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Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition (RESCUE)

Primary Purpose

Chronic Kidney Diseases, Inflammation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ziltivekimab
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 Diseases focused on measuring IL-6, CRP, Chronic Kidney Disease, Cardiovascular Disease, Inflammation

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age
  • Stage 3-5 CKD
  • hs-CRP > 2.0 mg/L
  • Comply with contraception

Exclusion Criteria:

  • Low neutrophil count
  • Low platelet count
  • Spot urine protein to creatinine ration > 4000 mg/g
  • ALT/AST >2.5x ULN
  • TSAT < 10%
  • Positive TB test
  • Evidence of HIV, hepatitis B
  • Blind or illiterate
  • Expected to require blood transfusion
  • Thromboembolic event within 12-weeks
  • Evidence of active infection
  • Peptic ulcer disease, diverticulitis, inflammatory bowel disease
  • Uncontrolled hypertension
  • Planned coronary revascularization
  • Major cardiac surgery, CHF
  • Active malignancy, bone marrow or organ transplant
  • Allergy to study drug
  • Treatment with investigational drug, treatment with HIF stabilizer or ESA
  • Use of immunosuppressive drugs, systemic antibiotics
  • Breastfeeding, any other significant medical history

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • 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 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Ziltivekimab 7.5 mg

Ziltivekimab 15 mg

Ziltivekimab 30 mg

Arm Description

Matching placebo

Outcomes

Primary Outcome Measures

Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels
Percent change from baseline in hs-CRP levels at week 13 are presented.

Secondary Outcome Measures

Percent Change From Baseline in Serum Amyloid A (SAA)
Percent change from baseline in SAA at week 13 are presented.
Percent Change From Baseline in Fibrinogen
Percent change from baseline in fibrinogen at week 13 are presented.
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
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.
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Events
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.
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI)
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.
Change in Systolic Blood Pressure (SBP)
Change from baseline in systolic blood pressure at week 32 are presented.
Change in Diastolic Blood Pressure (DBP)
Change from baseline in diastolic blood pressure at week 32 are presented.
Change in Respiratory Rate
Change from baseline in respiratory rate at week 32 are presented.
Change in Body Mass Index (BMI)
Change from baseline in BMI at week 24 are presented.
Change in Heart Rate
Change from baseline in heart rate at Week 32 are presented.
Change in Temperature
Change from baseline in temperature at week 32 are presented.
Change in Electrocardiogram (ECG)
The ECG was assessed by the investigator at baseline (week -1) and week 24 and categorised as abnormal clinically significant, abnormal not clinically significant, indeterminate, normal, not evaluable and unknown. Number of participants in each ECG category at baseline and week 24 are presented.
Change in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AAT) Levels
Change from baseline in ALP, ALT and AAT levels at week 32 are presented.
Change in Bicarbonate, Chloride, Potassium, Sodium
Change from baseline in bicarbonate, chloride, potassium, sodium at week 32 are presented.
Change in Direct Bilirubin, Bilirubin, Calcium, Creatinine, Glucose, Phosphate and Urea Nitrogen
Change from baseline in direct bilirubin, bilirubin, calcium, creatinine, glucose, phosphate and urea nitrogen at week 32 are presented.
Follicle Stimulating Hormone (FSH) Levels
FSH levels at baseline (week -1) are presented.
Number of Participants With Anti-drug Antibodies (ADAs)
Participants who had at least 1 positive sample (treatment-boosted or treatment-induced) at any time after their first Ziltivekimab administration were classified as positive for ADAs. In the instance that a participant had a positive sample at the baseline visit, the participant was considered positive only if the peak titer of the post-treatment sample was at least 2-fold higher (i.e., >=2-fold) than the titer of the baseline sample. Number of participants positive for antibodies to Ziltivekimab are presented.

