| Eligibility |
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 4. The patient agrees to comply with
- The patient agrees to comply with the contraception and reproduction restrictions of
the study as follows:
1. 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;
2. 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;
3. Women of childbearing potential must have a documented negative serum pregnancy
test result at screening; and
4. 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
- Expected to require blood transfusion within 12 weeks post-randomization;
- Thromboembolic event within 12 weeks prior to randomization;
- Clinical evidence or suspicion of active infection;
- History of peptic ulcer disease or gastrointestinal ulceration in the 12 months prior
to randomization;
- History of active diverticulitis in the 12 months prior to randomization;
- History of inflammatory bowel disease that has been clinically active during the 12
months prior to randomization;
- Uncontrolled hypertension (defined as an average systolic blood pressure above 160
mmHg or an average diastolic blood pressure above 100 mmHg) during screening. Patients
may be re-evaluated within 2 weeks, at the discretion of the Principal Investigator,
for this criterion if antihypertensive therapy has been started or increased as a
result of initial screening blood pressure being above these limits;
- Planned coronary revascularization (percutaneous coronary intervention or coronary
artery bypass grafting) or any other major surgical procedure during the time frame of
the study;
- Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure within the
past 6 months prior to randomization;
- Prior gastric bypass surgery;
- History of New York Heart Association (NYHA) Class IV congestive heart failure within
12 weeks prior to randomization;
- Diagnosis of malignancy within 1 year prior to randomization with the exception of
successfully treated nonmetastatic basal cell or squamous cell carcinomas of the skin
and/or local carcinoma in situ of the cervix;
- History of bone marrow or solid organ transplant or anticipated to receive an organ
transplant during the time frame of the study;
- Known allergy to the study drug or any of its ingredients;
Prior or current medications
- Received an investigational drug within 30 days prior to screening;
- Received a live vaccine product within 14 days of study drug administration or expect
to receive live vaccine during the treatment period;
- Expected to receive any investigational drug or any of the exclusionary drugs during
the treatment period or safety follow-Up period;
- Chronic use of systemic immunosuppressive drugs during the screening period or
anticipated use of such drugs any time during the study. Note: Use of otic,
ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections
are not exclusionary. Oral prednisone up to 5 mg per day (or equivalent) is permitted
if the dose has been stable for at least 4 weeks prior to Screening and no dose
changes are planned during study participation. Short-term use of oral steroids for
treatment of rash or asthma exacerbation is allowed;
- Use of systemic antibiotics, systemic antivirals, or systemic antifungals during the
screening period. Note: "Systemic" is defined as oral or intravenous drugs that are
absorbed into the circulation;
- Requirement of an indwelling catheter of any type; 28. Use of hypoxia-inducible factor
(HIF) stabilizers or erythropoiesis-stimulating agents (ESA) within 6 weeks of
randomization or during the treatment period;
General exclusions
- Currently breastfeeding; or
- Any condition that could interfere with, or for which the treatment might interfere
with, the conduct of the study or interpretation of the study results, or that would
in the opinion of the Investigator increase the risk of participating in the study.
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