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New treatment option for End Stage Kidney Disease (ESKD)
Official title A Phase 1b Study to Evaluate the PK of CSL300 (Clazakizumab) in Chinese Subjects With End Stage Kidney Disease (ESKD)
ClinicalTrials.gov ID: NCT07619820
What this study is testing
What is CSL300?
CSL300 is an investigational medicine, being studied as a potential treatment for end stage kidney disease (eskd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Exclusion related to risk of infection: concomitant use of systemic immunosuppressant agents, primary immunodeficiency, positive test for active...
- 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)...
- Exclusion related to risk of gastrointestinal perforation: a history of GI perforation, inflammatory bowel disease (except fully excised ulcerative...
- Exclusion related to treatment compliance: evidence of inadequate dialysis, unwillingness or inability to comply with study procedures, a history of...
- Current or recent participation in research study involving an experimental agent \< 3 months of Screening.
See the full eligibility 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 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...
- 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...
- 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...
- 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...
- 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 Sponsor determines that the participant is no longer needed for participation in study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.