A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody-Mediated Interleukin-6 Inhibition in Japan
Overview
- Phase
- Phase 2
- Intervention
- Ziltivekimab
- Conditions
- Chronic Kidney Disease
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- The difference in the percent change in high-sensitivity C-reactive protein (hs-CRP) levels (average of all hs-CRP values prior to the administration of study drug) between each active group and placebo
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this research study is to compare the safety and effectiveness of 2 different doses of a study drug called ziltivekimab to placebo (an inactive substance) in reducing inflammation and improving some of the bad effects of inflammation on heart disease. Participants will be randomly (by chance) assigned to receive either ziltivekimab or placebo. The chance that participants will be assigned into one of the three study arms of ziltivekimab (either 15 mg or 30 mg) or placebo is the same (approximately 33%). This is a double-blind study, which means neither participants nor the study doctor will know which group the participants are in. In case of an emergency, however, the study doctor can get this information. The study drug will be injected under the skin once every 4 weeks. In this study participants will receive 3 injections of study drug. The total study duration for each participant will be approximately 6 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age equal to or above 20 years at the time of signing the Informed Consent Form
- •Stage 3 to 5 non-dialysis-dependent chronic kidney disease (NDD-CKD), ie, estimated glomerular filtration rate above 10 and below 60 mL/min/1.73 m\^2 using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine equation
- •Serum hs-CRP level equal to or above 2.0 mg/L measured during the screening period. Note: Targeting patients with a history of advanced stage CKD, atherosclerotic cardiovascular disease, anemia, diabetic retinopathy, obesity, or elevated BMI, and diabetes for screening will help increase the chances of identifying patients with hs-CRP equal to or above2.0 mg/L
- •The patient agrees to comply with
- •The patient agrees to comply with the contraception and reproduction restrictions of the study as follows:
- •Women of childbearing potential must be using a method of contraception that is "highly effective" (ie, less than 1% failure rate) for at least 3 months following the last dose of study drug;
- •Postmenopausal women must have had no menstrual bleeding for at least 1 year before initial dosing and either be over the age of 60 years or have an elevated plasma follicle stimulating hormone level (ie, above 40 mIU/mL) at screening;
- •Women of childbearing potential must have a documented negative serum pregnancy test result at screening; and
- •All male patients, from the day of dosing until the final study visit, unless surgically sterile, must be willing to use a condom with a partner (male patients with partners of childbearing potential must be willing to use 2 effective methods of birth control, 1 should be condom with spermicide) to prevent pregnancy and drug exposure of a partner, and refrain from donating sperm or fathering a child; and
- •The patient must be willing and able to provide informed consent and abide all study requirements and restrictions.
Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded from participation in the study:
- •Laboratory values
- •Absolute neutrophil count below 2.0 × 10\^9/L during screening;
- •Platelet count below 120 × 10\^9/L during screening;
- •Spot urine protein-creatinine ratio above 4000 mg/g (4.0 g/g) during screening;
- •Alanine aminotransferase or aspartate aminotransferase above 2.5 × upper limit of normal during screening;
- •Positive testing for tuberculosis during screening. blood testing (eg, QuantiFERON) is preferred, but a purified protein derivative (PPD) skin test read within 48 to 72 hours by a qualified healthcare professional may also be performed. If a patient is PPD positive but QuantiFERON negative, the patient is eligible;
- •Evidence of human immunodeficiency virus (HIV)-1 or HIV-2 infection by serology measured during screening;
- •Hepatitis B or C by serology (eg, hepatitis B surface antigen or hepatitis C antibody positive) measured during screening;
- •Medical conditions or diseases
Arms & Interventions
Ziltivekimab 15 mg
Participants will receive ziltivekimab 15 mg for 12 weeks.
Intervention: Ziltivekimab
Ziltivekimab 30 mg
Participants will receive ziltivekimab 30 mg for 12 weeks.
Intervention: Ziltivekimab
Placebo (ziltivekimab)
Participants will receive placebo (ziltivekimab) for 12 weeks.
Intervention: Placebo (ziltivekimab)
Outcomes
Primary Outcomes
The difference in the percent change in high-sensitivity C-reactive protein (hs-CRP) levels (average of all hs-CRP values prior to the administration of study drug) between each active group and placebo
Time Frame: From baseline (week 0) to the end of treatment (week 12)
Percent change
Secondary Outcomes
- Participants with AEs leading to discontinuation(From randomisation (week 0) to week 20)
- Number of adverse events (AEs)(From randomisation (week 0) to week 20)
- Number of serious adverse events (SAEs)(From randomisation (week 0) to week 20)