Trial · NCT03926117
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
NCT03926117, Phase 2, Completed, Novo Nordisk A/S; results first posted 2023-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition. Trials, record NCT03926117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03926117
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
- NCT number
- NCT03926117
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 264 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Chronic Kidney Diseases, Inflammation
- Interventions
- Ziltivekimab
- First posted
- 2019-04-24
- Last updated
- 2025-12-31
- Results first posted
- 2023-08-09
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels | Baseline (average of the hs-CRP value prior to randomization and day 1), week 13 | Percent change from baseline in hs-CRP levels at week 13 are presented. |
| Secondary | Percent Change From Baseline in Serum Amyloid A (SAA) | Baseline (average of the values at week -1 and day 1), week 13 | Percent change from baseline in SAA at week 13 are presented. |
| Secondary | Percent Change From Baseline in Fibrinogen | Baseline (day 1), week 13 | Percent change from baseline in fibrinogen at week 13 are presented. |
| Secondary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious AEs (TESAEs), Severe Hematologic AEs, Severe Non-hematologic AEs, and AEs Leading to Drug Discontinuation | From week 0 to week 32 | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAEs are defined as AEs that initiated or worsened on or after the date of first dose of study drug up to the end of safety-follow-up. A SAE was defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. TEAEs that met any of these criteria were considered severe hematologic AEs: grade 3 neutropenia, grade 3 anemia, grade 3 leukopenia, grade 3 lymphopenia, grade 3 eosinophilia, and grade 3 thrombocytopenia. |
| Secondary | Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Events | From week 0 to week 32 | Bleeding events were classified using the TIMI bleeding classification as follows: 1) major: intracranial hemorrhage or a \>=5 g/dL decrease in the hemoglobin concentration or a \>=15 percent (%) absolute decrease in the hematocrit; 2) minor: (a) observed blood loss: \>=3 g/dL decrease in the hemoglobin concentration or \>=10% decrease in the hematocrit. (b) no observed blood loss: \>=4 g/dL decrease in the hemoglobin concentration or \>=12% decrease in the hematocrit; 3) minimal: any clinically overt sign of hemorrhage (including imaging) that was associated with a \< 3 g/dL decrease in the hemoglobin concentration or \<9% decrease in the hematocrit. |
| Secondary | Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI) | From week 0 to week 32 | An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AESI included serious infections, malignancies, anaphylaxis occurring at any time, even if considered unrelated to the study drug, gastrointestinal perforations, hypersensitivity reaction during investigational product (IP) administration, neutrophils per cubic millimeter (500/mm\^3) (severe) or neutrophils \<1000/mm\^3 (severe) with evidence of concurrent infection, severe injection-related reactions, thrombocytopenia (platelet count \<50,000/mm\^3 (severe)) or platelet count \<75,000/mm\^3 (moderate) with evidence of concurrent TIMI major bleeding. |
| Secondary | Change in Systolic Blood Pressure (SBP) | Baseline (week 1), week 32 | Change from baseline in systolic blood pressure at week 32 are presented. |
| Secondary | Change in Diastolic Blood Pressure (DBP) | Baseline (week 1), week 32 | Change from baseline in diastolic blood pressure at week 32 are presented. |
| Secondary | Change in Respiratory Rate | Baseline (week 1), week 32 | Change from baseline in respiratory rate at week 32 are presented. |
| Secondary | Change in Body Mass Index (BMI) | Baseline (week 1), week 24 | Change from baseline in BMI at week 24 are presented. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels | Baseline (average of the hs-CRP value prior to randomization and day 1), week 13 | ITT analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data. | Percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Serum Amyloid A (SAA) | Baseline (average of the values at week -1 and day 1), week 13 | ITT analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data. | Percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Fibrinogen | Baseline (day 1), week 13 | ITT analysis population included all randomized participants. 'Overall Number of Participants Analyzed' = participants with available data. | Percent change | MEDIAN |
