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Could an antibody tame inflammation in kidney patients?

NCT ID NCT03926117

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called ziltivekimab in 264 people with advanced chronic kidney disease and high inflammation. Participants received monthly injections of either a placebo or one of three doses of ziltivekimab for six months. The goal was to see if the drug could safely lower inflammation markers, which might reduce the risk of heart problems in these patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ziltivekimab (an antibody that blocks IL-6, a protein involved in inflammation)
What this could lead to
If successful, this could lead to a new treatment to lower inflammation and potentially reduce heart problems in people with advanced kidney disease.
What could go wrong
This is an early-phase trial with only 264 participants, so results may not apply to everyone. The drug may not work as hoped or could cause side effects like infections.

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

264 people

The number who actually took part.

Started

Jun 2019

Finished

Jun 2020

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

18 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: * 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

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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

  • AMPM Research Clinic

    Miami, Florida, 33169, United States

  • Apex Research of Riverside

    Riverside, California, 92505, United States

  • Arizona Kidney Disease and Hypertension Center

    Phoenix, Arizona, 85016, United States

  • Aventiv Research

    Mesa, Arizona, 85210, United States

  • Biopharma Informatick Inc. Research Center

    Houston, Texas, 77043, United States

  • Capital Nephrology

    Greenbelt, Maryland, 20770, United States

  • Central Alabama Research

    Birmingham, Alabama, 35205, United States

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212, United States

  • Clinical Investigation Specialist, Inc

    Kenosha, Wisconsin, 53142, United States

  • Clinical Trials of America, LLC - West Monroe

    Monroe, Louisiana, 71201, United States

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904, United States

  • DaVita Clinical Research

    Minneapolis, Minnesota, 55404, United States

  • DaVita Clinical Research

    The Bronx, New York, 10461, United States

  • Elite Clinical Studies

    Phoenix, Arizona, 85018, United States

  • Florida Premier Research Institue, LLC

    Winter Park, Florida, 32789, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Investigator Research by Design, LLC

    Chicago, Illinois, 60643, United States

  • Julia and Israel Waldbaum Dialysis Center

    Great Neck, New York, 11021, United States

  • Juno Research, LLC - Northwest

    Houston, Texas, 77070, United States

  • Knoxville Kidney Center, PLLC

    Knoxville, Tennessee, 37923, United States

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • Metrolina Nephrology Associates

    Charlotte, North Carolina, 28277, United States

  • Metrolina Nephrology Associates, PA

    Charlotte, North Carolina, 28207, United States

  • Mountain Kidney and Hypertension Associates

    Asheville, North Carolina, 28801, United States

  • Mountain View CLinical Research - Greer

    Greer, South Carolina, 29651, United States

  • Nephrology Associates, PC

    Nashville, Tennessee, 37205, United States

  • Nephrology Research of Michigan

    Saint Clair Shores, Michigan, 48081, United States

  • North America Research Institute

    Lynwood, California, 90262, United States

  • North America Research Institute

    Riverside, California, 92503, United States

  • North America Research Institute

    San Dimas, California, 91773, United States

  • North Hills Medical Research, Inc

    North Richland Hills, Texas, 76180, United States

  • Northeast Clinical Research Center

    Allentown, Pennsylvania, 18104, United States

  • Northport VAMC

    Northport, New York, 11768, United States

  • Ocala Cardiovascular Research

    Ocala, Florida, 34474, United States

  • Onyx Clinical Research

    Caro, Michigan, 48723, United States

  • Piedmont Research Partners, LLC

    Fort Mill, South Carolina, 29707, United States

  • Renal Disease Research Institute

    Dallas, Texas, 75246, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • San Antonio Kidney Disease Center Physicians Group, PLLC

    San Antonio, Texas, 78229, United States

  • Southeastern Clinical Research Institute, LLC

    Augusta, Georgia, 30901, United States

  • Southeastern Nephrology - Whiteville

    Whiteville, North Carolina, 28472, United States

  • Southeastern Nephrology Associates - Wilmington

    Wilmington, North Carolina, 28401, United States

  • Southside Urology and Nephrology

    Danville, Virginia, 25241, United States

  • St. Clair Nephrology Research

    Roseville, Michigan, 48066, United States

  • Summit Research Group, LLC

    Stow, Ohio, 44224, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Vermont

    Burlington, Vermont, 05401, United States

  • Vilo Research Group, Inc

    Houston, Texas, 77017, United States

  • Western Nephrology and Metabolic Bone Disease, PC

    Arvada, Colorado, 80002, United States

More trials for these conditions

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