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New drug aims to calm inflammation in kidney dialysis patients

NCT ID NCT07619820

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This early-stage trial tests a drug called CSL300 (clazakizumab) in 24 Chinese adults with end-stage kidney disease who are on dialysis. The drug is an antibody that blocks interleukin-6, a protein involved in inflammation. The main goal is to see how the drug moves through the body and whether it is safe, not yet to measure if it improves health.

What this could mean

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

Active substance
Clazakizumab (CSL300), a lab-made antibody that blocks interleukin-6, given as an injection
What this could lead to
If successful, this could point toward a new way to reduce inflammation in dialysis patients, potentially improving their long-term outcomes.
What could go wrong
This is a very early (Phase 1b), small (24 people) safety and dosing study. It is not designed to prove the drug works, and side effects like infections are a known risk with this type of drug.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

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: * Participants has provided written informed consent and is willing and able to adhere to all protocol requirements. * Aged 18 or older, inclusive, at the time of providing written informed consent. * Diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks before Screening. Exclusion Criteria: * Exclusion related to risk of infection: concomitant use of systemic immunosuppressant agents, primary immunodeficiency, positive test for active tuberculosis (TB), history of latent TB without completion of full course of prophylactic treatment, evidence of human immunodeficiency virus infection during Screening, seropositivity for hepatitis B surface antigen or positive hepatitis B virus (HBV) DNA during Screening, seropositivity for hepatitis C virus ribonucleic acid during Screening, diagnosis of clinically significant active infection, history of / OR current invasive fungal infection OR other opportunistic infection OR recurrent cellulitis (defined as 2 or more episodes in the year prior to screening), administration of a live vaccine within 6 weeks of start of Screening, presence of urinary catheter, or evidence of wet gangrene or nonhealing ulcers. * Exclusion related to laboratory abnormalities: abnormal liver function tests, neutropenia, thrombocytopenia, or significant anemia. * Exclusion related to medical history: any life-threatening disease expected to result in death within 12 months (other than cardiovascular disease), evidence of active hepatic disease and / or moderate or severe hepatic impairment, recent unplanned hospitalization (\< 30 days) prior to Screening, recent (\< 3 months) major surgery or planned major surgery known at the time of Screening, poorly controlled hypertension, a present or previous (\< 5 years) malignancy except for basal cell carcinoma, fully excised squamous cell carcinoma of the skin, or nonrecurrent (\< 5 years of Screening) cervical carcinoma in situ, active or recent (\< 30 days of Screening) clinically severe bleeding, a scheduled kidney transplant within 6 months of Screening, a history of anaphylaxis or hypersensitivity to CSL300 or any constituents of the product, or a history of demyelinating disorders. * Exclusion related to risk of gastrointestinal perforation: a history of GI perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease (\< 12 months before Screening), a history of diverticular disease or diverticulitis (except if disease has been fully excised). An incidental finding of diverticulosis (presence of small diverticula) and no history of symptoms, complications, or any episodes requiring treatment may be eligible for the study based on investigator's judgment. However, any history of complications, inflammation, or infection suggestive of diverticulitis or diverticular disease is exclusionary, inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis except if fully excised, or prior gastric bypass surgery. * Exclusion related to treatment compliance: evidence of inadequate dialysis, unwillingness or inability to comply with study procedures, a history of noncompliance with medical treatments, or ongoing alcohol or illicit substance abuse. * Current or recent participation in research study involving an experimental agent \< 3 months of Screening. * Pregnant, breastfeeding, or unwillingness to practice adequate contraception during the study and for 5 months after the last dose of investigational product. * The presence of any condition that in the opinion of the Investigator would (1) compromise the safety of the participant in case of participation in the study, (2) compromise the quality of the data, and / or (3) limit the life expectancy of the participant to \< 1 year. * The Sponsor determines that the participant is no longer needed for participation in 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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University People's Hospital

    RECRUITING

    Beijing, 100044, China

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