A Phase 2/3 interventional study of CSL300 and Placebo in End Stage Kidney Disease, sponsored by CSL Behring. Recruiting at 566 sites in 35 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by CSL Behring (part of CSL Limited) · Phase 2/3, Interventional, and Supportive care
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study.
Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo. Part 2: Phase 3 aims to assess the efficacy of CSL300 vs placebo on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 3,110 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →CSL Behring is the lead sponsor of 145 studies on the registry; 17 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.
First submitted after CSL Behring became part of CSL Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous (IV) administration
Drug: CSL300
IV administration
Drug: CSL300
IV administration
Drug: CSL300
IV administration
Drug: Placebo
IV administration
Drug: CSL300
IV administration
Drug: Placebo
IV administration
Also known as: Clazakizumab
Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.
Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)
Time frame: Baseline and up to Week 12
Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3)
Time frame: Approximately 5 years
Percent of participants achieving hs-CRP less than (<) 2.0 milligram per Liter (mg/L) (Phase 2b)
Time frame: Week 12
Change from baseline in log-transformed hs-CRP (Phase 2b)
Time frame: Baseline and up to Week 24
Mean change from Baseline in serum amyloid A (SAA) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in secretory phospholipase A2 (sPLA2) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in fibrinogen (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in plasminogen activator inhibitor -1 (PAI-1) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in lipoprotein (Lp) (a) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in albumin (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in Hepcidin (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in hemoglobin (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in erythropoiesis-stimulating agents (ESA) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in erythropoietin-resistance index (ERI) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in iron (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in total iron binding capacity (TIBC) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in transferrin saturation (TSAT) (Phase 2b)
Time frame: Baseline and up to Week 12
Mean change from Baseline in ferritin (Phase 2b)
Time frame: Baseline and up to Week 12
Area under the plasma concentration versus time curve (AUC) for CSL300 (Phase 2b)
Time frame: Up to Week 24
Peak Plasma Concentration (Cmax) for CSL300 (Phase 2b)
Time frame: Up to Week 24
Trough Plasma Concentration (Ctrough) for CSL300 (Phase 2b)
Time frame: Up to Week 24
Time to Maximum Plasma Concentration (Tmax) for CSL300 (Phase 2b)
Time frame: Up to Week 24
Percent of participants with adverse events (AE), serious AE (SAE), including adverse events of special interest (AESIs) (Phase 2b)
Time frame: Up to Week 32
Mean change from Baseline in white blood cell (WBC) (Phase 2b)
Time frame: Up to Week 12
Mean change from Baseline in neutrophils (Phase 2b)
Time frame: Up to Week 12
Mean change from Baseline in platelets (Phase 2b)
Time frame: Up to Week 12
Mean change from Baseline in aspartate aminotransferase (AST) (Phase 2b)
Time frame: Up to Week 12
Mean change from Baseline in alanine aminotransferase (ALT) (Phase 2b)
Time frame: Up to Week 12
Mean change from Baseline in total bilirubin (Phase 2b)
Time frame: Up to Week 12
Mean change from Baseline in lipid panel (Phase 2b)
Lipid panel consists of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride.
Time frame: Up to Week 12
Titer of confirmed antibodies specific to CSL300 (Phase 2b)
Time frame: Up to Week 12
Time to first occurrence of all-cause death or MI (Phase 3)
Time frame: Approximately 5 years
Time to first occurrence of CV death, MI, or ischemic stroke (Phase 3)
Time frame: Approximately 5 years
Time to first occurrence of CV death (Phase 3)
Time frame: Approximately 5 years
Time to first occurrence of CV death, MI or major adverse limb event (Phase 3)
Time frame: Approximately 5 years
Time to first occurrence of all-cause death (Phase 3)
Time frame: Approximately 5 years
Time to first occurrence of CV death, MI, or hospitalization for heart failure (HF) (Phase 3)
Time frame: Up to 5 years
Total number of CV hospitalizations (Phase 3)
Time frame: Approximately 5 years
Total number of HF hospitalizations and urgent visits (Phase 3)
Time frame: Approximately 5 years
Total number of hospitalizations (Phase 3)
Time frame: Approximately 5 years
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Showing the first 100 of 566 sites across 35 countries. Choose a country and city above to see the rest.
Plan to share: Yes — CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
Access criteria: Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Started Apr 2024 (actual). Primary completion is estimated for May 2029, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
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