| SECONDARY | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious AEs (TESAEs), Severe Hematologic AEs, Severe Non-hematologic AEs, and AEs Leading to Drug Discontinuation | From week 0 to week 32 | The safety analysis population included all randomized participants who received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Events | From week 0 to week 32 | The safety analysis population included all randomized participants who received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI) | From week 0 to week 32 | The safety analysis population included all randomized participants who received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Change in Systolic Blood Pressure (SBP) | Baseline (week 1), week 32 | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change in Diastolic Blood Pressure (DBP) | Baseline (week 1), week 32 | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | mmHg | MEAN |
| SECONDARY | Change in Respiratory Rate | Baseline (week 1), week 32 | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | Breaths per minute (breaths/min) | MEAN |
| SECONDARY | Change in Body Mass Index (BMI) | Baseline (week 1), week 24 | The safety analysis population included all randomized participants who received at least 1 dose of study drug. 'Overall Number of Participants Analyzed' = participants with available data. | Kilograms per square meter (kg/m^2) | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group212
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels | Placebo | -4.49 | Inter-Quartile Range -35.54 to 46.27 | Percent change | |
| Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels | Ziltivekimab 7.5 mg | -76.57 | Inter-Quartile Range -86.89 to -57.14 | Percent change | |
| Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels | Ziltivekimab 15 mg | -88.12 | Inter-Quartile Range -92.11 to -78.95 | Percent change | |
| Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels | Ziltivekimab 30 mg | -91.64 | Inter-Quartile Range -95.19 to -86.15 | Percent change | |
| Percent Change From Baseline in Serum Amyloid A (SAA) | Placebo | 1.82 | Inter-Quartile Range -18.42 to 50.98 | Percent change | |
| Percent Change From Baseline in Serum Amyloid A (SAA) | Ziltivekimab 7.5 mg | -40.24 | Inter-Quartile Range -61.54 to -12.38 | Percent change | |
| Percent Change From Baseline in Serum Amyloid A (SAA) | Ziltivekimab 15 mg | -49.80 | Inter-Quartile Range -63.90 to -31.54 | Percent change | |
| Percent Change From Baseline in Serum Amyloid A (SAA) | Ziltivekimab 30 mg | -42.45 | Inter-Quartile Range -68.91 to -13.48 | Percent change | |
| Percent Change From Baseline in Fibrinogen | Placebo | -1.62 | Inter-Quartile Range -12.90 to 13.35 | Percent change | |
| Percent Change From Baseline in Fibrinogen | Ziltivekimab 7.5 mg | -25.20 | Inter-Quartile Range -33.27 to -7.93 | Percent change |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 66 | |
| Overall Study | STARTED | Ziltivekimab 7.5 mg | 66 | |
| Overall Study | STARTED | Ziltivekimab 15 mg | 66 | |
| Overall Study | STARTED | Ziltivekimab 30 mg | 66 | |
| Overall Study | Intent-to-treat Analysis Population | Placebo | 66 | |
| Overall Study | Intent-to-treat Analysis Population | Ziltivekimab 7.5 mg | 66 | |
| Overall Study | Intent-to-treat Analysis Population | Ziltivekimab 15 mg | 66 | |
| Overall Study | Intent-to-treat Analysis Population | Ziltivekimab 30 mg | 66 | |
| Overall Study | Safety Analysis Population | Placebo | 65 | |
| Overall Study | Safety Analysis Population | Ziltivekimab 7.5 mg | 65 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events224
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 1 | 65 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ziltivekimab 7.5 mg | 4 | 65 | 5 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ziltivekimab 15 mg | 2 | 66 | 2 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ziltivekimab 30 mg | 1 | 65 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 5 | 65 | 5 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Ziltivekimab 7.5 mg | 1 | 65 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Ziltivekimab 15 mg | 3 | 66 | 3 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Ziltivekimab 30 mg | 2 | 65 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 65 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Ziltivekimab 7.5 mg | 2 | 65 | 2 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 65 |
| Total, all-cause mortality | Ziltivekimab 7.5 mg | 0 | 65 |
| Total, all-cause mortality | Ziltivekimab 15 mg | 0 | 66 |
| Total, all-cause mortality | Ziltivekimab 30 mg | 0 | 65 |
| Total, other adverse events | Placebo | 19 | 65 |
| Total, other adverse events | Ziltivekimab 7.5 mg | 22 | 65 |
| Total, other adverse events | Ziltivekimab 15 mg | 18 | 66 |
| Total, other adverse events | Ziltivekimab 30 mg | 17 | 65 |
| Total, serious adverse events | Placebo | 10 | 65 |
| Total, serious adverse events | Ziltivekimab 7.5 mg | 13 | 65 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03926117
GET https://conductscience.org/api/trials/v1/NCT03926117/results?page=2