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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1266-5585 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ziltivekimab 15 mg | Experimental | Participants will receive ziltivekimab at weeks 0, 4 and 8. |
|
| Placebo | Placebo Comparator | Participants will receive placebo at weeks 0, 4 and 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziltivekimab | Drug | Participants will be administered 3 doses subcutaneously (s.c.) every four weeks (Q4W). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, multiple doses [MD] (AUCÏ„,MD) | Nanograms per millilitre*days (ng/mL*days) | During 3rd dosing interval (week 8 to week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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] |
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Inclusion criteria:
Exclusion criteria:
Laboratory values
Medical conditions
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).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China | ||
| Beijing Hospital |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo | Drug | Participants will be administered 3 doses s.c. Q4W. |
|
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) |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| Chinses People's Liberation Army General Hospital-Nephrology | Beijing | Beijing Municipality | 100853 | 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 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000718191 | ziltivekimab |
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