1 study testing Ziltivekimab in people with Chronic Kidney Disease and Systemic Inflammation, run by Novo Nordisk A/S at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease and Systemic Inflammation
- What is being tested?
- Ziltivekimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 7 sitesChina
- Study dates
- 30 May 2022to 2 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 14Show fewer
- 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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Beijing Hospital
Beijing, Beijing Municipality, 100730
Chinses People's Liberation Army General Hospital-Nephrology
Beijing, Beijing Municipality, 100853
Zhongda Hospital Southeast University-Nephrology
Nanjing, Jiangsu, 210009
Zhongda Hospital Southeast University-Neurology
Nanjing, Jiangsu, 210009
The First Affiliated Hospital of Soochow University-Endocrinology
Suzhou, Jiangsu, 215006
The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: Pharmacokinetics, Pharmacodynamics and Safety of Ziltivekimab Versus Placebo in Chinese Participants With Chronic Kidney Disease and Systemic Inflammation
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.
Read more
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.
- Being tested
- Ziltivekimab, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiltivekimabDrug
Participants will be administered 3 doses subcutaneously (s.c.) every four weeks (Q4W).
PlaceboDrug
Participants will be administered 3 doses s.c. Q4W.
| Study group | Role | What they receive |
|---|---|---|
| Ziltivekimab 15 mg | Experimental | Participants will receive ziltivekimab at weeks 0, 4 and 8. Receives: Drug: Ziltivekimab |
| Placebo | Placebo comparator | Participants will receive placebo at weeks 0, 4 and 8. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During 3rd dosing interval (week 8 to week 12)
Secondary outcomes (4)
Change in hs-CRP (high-sensitivity C-reactive protein
Milligrams per millilitre (mg/L)
Measured: 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
Measured: During 1st dosing interval (day 0 to week 4)
Maximum plasma concentration of ziltivekimab after 3rd dose (Cmax,MD)
ng/mL
Measured: After last dose (week 8) to end of study (week 20)
Elimination half-life (t½)
Days
Measured: After last dose (week 8) to end of study (week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start30 May 2022
- Primary completion12 Jun 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease and Systemic InflammationStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379829
- Sponsor's protocol ID
- NN6018-4889
- Other IDs
- U1111-1266-5585
- Status last verified
- Dec 2025
- First submitted
- 15 May 2022
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Pharmacodynamics and Safety of Ziltivekimab Versus Placebo in Chinese Participants With Chronic Kidney Disease and Systemic Inflammation
- ClinicalTrials.gov ID
- NCT05379829
- Acronym / sponsor ID
- NN6018-4889
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 30 May 2022 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ziltivekimab 15 mg | Experimental | Drug: ZiltivekimabParticipants will receive ziltivekimab at weeks 0, 4 and 8. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo at weeks 0, 4 and 8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZiltivekimabParticipants will be administered 3 doses subcutaneously (s.c.) every four weeks (Q4W). | Drug | Ziltivekimab 15 mg |
| PlaceboParticipants will be administered 3 doses s.c. Q4W. | Drug | Placebo |
Primary outcome
Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, multiple doses [MD] (AUCτ,MD)
Time frame: During 3rd dosing interval (week 8 to week 12)
Nanograms per millilitre*days (ng/mL*days)
4 secondary outcomes
Change in hs-CRP (high-sensitivity C-reactive protein
Time frame: 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]
Time frame: During 1st dosing interval (day 0 to week 4)
Maximum plasma concentration of ziltivekimab after 3rd dose (Cmax,MD)
Time frame: After last dose (week 8) to end of study (week 20)
Elimination half-life (t½)
Time frame: After last dose (week 8) to end of study (week 20)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ziltivekimab in people with Chronic Kidney Disease and Systemic Inflammation, run by Novo Nordisk A/S at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, multiple doses [MD] (AUCτ,MD) (time frame: During 3rd dosing interval (week 8 to week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.