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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Diseases, Inflammation

In brief

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.

Key facts

Study ID

NCT03926117

Run by

Novo Nordisk A/S

People needed

264

Starts

2019-06-03

Expected to finish

2020-06-26

Last updated by the study team

2025-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Central Alabama Research — Birmingham, Alabama, United States
• Aventiv Research — Mesa, Arizona, United States
• Arizona Kidney Disease and Hypertension Center — Phoenix, Arizona, United States
• Elite Clinical Studies — Phoenix, Arizona, United States
• North America Research Institute — Lynwood, California, United States
• North America Research Institute — Riverside, California, United States
• Apex Research of Riverside — Riverside, California, United States
• North America Research Institute — San Dimas, California, United States
• Western Nephrology and Metabolic Bone Disease, PC — Arvada, Colorado, United States
• AMPM Research Clinic — Miami, Florida, United States
• Ocala Cardiovascular Research — Ocala, Florida, United States
• Florida Premier Research Institue, LLC — Winter Park, Florida, United States
• Southeastern Clinical Research Institute, LLC — Augusta, Georgia, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• Investigator Research by Design, LLC — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Clinical Trials of America, LLC - West Monroe — Monroe, Louisiana, United States
• Capital Nephrology — Greenbelt, Maryland, United States
• Onyx Clinical Research — Caro, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• St. Clair Nephrology Research — Roseville, Michigan, United States
• Nephrology Research of Michigan — Saint Clair Shores, Michigan, United States
• DaVita Clinical Research — Minneapolis, Minnesota, United States
• Julia and Israel Waldbaum Dialysis Center — Great Neck, New York, United States
• Northport VAMC — Northport, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.