Not Yet RecruitingPhase 1

A Phase 1b Study to Evaluate the PK of CSL300 (Clazakizumab) in Chinese Subjects With End Stage Kidney Disease (ESKD)

24 participantsStarted 2026-06-30

Plain-language summary

This is a phase 1b, partial-blind (Sponsor unblinded), randomized, multicenter, placebo-controlled study. The primary objective of this study is to evaluate the pharmacokinetics (PK) of CSL300 after single and multiple doses in Chinese participants with end stage kidney disease (ESKD) undergoing dialysis.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is specifically enrolling Chinese subjects with end-stage kidney disease — does my background and health situation match what they're looking for, and is it even worth discussing enrollment with the study team?
2Since this is a Phase 1b trial focused on how CSL300 is absorbed and processed in the body rather than on proving it treats ESKD, what does that mean for my personal safety and the likelihood of any direct benefit to me?
3The trial isn't recruiting yet — given where I am in my treatment right now, is the timing realistic, and should I be doing something else in the meantime while waiting for enrollment to open?
4CSL300 is an anti-IL-6 antibody being studied in kidney disease — are there already approved treatments targeting similar pathways that I should consider before looking at an early-phase study like this one?
5What would my care look like during this trial given that it's measuring drug levels over multiple doses, and how demanding would the visit schedule and blood draws be on my daily life?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the Concentration-time (AUC) Curve of CSL300 Over 1 Dosing Interval After Multiple Doses (AUC0-tau,MD)

Timeframe: Day 85 up to Day 113

Trough Concentration at Steady State (Ctrough,ss)

Timeframe: Up to Day 141

Trial details

NCT IDNCT07619820

SponsorCSL Behring

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08-30

Contact for this trial

Trial Registration Coordinator

+16108784697 clinicaltrials@cslbehring.com

View on ClinicalTrials.gov More End Stage Kidney Disease (ESKD) trials