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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Diseases; Inflammation

Treatments: Biological: Ziltivekimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03926117

NN6018-4779

Details and patient eligibility

About

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.

Enrollment: 264 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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264 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Biological: Ziltivekimab

Ziltivekimab 7.5 mg

Experimental group

Treatment:

Biological: Ziltivekimab

Ziltivekimab 15 mg

Experimental group

Treatment:

Biological: Ziltivekimab

Ziltivekimab 30 mg

Experimental group

Treatment:

Biological: Ziltivekimab