Full Information

First Posted
April 19, 2019
Last Updated
August 8, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03926117
Brief Title
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
Acronym
RESCUE
Official Title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
June 26, 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with chronic kidney disease, who have evidence of systemic inflammation with increased cardiovascular risk, will be enrolled into this trial. The purpose of this trial is to determine a dose to select for a potential cardiovascular outcome trial with Ziltivekimab. Doses to be tested will be 7.5 mg, 15 mg and 30 mg subcutaneous monthly compared to placebo for six months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Inflammation
Keywords
IL-6, CRP, Chronic Kidney Disease, Cardiovascular Disease, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Matching placebo
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Arm Title
Ziltivekimab 7.5 mg
Arm Type
Experimental
Arm Title
Ziltivekimab 15 mg
Arm Type
Experimental
Arm Title
Ziltivekimab 30 mg
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Ziltivekimab
Other Intervention Name(s)
COR-001
Intervention Description
human IgG1k anti-human IL-6 monoclonal antibody
Primary Outcome Measure Information:
Title
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels
Description
Percent change from baseline in hs-CRP levels at week 13 are presented.
Time Frame
Baseline (average of the hs-CRP value prior to randomization and day 1), week 13
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Serum Amyloid A (SAA)
Description
Percent change from baseline in SAA at week 13 are presented.
Time Frame
Baseline (average of the values at week -1 and day 1), week 13
Title
Percent Change From Baseline in Fibrinogen
Description
Percent change from baseline in fibrinogen at week 13 are presented.
Time Frame
Baseline (day 1), week 13
Title
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
Description
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.
Time Frame
From week 0 to week 32
Title
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Events
Description
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.
Time Frame
From week 0 to week 32
Title
Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI)
Description
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.
Time Frame
From week 0 to week 32
Title
Change in Systolic Blood Pressure (SBP)
Description
Change from baseline in systolic blood pressure at week 32 are presented.
Time Frame
Baseline (week 1), week 32
Title
Change in Diastolic Blood Pressure (DBP)
Description
Change from baseline in diastolic blood pressure at week 32 are presented.
Time Frame
Baseline (week 1), week 32
Title
Change in Respiratory Rate
Description
Change from baseline in respiratory rate at week 32 are presented.
Time Frame
Baseline (week 1), week 32
Title
Change in Body Mass Index (BMI)
Description
Change from baseline in BMI at week 24 are presented.
Time Frame
Baseline (week 1), week 24
Title
Change in Heart Rate
Description
Change from baseline in heart rate at Week 32 are presented.
Time Frame
Baseline (week 1), week 32
Title
Change in Temperature
Description
Change from baseline in temperature at week 32 are presented.
Time Frame
Baseline (week 1), week 32
Title
Change in Electrocardiogram (ECG)
Description
The ECG was assessed by the investigator at baseline (week -1) and week 24 and categorised as abnormal clinically significant, abnormal not clinically significant, indeterminate, normal, not evaluable and unknown. Number of participants in each ECG category at baseline and week 24 are presented.
Time Frame
Baseline (week -1), Week 24
Title
Change in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AAT) Levels
Description
Change from baseline in ALP, ALT and AAT levels at week 32 are presented.
Time Frame
Baseline (week 1), week 32
Title
Change in Bicarbonate, Chloride, Potassium, Sodium
Description
Change from baseline in bicarbonate, chloride, potassium, sodium at week 32 are presented.
Time Frame
Baseline (week 1), week 32
Title
Change in Direct Bilirubin, Bilirubin, Calcium, Creatinine, Glucose, Phosphate and Urea Nitrogen
Description
Change from baseline in direct bilirubin, bilirubin, calcium, creatinine, glucose, phosphate and urea nitrogen at week 32 are presented.
Time Frame
Baseline (week 1), week 32
Title
Follicle Stimulating Hormone (FSH) Levels
Description
FSH levels at baseline (week -1) are presented.
Time Frame
Baseline (week -1)
Title
Number of Participants With Anti-drug Antibodies (ADAs)
Description
Participants who had at least 1 positive sample (treatment-boosted or treatment-induced) at any time after their first Ziltivekimab administration were classified as positive for ADAs. In the instance that a participant had a positive sample at the baseline visit, the participant was considered positive only if the peak titer of the post-treatment sample was at least 2-fold higher (i.e., >=2-fold) than the titer of the baseline sample. Number of participants positive for antibodies to Ziltivekimab are presented.
Time Frame
From week 0 to week 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age Stage 3-5 CKD hs-CRP > 2.0 mg/L Comply with contraception Exclusion Criteria: Low neutrophil count Low platelet count Spot urine protein to creatinine ration > 4000 mg/g ALT/AST >2.5x ULN TSAT < 10% Positive TB test Evidence of HIV, hepatitis B Blind or illiterate Expected to require blood transfusion Thromboembolic event within 12-weeks Evidence of active infection Peptic ulcer disease, diverticulitis, inflammatory bowel disease Uncontrolled hypertension Planned coronary revascularization Major cardiac surgery, CHF Active malignancy, bone marrow or organ transplant Allergy to study drug Treatment with investigational drug, treatment with HIF stabilizer or ESA Use of immunosuppressive drugs, systemic antibiotics Breastfeeding, any other significant medical history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60643
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Caro
State/Province
Michigan
ZIP/Postal Code
48723
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Northport
State/Province
New York
ZIP/Postal Code
11768
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Whiteville
State/Province
North Carolina
ZIP/Postal Code
28472
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Stow
State/Province
Ohio
ZIP/Postal Code
44224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77017
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Danville
State/Province
Virginia
ZIP/Postal Code
25241
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States

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
Citations:
PubMed Identifier
35212585
Citation
Kreiner FF, Kraaijenhof JM, von Herrath M, Hovingh GKK, von Scholten BJ. Interleukin 6 in diabetes, chronic kidney disease, and cardiovascular disease: mechanisms and therapeutic perspectives. Expert Rev Clin Immunol. 2022 Apr;18(4):377-389. doi: 10.1080/1744666X.2022.2045952. Epub 2022 Mar 1.
Results Reference
result
PubMed Identifier
34015342
Citation
Ridker PM, Devalaraja M, Baeres FMM, Engelmann MDM, Hovingh GK, Ivkovic M, Lo L, Kling D, Pergola P, Raj D, Libby P, Davidson M; RESCUE Investigators. IL-6 inhibition with ziltivekimab in patients at high atherosclerotic risk (RESCUE): a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2021 May 29;397(10289):2060-2069. doi: 10.1016/S0140-6736(21)00520-1. Epub 2021 May 17.
Results Reference
derived

Learn more about this trial

Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition

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