Phase 2 Completed N=264 Randomized Quadruple-blind Treatment

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

Chronic Kidney Diseases · Inflammation

Source: ClinicalTrials.gov NCT03926117 ↗

Enrolled (actual)

264

Serious AEs

15.3%

Results posted

Aug 2023

Primary outcomePrimary: Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels — -4.49; -76.57; -88.12; -91.64 Percent change — p=<0.0001

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels	-4.49; -76.57; -88.12; -91.64	<0.0001 sig
SECONDARY Percent Change From Baseline in Serum Amyloid A (SAA)	1.82; -40.24; -49.80; -42.45	—
SECONDARY Percent Change From Baseline in Fibrinogen	-1.62; -25.20; -24.69; -37.17	—
SECONDARY 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	69.2; 66.2; 66.7; 72.3; 15.4; 20.0	—
SECONDARY Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Events	0.0; 0.0; 0.0; 0.0	—
SECONDARY Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI)	4.6; 10.8; 4.5; 3.1; 1.5; 0.0	—
SECONDARY Change in Systolic Blood Pressure (SBP)	4.8; 4.9; 0.6; 1.2	—
SECONDARY Change in Diastolic Blood Pressure (DBP)	0.7; 2.9; 1.1; 3.1	—
SECONDARY Change in Respiratory Rate	0.4; 0.2; -0.7; -0.5	—
SECONDARY Change in Body Mass Index (BMI)	0.13; 0.51; 0.58; 0.40	—
SECONDARY Change in Heart Rate	2.8; 1.5; -0.6; 1.2	—
SECONDARY Change in Temperature	0.03; -0.01; -1.13; -0.02	—
SECONDARY Change in Electrocardiogram (ECG)	0; 0; 0; 0; 44; 38	—
SECONDARY Change in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AAT) Levels	-1.9; -6.3; -9.6; -15.7; 1.3; 2.6	—
SECONDARY Change in Bicarbonate, Chloride, Potassium, Sodium	-0.9; -0.3; -0.7; -1.2; 1.7; 0.0	—
SECONDARY Change in Direct Bilirubin, Bilirubin, Calcium, Creatinine, Glucose, Phosphate and Urea Nitrogen	-0.007; 0.008; 0.018; 0.009; -0.028; 0.060	—
SECONDARY Follicle Stimulating Hormone (FSH) Levels	57.45; 72.70; 77.49; 58.79	—
SECONDARY Number of Participants With Anti-drug Antibodies (ADAs)	0; 4; 5; 7	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03926117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.