免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition (RESCUE)

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

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Inflammation Biological: Ziltivekimab Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Matching placebo
Primary Purpose: Treatment
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
Actual Study Start Date : June 3, 2019
Actual Primary Completion Date : June 26, 2020
Actual Study Completion Date : June 26, 2020
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: Placebo
Matching placebo
 Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Name: COR-001
Experimental: Ziltivekimab 7.5 mg Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Name: COR-001
Experimental: Ziltivekimab 15 mg Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Name: COR-001
Experimental: Ziltivekimab 30 mg Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Name: COR-001
Outcome Measures
Primary Outcome Measures :
  1. Inflammation [ Time Frame: 24 weeks ]
    CRP


Secondary Outcome Measures :
  1. NT-proBNB [ Time Frame: 24-weeks ]
  2. Hemoglobin [ Time Frame: 24-weeks ]
  3. Albumin [ Time Frame: 24-weeks ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Show Show 49 study locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
Tracking Information
First Submitted Date  ICMJE April 19, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date June 8, 2021
Actual Study Start Date  ICMJE June 3, 2019
Actual Primary Completion Date June 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019) 		Inflammation [ Time Frame: 24 weeks ]
CRP
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • NT-proBNB [ Time Frame: 24-weeks ]
  • Hemoglobin [ Time Frame: 24-weeks ]
  • Albumin [ Time Frame: 24-weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Matching placebo
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Diseases
  • Inflammation
Intervention  ICMJE Biological: Ziltivekimab
human IgG1k anti-human IL-6 monoclonal antibody
Other Name: COR-001
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Biological: Ziltivekimab
  • Experimental: Ziltivekimab 7.5 mg
    Intervention: Biological: Ziltivekimab
  • Experimental: Ziltivekimab 15 mg
    Intervention: Biological: Ziltivekimab
  • Experimental: Ziltivekimab 30 mg
    Intervention: Biological: Ziltivekimab
Publications * 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 14. pii: S0140-6736(21)00520-1. doi: 10.1016/S0140-6736(21)00520-1. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2020) 		264
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2019) 		240
Actual Study Completion Date  ICMJE June 26, 2020
Actual Primary Completion Date June 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926117
Other Study ID Numbers  ICMJE NN6018-4779
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