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New drug aims to tame inflammation in kidney patients

NCT ID NCT04626505

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug, ziltivekimab, in 36 adults with advanced chronic kidney disease (not on dialysis) to see if it can safely reduce inflammation and related heart risks. Participants received either a low dose, a high dose, or a placebo injection every 4 weeks for 3 doses. The main goal was to measure changes in a blood marker of inflammation (hs-CRP) over 12 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

36 people

The number who actually took part.

Started

Oct 2020

Finished

Sep 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Ehime Medical Center

    Ehime, 791-0281, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.