Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition (RESCUE)
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ClinicalTrials.gov Identifier: NCT03926117 |
Recruitment Status :
Completed
First Posted : April 24, 2019
Last Update Posted : July 14, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Kidney Diseases Inflammation | Biological: Ziltivekimab | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Matching placebo
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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 |
- Inflammation [ Time Frame: 24 weeks ]CRP
- NT-proBNB [ Time Frame: 24-weeks ]
- Hemoglobin [ Time Frame: 24-weeks ]
- Albumin [ Time Frame: 24-weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926117

Responsible Party: | Corvidia Therapeutics |
ClinicalTrials.gov Identifier: | NCT03926117 |
Other Study ID Numbers: |
COR-001-02 |
First Posted: | April 24, 2019 Key Record Dates |
Last Update Posted: | July 14, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
IL-6 CRP Chronic Kidney Disease Cardiovascular Disease Inflammation |
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Inflammation |
Pathologic Processes Urologic Diseases Renal Insufficiency |